A Prospective, Multicenter Evaluation of the CD HORIZON® Fenestrated Screw Spinal System With Fenestrated Screw Cement When Used in the Treatment of Spinal Conditions in Subjects With Compromised Bone Quality
Phase: NA
Conditions: Degenerative Spinal Disease, Deformity of Spine
Sponsor: Medtronic Spinal and Biologics

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Title
Document Approver
Document Approver
Document Approver
09/20/2018 14:05:19
1.0
09/20/2018 10:31:08
Bachinin, Anton
Clinical Investigation Plan FNS study Version 2.0.pdf
Document Approver
Sicurella, Beatrice Carlotta
09/20/2018 12:15:50
Tang, Feng
09/20/2018 08:29:50
Faria, Cristina
van Deursen, Carine
Document Approver
Document Approver
09/20/2018 10:27:32
Matysek, Adrianna
09/20/2018 10:50:51
Cristea, Alexander
Limpens, Halina
09/20/2018 09:19:16
09/20/2018 09:21:02
Document Author
Document Approver
Clinical Investigation Plan FNS study Version 2.0.pdf

 Clinical Study Document Approval Form 
 
Form 
 056-F154 
Revision  A 
Page 1 of 2 
 
 
This document is electronically controlled                 Medtronic Confidential    
 
Version 2.0 linked to CIP v2.0, 19 SEP 2018                      
 
 
 
Clinical Study Document Approval Form 
Study Name/Identifier  FNS Study / MDT17040SD1703 
Document Name FNS Study - Clinical Investigation Plan 
Document Version and Date 2.0 / 19 SEP 2018  
Document Reference Number Not applicable 
 
 
Author Name:  
Beatrice C. Sicurella  
Role or Title:  
Medical Writer and Clinical Study Manager,  
Clinical Research Specialist 
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Signature Date (DD-MMM-YYYY) 
 
Approver Name:  
Feng Tang 
Role or Title:  
Biostatistician,  
Sr. Statistics Manager 
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Signature Date (DD-MMM-YYYY) 
 
Approver Name:  
Cristina Faria 
Role or Title:  
Clinical Leadership,  
Clinical Research Manager Spinal and Biologics 
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Signature Date (DD-MMM-YYYY) 
 
Approver Name:  
Adrianna Matysek 
Role or Title:  
Clinical Quality/Compliance,  
Clinical Quality Specialist 
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Signature Date (DD/MMM/YYYY) 
 
 

 Clinical Study Document Approval Form 
 
Form 
 056-F154 
Revision  A 
Page 2 of 2 
 
 
This document is electronically controlled                 Medtronic Confidential    
 
Version 2.0 linked to CIP v2.0, 19 SEP 2018                      
 
 
Approver Name:  
Anton Bachinin 
Role or Title:  
Lead Monitor, 
Sr. Clinical Research Monitor 
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e-signature 
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Approver Name:  
Halina Limpens 
Role or Title:  
Regulatory, 
Sr. Regulatory Affairs Specialist 
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Approver Name:  
Alexander Cristea  
Role or Title:  
Therapy SME, 
Principal Medical Affairs Specialist 
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Approver Name:  
Carine van Deursen 
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Safety Representative, 
Safety Specialist 
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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  A Prospective, Multicenter Evaluation of the CD 
HORIZON® Fenestrated Screw Spinal System with 
Fenestrated Screw Cement When Used in the 
Treatment of Spinal Conditions in subjects with 
Compromised Bone Quality (FNS Study) 
Clinical Investigation Plan Identifier MDT17040SD1703 
Study Product Name 
x
CD HORIZON® Legacy™ Fenestrated Screw 
Spinal System 
x
CD HORIZON® Solera™ Fenestrated Screw 
Spinal System 
x
Fenestrated Screw Cement 
Sponsor Medtronic Bakken Research Center BV 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
Document Version 2.0 / 19 SEP 2018 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 
 
 

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1.Investigator Statement 
Study product Name 
CD HORIZON® Legacy™ Fenestrated Screw Spinal System 
CD HORIZON® Solera™ Fenestrated Screw Spinal System 
Fenestrated Screw Cement 
Sponsor 
Medtronic Bakken Research Center BV 
Clinical Investigation Plan Identifier 
MDT17040SD1703 
Version Number/Date  
2.0 / 19 SEP 2018 
I have read the protocol, including all appendices, and I agree that it contains all necessary details for 
me and my staff to conduct this study as described. I will conduct this study as outlined herein and 
will make a reasonable effort to complete the study within the time designated. 
I agree to comply with the applicable regulatory guidelines under which the study is being conducted, 
the ethical principles that have their origin in the Declaration of Helsinki 2013 and the clinical trial 
agreement. 
The study will be conducted in accordance with ISO14155:2011, and any regional or national 
regulations, as appropriate. 
I agree to ensure that the confidential information contained in this document will not be used for any 
purpose other than the evaluation and conduct of the clinical investigation without the prior written 
consent of Medtronic. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the products and the study. 
 
Investigator’s Signature: 
 
Investigator’s Name: 
 
Institution: 
 
Date:  
 
 
 

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Table of Contents  
 
 
1. 
Investigator Statement ...................................................................................................... 2 
Table of Contents ...................................................................................................................... 3 
2. 
Glossary .............................................................................................................................. 7 
3. 
Synopsis ............................................................................................................................. 8 
4. 
Introduction ..................................................................................................................... 14 
4.1 Background ............................................................................................................................. 14 
4.2 Purpose .................................................................................................................................. 16 
5. 
Objectives and Endpoints ................................................................................................. 16 
5.1 Objectives ............................................................................................................................... 16 
5.1.1 Primary Objective(s) ............................................................................................................. 16 
5.1.2 Secondary Objective(s) ......................................................................................................... 16 
5.2 Endpoints ................................................................................................................................ 17 
5.2.1 Primary Endpoint .................................................................................................................. 17 
5.2.2 Secondary Endpoints ............................................................................................................. 17 
6. 
Study Design .................................................................................................................... 18 
6.1 Duration.................................................................................................................................. 18 
6.2 Rationale................................................................................................................................. 19 
7. 
Product Description.......................................................................................................... 19 
7.1 General ................................................................................................................................... 19 
7.2 Dosage Form and Route of Administration ................................................................................ 21 
7.3 Manufacturer ........................................................................................................................... 21 
7.4 Packaging ............................................................................................................................... 21 
7.5 Intended Population ................................................................................................................ 21 
7.6 Product Use ............................................................................................................................ 22 
7.7 Product Training Requirements ................................................................................................. 22 
7.8 Product Receipt and Tracking ................................................................................................... 22 
7.9 Product Storage ....................................................................................................................... 22 

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7.10 Product Return ...................................................................................................................... 22 
7.11 Product Accountability ............................................................................................................ 23 
8. 
Selection of Subjects ........................................................................................................ 23 
8.1 Study Population ..................................................................................................................... 23 
8.2 Subject Enrollment .................................................................................................................. 23 
8.3 Inclusion Criteria ..................................................................................................................... 24 
8.4 Exclusion Criteria ..................................................................................................................... 24 
9. 
Study Procedures ............................................................................................................. 25 
9.1 Schedule of Events .................................................................................................................. 25 
9.1.1 Enrollment............................................................................................................................ 27 
9.1.2 Baseline ............................................................................................................................... 28 
9.1.3 Surgery ................................................................................................................................ 28 
9.1.4 Postoperative assessment prior to hospital discharge .............................................................. 29 
9.1.5 Postoperative assessment at 3 months (-1,5/+3 months), 12 months (±3 months) and 24 
months (±6 months) ..................................................................................................................... 29 
9.2 Subject Screening .................................................................................................................... 30 
9.3 Subject Consent ...................................................................................................................... 31 
9.4 Assessment of Effectiveness ..................................................................................................... 32 
9.4.1 Oswestry Disability Index (ODI) ............................................................................................. 32 
9.4.2 Back and Leg Pain (VAS) ....................................................................................................... 32 
9.4.3 EQ-5D 5L Questionnaire ........................................................................................................ 32 
9.4.4 Neurological status ............................................................................................................... 32 
9.4.5 Fusion Status (for those subjects where fusion is intended) ..................................................... 33 
9.4.6 Stabilization of the pedicle screw instrumentation ................................................................... 33 
9.4.7 Spinopelvic alignment ........................................................................................................... 34 
9.5 Assessment of Safety ............................................................................................................... 36 
9.5.1 Intraoperative cement extravasation/leakage ......................................................................... 36 
9.5.2 Device and/or procedure related adverse events ..................................................................... 37 
9.5.3 Secondary surgery at the index and/or adjacent level(s) throughout the study ......................... 37 
9.6 Imaging guidelines .................................................................................................................. 37 
9.7 Recording Data ........................................................................................................................ 37 

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9.8 Deviation Handling .................................................................................................................. 38 
9.8.1 Request for approval of study deviations ................................................................................ 39 
9.8.2 Reporting requirements for study deviations ........................................................................... 39 
9.8.3 Amendments to the Clinical Investigation Plan ........................................................................ 39 
9.9 Subject Withdrawal or Discontinuation ...................................................................................... 40 
10. Risks and Benefits ............................................................................................................ 41 
10.1 Potential Risks ....................................................................................................................... 41 
10.1.1 Risk of imaging/Radiation .................................................................................................... 41 
10.2 Potential Benefits ................................................................................................................... 42 
10.3 Risk-Benefit Rationale ............................................................................................................ 42 
11. Adverse Events and Device Deficiencies .......................................................................... 42 
11.1 Definitions/Classifications ....................................................................................................... 42 
11.2 Reporting of Adverse Events ................................................................................................... 47 
11.3 Not reportable events ............................................................................................................ 48 
11.4 Device Deficiencies ................................................................................................................ 49 
11.5 Reporting Adverse Events, Serious Adverse Events, Serious Adverse Device Effects, and Device 
Deficiencies to Medtronic ............................................................................................................... 49 
11.6 Deaths .................................................................................................................................. 49 
12. Data Review Committees ................................................................................................. 49 
13. Statistical Design and Methods ........................................................................................ 50 
13.1 Statistical Methods ................................................................................................................. 50 
13.2 Sample Size ........................................................................................................................... 51 
13.3 Analysis Dataset .................................................................................................................... 51 
13.4 Interim Analysis ..................................................................................................................... 51 
14. Ethics ................................................................................................................................ 51 
14.1 Statement(s) of Compliance ................................................................................................... 51 
14.2 Principal Investigator Obligation ............................................................................................. 52 
14.3 Reporting requirements .......................................................................................................... 53 
14.4 Oversight of Study Personnel .................................................................................................. 55 
14.5 Medtronic Representative Role................................................................................................ 56 
15. Study Administration ....................................................................................................... 56 

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15.1 Site activation ........................................................................................................................ 56 
15.2 Monitoring ............................................................................................................................. 57 
15.3 Data Management ................................................................................................................. 57 
15.4 Direct Access to Source Data/Documents ................................................................................ 58 
15.5 Confidentiality ....................................................................................................................... 58 
15.6 Liability ................................................................................................................................. 58 
15.7 CIP Amendments ................................................................................................................... 59 
15.8 Record Retention ................................................................................................................... 59 
15.9 Publication and Use of Information ......................................................................................... 59 
15.10 Suspension or Early Termination ........................................................................................... 60 
16. References ....................................................................................................................... 61 
17. Appendices ....................................................................................................................... 63 
17.1 Sponsor contact information ................................................................................................... 63 
17.2 Participating Investigators and Investigation Sites ................................................................... 63 
18. Version History ................................................................................................................. 63 
 
 
 

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2.Glossary 
Term 
Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
BMI 
Body Mass Index 
CIP 
Clinical Investigation Plan 
DD 
Device Deficiency 
DXA 
Dual-energy X-ray Absorptiometry 
eCRF 
Electronic Case Report Form 
EQ-5D 5L 
European Quality of Life-5 Dimensions; 5 Levels 
FNS 
Fenestrated Screws 
IFU 
Instructions for Use 
ODI 
Oswestry Disability Index 
PIC 
Patient Informed Consent 
PMMA 
Polymethylmethacrylate 
qCT 
quantitative Computed Tomography 
RC 
Research Coordinator 
RDC 
Remote Data Capture 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
VAS 
Visual Analog Scale 
 
 

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3.Synopsis 
Title: 
A Prospective, Multicenter Evaluation of the CD HORIZON® Fenestrated Screw 
Spinal System with Fenestrated Screw Cement When Used in the Treatment of 
Spinal Conditions in Subjects with Compromised Bone Quality (FNS Study)   
Clinical Study Type 
Post-market 
Study Product Name 
x
CD HORIZON® Legacy™ Fenestrated Screw Spinal System  
x
CD HORIZON® Solera™ Fenestrated Screw Spinal System 
x
Fenestrated Screw Cement 
Sponsor 
Medtronic Bakken Research Center BV 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
Indication under 
investigation 
Subjects with compromised bone quality requiring stabilization and/or 
immobilization of the thoracic and/or lumbar spine for one or more of the 
following diagnostic indications: 
x
Degenerative Spinal Disease (e.g. degenerative disc disease, 
spondylolisthesis and/or spinal stenosis)  
x
Deformity (e.g. degenerative deformity) 
Investigation purpose 
The purpose of this study is to evaluate outcomes in subjects with 
compromised bone quality diagnosed with one of the conditions described in 
the indications under investigation. This study is to confirm that the treated 
spinal segments can be safely and effectively immobilized and/or stabilized 
with cement-augmented posterior pedicle screw fixation. The study will 
evaluate clinical benefits and safety of the device.  
Product Status 
All devices used in this study are commercially available and will be used within 
the intended approved indication as listed in the Instructions for Use (IFU). 
Primary Objective 
To demonstrate that Oswestry disability index (ODI) score improved 
significantly at 12-months post-operatively as compared to baseline for each 

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indication (degenerative spinal disease and deformity) in subjects with 
compromised bone quality, who will receive a surgical procedure requiring 
posterior stabilization and/or immobilization of one or more spinal segments 
using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw 
Cement.  
Secondary Objectives 
Secondary objectives of this study include the assessment of the following 
endpoints for each indication (degenerative spinal disease and deformity): 
x
Improvement of ODI at 3- and 24-month visit from baseline. 
x
Improvement of VAS back and leg pain score at 3-, 12- and 24-month 
visit from baseline. 
x
Improvement of EQ-5D 5L at 3-, 12- and 24-month visit from baseline 
x
Neurological success at 12-month visit. 
x
Intraoperative cement extravasation/leakage. 
x
Device and/or procedure related adverse events through 24 months. 
x
Secondary spinal surgeries at index and/or adjacent level(s), resulting 
from an AE, up to 24 months after the surgery. 
x
Radiographic confirmation of stabilization of the pedicle screw 
instrumentation at 12-month visit. 
x
Radiographic fusion at 12-month visit for those subjects where fusion 
was intended. 
Secondary objective that is specifically for deformity subjects includes: 
x
Assessment of change in coronal and sagittal spinopelvic parameters 
from baseline at the 12-month visit. 
 
Study Design 
This is a multi-center, single arm, open-label, prospective study that will collect 
data on subjects with compromised bone quality undergoing thoracolumbar 
immobilization/stabilization surgery with CD HORIZON® Fenestrated Screw 
Spinal System, for degenerative spinal disease or deformity.   Clinical 
assessments will be completed at baseline (preoperatively), during surgery, 
prior to hospital discharge, and postoperatively at 3 months (-1,5/+ 3 months), 
12 months (± 3 months), and 24 months (± 6 months). Radiological 
assessments will be completed at baseline, prior to hospital discharge (for 
deformity subjects only in those sites where it is standard of care) and 

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postoperatively at 12 months. All subjects will be followed through the 24-
month visit. 
Sample Size 
Overall 100 subjects will be included with around 50 subjects (no less than 48 
subjects) in each indication group in approximately 10 sites in Europe. 
Inclusion/Exclusion 
Criteria 
Inclusion Criteria:  
A subject must meet the following inclusion criteria to participate in this trial: 
1. One or more of the following diagnostic indications:   
x
Degenerative Spinal Disease (e.g. degenerative disc disease, 
spondylolisthesis and/or spinal stenosis) 
x
Deformity (e.g. degenerative deformity) 
2. Degenerative Spinal Disease patients only: Patient has been 
unresponsive to non-operative treatment for at least three months or 
has progressive symptoms or signs of nerve root/spinal cord 
compression 
while 
undergoing 
continued 
non-operative 
management. 
3. Compromised bone quality defined as a hip DXA scan T-score less than 
or equal to -1.0 or spine quantitative CT (qCT) actual volumetric bone 
mineral density threshold of ≤ 120 mg/cm3. 
4. Requires a procedure with an instrumented, posterior thoracic and/or 
lumbar spinal stabilization and/or immobilization.  
5. Is scheduled to receive a construct using CD Horizon® Spinal System 
components with at least one Fenestrated Screw cemented with 
Fenestrated Screw Cement. 
6. At least 22 years old or greater at the time of informed consent. 
7. Is able to understand and willing to sign the Patient Informed Consent 
Form. 
8. Is willing and able to undergo the study procedure and perform the 
follow up visits.  
 
Exclusion criteria: 

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A subject will be excluded from participating in this trial for any of the following 
reasons: 
x
Has undergone stabilization and/or fusion procedure at the index or 
adjacent levels. 
x
Will undergo vertebroplasty or kyphoplasty procedure during surgery. 
x
Has been diagnosed with cauda equina syndrome. 
x
Has been previously diagnosed with clinically significant peripheral 
neuropathy. 
x
Has any degree of permanent neurologic deficit due to the presenting 
spinal disease (e.g. drop foot or gait deficit). 
x
Has obesity defined by BMI greater than or equal to 35kg/m2. 
x
Has documented allergy to the materials that will be used in the 
surgical or any imaging procedure (e.g. titanium alloys, cobalt-
chromium-molybdenum alloys, PMMA Fenestrated Screw Cement, 
contrast medium). 
x
Has overt or active bacterial infection, local or systemic, and/or 
potential for bacteremia. 
x
Has a non-correctable spontaneous or therapeutic coagulation 
disorder or history of coagulation disorder associated with bleeding. 
x
Has evolutive cardiac disease (e.g. symptomatic congestive heart 
failure, unstable angina pectoris, cardiac arrhythmia) nonreactive to 
medical treatment. 
x
Has any disease (e.g., neuromuscular disease, etc.) that would 
preclude the potential benefit and/or accurate clinical evaluation of 
the safety of the spinal implant surgery. 
x
Is pregnant or planning to become pregnant during the study duration. 
x
Is illiterate or considered vulnerable as per the Investigator’s 
assessment (e.g., participants incapable of judgment, or participants 
under tutelage). 

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x
Concurrent participation in another clinical study that may add 
additional safety risks and/or confound study results*. 
*Subjects in concurrent studies can only be enrolled with permission from 
Medtronic. Please contact Medtronic’s study manager to determine if the 
subject can be enrolled in the FNS Study. 
 
Outcomes 
Endpoints 
Measurements 
Primary Endpoint 
Improvement of ODI from baseline at 
12-month visit. 
Oswestry Disability Index (ODI) 
Secondary Endpoints 
Secondary 
clinical 
outcomes 
including: 
Improvement of ODI from baseline   at 
3- and 24-month visit. 
Improvement of VAS back and leg 
pain score from baseline at 3-, 12- and 
24-month visit. 
Improvement of EQ-5D 5L from 
baseline at 3-, 12- and 24-month visit. 
 
ODI 
 
VAS back and leg pain score 
 
EQ-5D 5L 
Neurological success at 12-month 
visit. 
Physician Reported 
Intraoperative 
cement 
extravasation/leakage. 
Physician Reported 
Device and/or procedure related 
adverse events through 24 months. 
Adverse Event Reporting 
Secondary spinal surgeries at index 
and/or adjacent level(s), resulting 
from an AE, up to 24 months after the 
surgery. 
Adverse Event Reporting 

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Radiographic 
confirmation 
of 
stabilization of the pedicle screw 
instrumentation at 12-month visit. 
Physician assessed radiographic images 
Radiographic Fusion at 12-month visit 
for those subjects where fusion was 
intended. 
Physician assessed radiographic images 
Secondary Endpoints 
for Deformity subjects 
 
Change in coronal and sagittal 
spinopelvic parameters from baseline 
at 12-month visit. 
 
Physician assessed radiographic images 
Statistical Methods: 
For the primary endpoint improvement of ODI score from baseline at 12-
month visit, in addition to the descriptive statistics including mean, standard 
deviations, minimum and maximum, a paired t-test for normally distributed 
data or Wilcoxon signed rank test for not normally distributed data will be 
carried out to test whether the mean improvement from baseline is 
significantly greater than 0 for each indication subgroup.   
If P-value is ≤ 0.05, then primary objective is met. Similar method will be used 
for the secondary clinical outcomes including improvement of ODI from 
baseline at 3- and 24-month visit, improvement of VAS back and leg pain score 
from baseline at 3-, 12- and 24-month visit and improvement of EQ-5D 5L from 
baseline at 3-, 12- and 24-month visit. For the secondary endpoints including 
neurological 
success 
at 
12-month 
visit, 
intraoperative 
cement 
extravasation/leakage, pedicle screw instrumentation stabilization at 12-
month visit and fusion success at 12-month visit, simple frequencies will be 
summarized.  As for secondary endpoints including device and/or procedure 
related adverse events through 24 months and secondary spinal surgeries at 
index and/or adjacent level(s), resulting from an AE, up to 24 months after the 
surgery, the event rate will be estimated using time-to-event analysis. 
All the analyses will be done separately for each indication subgroup. For the 
deformity group, the secondary endpoints, change in coronal and sagittal 
spinopelvic parameters from baseline at 12-month visit, will be analyzed using 
the same method as the one for the primary endpoint. 

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4.Introduction  
4.1 Background  
Posterior stabilization and immobilization of thoracolumbar spinal segments with pedicle screw and rod 
systems is dependent on the anchor strength of pedicle screws within the vertebrae. One of the 
determining factors for pedicle screw fixation is the quality of the bone within the vertebral bodies [1, 2].  
It’s estimated that 50% and 15% of female and male spine subjects respectively, older than 50 years, have 
osteoporosis [3]. Complications resulting from the use of pedicle screws in compromised bone may 
include screw loosening, screw pullout and/or complete hardware failure due to the poor fixation strength 
of the screws within the vertebrae. Therefore, strategies to ensure adequate anchorage of the pedicle 
screws within the vertebrae are necessary to treat these subjects.   
Biomechanical studies have demonstrated that the use of bone cement-augmented pedicle screw fixation 
results in significantly increased holding power of screws in osteoporotic spine [4, 5]. As a result, clinical 
techniques have been developed whereby bone cement, such as polymethylmethacrylate (PMMA) is 
injected into the vertebral bodies, and when cured serves as the screw interface providing adequate 
pedicle screw fixation. 
There are two techniques by which surgeons augment pedicle screw fixation using bone cement. One 
technique is to create a channel in the pedicle where the pedicle screw will be inserted. Bone cement is 
first injected into the vertebral body through the channel followed by placement of the pedicle screws 
[6]. This technique increases the fixation strength of the pedicle screws [7] but is associated with 
additional risks [8, 9].    
The second technique is to use a cannulated pedicle screw that has fenestrations or openings in the distal 
end of the screw. Fenestrated screws (FNS) are inserted into the vertebral body first, and bone cement is 
then injected through the screw cannula and extruded through the fenestrations into the cancellous bone 
of the vertebral body. This method also demonstrated increased fixation strength of the pedicle screws 
[10] as well as decreased cement leakage [11]. 
The primary safety risks associated with pedicle screw augmentation are the risks associated with cement 
extravasation either via the intervertebral vasculature, or perivertebrally through breaches in the cortical 
shell. Although most cement leakages are asymptomatic [11-15], there are reports of clinically relevant 
leakages [8, 16]. Two widely accepted procedures that introduce cement into vertebral bodies at 
considerably higher volumes than FNS are kyphoplasty (KP) and vertebroplasty (VP).  In these procedures, 
cement leakage has been reported from 11.3% [17] to 87.5% [18].  
Reports of cement extravasation in PMMA-augmented fenestrated pedicle screw fixation range from 5.7% 
to 29.3% [13, 14].  
The factors associated with the reduced extravasation rate and reduced volume of extravasation per 
occurrence with FNS is due to the controlled delivery of a lower volume of cement under fluoroscopic 
imaging that provides immediate feedback and allows precise control of the cement delivery.    

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There are several clinical reports of FNS use in the literature. Amendola et al. [19], reported on 21 subjects 
with poor bone quality due to osteoporosis or tumor that underwent posterior stabilization by fenestrated 
pedicle screws and PMMA augmentation. Pain improvement and long-term clinical outcome were 
assessed by visual analogue scale (VAS) and SF-36 health survey (SF-36) questionnaire. Complications 
were evaluated in all cases. VAS-pain scores and SF-36 questionnaires showed a statistically significant 
reduction in pain and improvement in the quality of life during the 36 months’ follow-up period. No screw 
loosening or screw pullout was observed. In two cases, cement leakage occurred intraoperatively: of 
these, one subject had transitory nerve root palsy, which improved spontaneously when the excess 
cement was removed by the surgeon. In three cases, the post-op CT scan revealed a small amount of 
cement in the canal without clinical relevance. Lubansu et al. [12] described a percutaneous or minimally 
invasive approach for augmentation of FNS. The safety and effectiveness of this technique was evaluated 
in 15 elderly osteoporotic subjects (mean T score = -2.7, range = -2.1 to -4.1). Clinical outcomes were 
assessed using the Visual Analogue Scale (VAS) score and the Oswestry Disability Index (ODI). Both the 
VAS-pain scores and ODI questionnaires showed a statistically significant improvement up to 13.3 months 
postoperatively. PMMA asymptomatic extravasations were observed in 5/15 subjects. There were no 
cases of severe morbidity post-operatively (no death, no myocardial infarction, no pulmonary emboli, or 
intraoperative hypotension). Two postoperative complications related to the procedure were noted: one 
S1 screw misplacement associated with nerve radiculitis (no cement injected through this screw), and one 
subcutaneous infection that was treated with 2 weeks of antibiotic therapy. During the follow-up period, 
no construct failures, screw fractures, screw pullouts or loss of correction were noted. In another study 
[14], 37 subjects with degenerative spinal stenosis and osteoporosis (T-score <-2.5) were evaluated after 
placement of PMMA augmented cannulated pedicle screws. The clinical outcome measurements included 
the VAS-pain score and the Prolo scale. The postoperative VAS score for low back pain and leg pain (2.30 
± 1.61 and 1.42 ± 0.73) improved significantly (p = 0.006, p = 0.003) from preoperative VAS scores (7.87 ± 
0.95 and 8.82 ± 0.83). The average postoperative Prolo score (7.76 ± 1.74) improved significantly (p = 0.01) 
from the preoperative score (4.22 ± 0.95). There were no screw fractures or construct failures. Pedicle 
screw loosening was observed in one subject (2.7%). Local extravasations of PMMA into the ventral aspect 
of the vertebral body were observed in two cases (5.4%). There were no pulmonary emboli or cases of 
osteomyelitis.  
Pinera et al. [13] studied 23 elderly subjects with lumbar degenerative spondylolisthesis with instability, 
or lumbar stenosis requiring aggressive decompression, that underwent a spinal fusion with PMMA-
augmented cannulated pedicle screw instrumentation. All subjects had a history of osteoporotic fractures 
or had bone mineral density T-scores that indicated osteoporosis (mean T score was -2.4; range -1.8 to -
4.1). The results showed that pain and functions improved at 6 months and were maintained over a time. 
There were no reports of screw pullout or instrumentation failure. There were no cases of adjacent 
vertebral fractures. Cement leakage was observed in 29.3% of the treated vertebrae; however, no clinical 
complications secondary to PMMA leakage were reported.  
CD HORIZON® Fenestrated Screw Spinal System has been CE-marked since 2011 and received 510(k) 
clearance in January 2016. Chandra et al. [20] reported on 25 osteoporotic subjects (average T-score -3.0)  
with up to grade III spondylolisthesis that were treated with the CD HORIZON® Fenestrated Screw Spinal 
System. The subject group experienced significant improvement in pain (VAS) and disability (ODI) from 

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pre-op to final post-op evaluation (mean follow-up, 18 months).  In this study, there was one event of 
cement extravasation with no adverse clinical sequelae. There were no reports of screw pull out or 
instrumentation failure. 
Medtronic is proposing this post-market study to evaluate clinical benefits and safety of CD HORIZON® 
Fenestrated Screw Spinal System with Fenestrated Screw Cement for stabilization and immobilization of 
spinal segments in subjects with compromised bone quality.  
4.2 Purpose 
The purpose of the post-market study is to evaluate the clinical benefit and safety of CD HORIZON® 
Fenestrated Screw Spinal System with Fenestrated Screw Cement when used in subjects with 
compromised bone quality undergoing a thoracolumbar procedure requiring posterior immobilization 
and/or stabilization of one or more spinal segments. The data obtained from this study may be used for 
regulatory purposes worldwide, including supporting a 510(k) application for expanded indications in the 
US, in addition to possible publications.      
5.Objectives and Endpoints 
5.1 Objectives 
5.1.1 Primary Objective(s) 
The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) 
score improved significantly at 12 months post-operatively as compared to baseline for each indication 
(degenerative spinal disease and deformity) in subjects with compromised bone quality, who will receive 
a surgical procedure requiring posterior stabilization and/or immobilization of one or more spinal 
segments using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement. 
5.1.2 Secondary Objective(s)  
Secondary objectives of this study include the assessment of the following endpoints for each indication 
(degenerative spinal disease and deformity): 
x
Improvement of ODI at 3- and 24-month visit from baseline. 
x
Improvement of VAS back and leg pain score at 3-, 12- and 24-month visit from baseline. 
x
Improvement of EQ-5D 5L at 3-, 12- and 24-month visit from baseline. 
x
Neurological success at 12-month visit. 
x
Intraoperative cement extravasation/leakage. 

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x
Device and/or procedure related adverse events through 24 months. 
x
Secondary spinal surgeries at index and/or adjacent level(s), resulting from an AE, up to 24 months 
after the surgery. 
x
Radiographic confirmation of stabilization of the pedicle screw instrumentation at 12-month visit. 
x
Radiographic fusion at 12-month visit for those subjects where fusion was intended. 
 
Secondary objective that is specifically for deformity subjects includes: 
x
Assessment of change in coronal and sagittal spinopelvic parameters from baseline at the 12-
month visit. 
5.2 Endpoints 
5.2.1 Primary Endpoint 
The primary endpoint is the improvement in ODI at 12 months compared to baseline. 
5.2.2 Secondary Endpoints 
The secondary endpoints are: 
x
Improvement of ODI from baseline at 3- and 24-month visit. 
x
Improvement of VAS back and leg pain score from baseline at 3-, 12- and 24-month visit. 
x
Improvement of EQ-5D 5L from baseline at 3-, 12- and 24-month visit. 
x
Neurological success at 12-month visit. 
x
Intraoperative cement extravasation/leakage. 
x
Device and/or procedure related adverse events through 24-months. 
x
Secondary spinal surgeries at index and/or adjacent level(s), resulting from an AE, up to 24 months 
after the surgery. 
x
Radiographic evaluation of pedicle screw instrumentation stabilization at 12-month visit. 
x
Radiographic evaluation of fusion status at 12-month visit for those subjects where fusion was 
intended.  
Secondary endpoint to be assessed specifically for deformity subjects includes: 

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x
Change in coronal and sagittal spinopelvic parameters from baseline at the 12-month visit.  
6.Study Design  
This is a multi-center, single arm, open-label, prospective study that will collect data on subjects with 
compromised bone quality undergoing thoracolumbar immobilization/stabilization surgery using CD 
HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement, for degenerative spinal 
disease or deformity.    
The study will evaluate overall 100 subjects with around 50 subjects (no less than 48 subjects) in each 
indication subgroup at approximately 10 study sites in Europe. A minimum of 1 subject and a maximum 
of 25 subjects will be included per site. For each site, no more than approximately 15 patients are allowed 
to be included per subgroup (degenerative spinal disease, deformity). These limits may be subject to 
change during the course of the study and will be communicated as appropriate to the Investigators, 
EC/IRB and regulatory authority, if required.  
Commercially available study devices will be used in accordance with the instructions as listed in the IFUs 
applicable in each country. 
Only consented subjects can be enrolled into the study. Every effort will be made to enroll subjects in a 
consecutive manner. Clinical assessments will be completed at baseline (preoperatively), during the 
procedure, prior to hospital discharge, and postoperatively at 3 months, 12 months, and 24 months.  
Radiological assessments will be completed at baseline, prior to hospital discharge (only for deformity 
subjects if standard of care at the site) and postoperatively at 12 months. All subjects will be followed 
through the 24-month visit. 
6.1 Duration 
Enrollment in the study for each subject is defined as the date the subject first signs the informed consent.    
Enrolled subjects who do not meet baseline eligibility or who do not undergo the fenestrated screw 
procedure as defined in this protocol will be exited from the study but can be replaced if enrollment is 
still open. The completion of the study for each subject is defined as the conclusion of the 24-month visit 
(Study Exit). Each subject’s participation in the study is expected to last approximately 2 years from the 
date of the procedure. Each subject will be evaluated prior to the procedure (baseline), during the 
procedure, prior to hospital discharge, 3 months, 12 months, and 24 months post procedure. 
The estimated time needed to enroll all subjects is approximately 2 years. The overall study duration, from 
first subject enrollment to last subject visit, is expected to last approximately 4 years. The completion of 
the study is defined as the approval of the Final Study Report and closure of all sites. It is anticipated that 
the total duration of this study will be approximately 4.5 years.   

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6.2 Rationale  
CD HORIZON® Fenestrated Screw Spinal System has been CE-marked since 2011, for the treatment of 
degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc 
confirmed by history and radiographic studies), ankylosing spondylitis, spondylolisthesis, trauma (fracture 
or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis or lordosis), tumor, pseudoarthrosis, 
revision surgery and/or failed previous fusion.   
The CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement is designed to 
enhance the fixation strength of instrumentation in vertebrae with compromised bone quality.  Currently, 
in the US, these screws with Fenestrated Screw Cement are 510(k) cleared only for the treatment of 
advance stage tumor subjects.  However, within the US, nearly 50% of the population of subjects requiring 
spinal immobilization/stabilization procedures for degenerative disc disease, spondylolisthesis, trauma 
(fracture or dislocation), or spinal stenosis, also have compromised bone quality.  Outside of the United 
States, the CD HORIZON® Fenestrated Screw Spinal System is CE-marked for broader indications and is 
being used to treat subjects with compromised bone quality.  The proposed study design provides an 
opportunity to collect real-world clinical and radiographic data for CD HORIZON® Fenestrated Screw Spinal 
System with Fenestrated Screw Cement when used for the treatment of degenerative spinal disease or 
deformity. 
The proposed primary endpoint at 12 months is sufficient to demonstrate improvement in disability (ODI).  
Furthermore, literature [21, 22] and previous Medtronic sponsored studies have demonstrated that 
subject reported outcomes at 12 months are consistent with outcomes reported at longer follow-up 
intervals. To confirm this, we will also be collecting patient reported clinical outcomes at 24 months.  In 
addition, the proposed radiographic evaluation of the pedicle screws at 12 months is sufficient time to 
reveal any apparent evidence of implant loosening.      
To assess long-term safety of the device, subjects will be followed-up for 24 months to collect safety 
information.  
7.Product Description 
7.1 General 
The figure below shows the CD HORIZON® Legacy™ and Solera™ Fenestrated Screw 
 
Figure 1: CD HORIZON® Legacy™(left) and Solera™(right) Fenestrated Screw 
 

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The CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of 
cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement 
(Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used 
to augment screw fixation in subjects with compromised bone quality.  
The CD HORIZON® Legacy™ Fenestrated Screws are specifically designed to connect to Ø 5.5mm rods and 
associated components contained within the CD HORIZON® Spinal System. The CD HORIZON® Solera™ 
Fenestrated Screws are specifically designed to connect to rods of Ø 4.75, 5.5 and 6.0mm and associated 
components contained within the CD HORIZON® Spinal System. 
The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, plates, and other connecting 
components used to build a spinal construct. The entire spinal construct must contain CD Horizon® Spinal 
System components with at least one Fenestrated Screw cemented with Fenestrated Screw Cement. 
Instrumentation is also available to facilitate implantation of these components. Additionally, other 
commercially available ancillary devices, implants, instrumentation and bone grafts/substitutes can be 
used during the surgery procedure. 
All devices used in this study, shall be used within their intended use as described in the Instructions for 
Use for which CE mark has been obtained. Labeling of the devices will be in the appropriate local language. 
It is an investigator’s responsibility to only use commercially available devices within intended use in the 
scope of this study. 
 
The CD Horizon® Legacy™ Fenestrated Screws are fabricated from medical-grade titanium and/or medical 
grade titanium alloy.  The CD HORIZON® Solera™ Fenestrated Screws are fabricated from medical-grade 
titanium and/or medical grade titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy.  
Fenestrated Screw Cement (Reference Number 7480724) is a polymethylmethacrylate (PMMA) that 
contains approximately 30% barium sulfate.  
 
Nominal Composition of Fenestrated Screw Cement (Reference Number 7480724): 
(Actual weight percentages of individual components will vary within accepted ranges)
 
The CD Horizon® Legacy™ and Solera™ Fenestrated Screws and the Fenestrated Screw Cement do not 
incorporate, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex 
I (93/42/EEC). 
For the manufacturing of the CD HORIZON® Legacy™ and Solera™ Fenestrated Screw and the Fenestrated 
Screw Cement no tissues of animal origin as referred to in Directive 2003/32/EC were used. 

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7.2 Dosage Form and Route of Administration 
The operating surgeon should refer to the Instructions for Use (IFU) for the CD Horizon® Legacy™ and 
Solera™ Fenestrated Screws and the Fenestrated Screw cement for Warnings, Precautions, and Operative 
Steps on the usage of the products. The recommended amount of cement to be injected is also specified 
in the IFU.   
7.3 Manufacturer 
CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System: 
Medtronic Humacao 
PR-909 
Humacao 00791 
Puerto Rico  
Fenestrated Screw Cement: 
TECRES S.p.A 
Via A. Doria 6 
37066 Sommacampagna 
Verona - Italy  
7.4 Packaging 
The CD HORIZON® Fenestrated Screw Spinal System is provided in a set and must be sterilized by the 
hospital prior to use. The product can be steam-sterilized using process parameters listed in the indication 
for use.  
The Fenestrated Screw Cement is provided sterile and is intended for single use only. The powder and 
package are sterilized with gamma radiation. The liquid is sterilized using filtration and is contained in a 
glass vial. The outside of the glass vial is sterilized with ethylene oxide gas. Once the seal on the sterile 
package has been broken, the product should not be re-sterilized or reused. Labelling is specific to the 
geography and in accordance with local regulations. 
7.5 Intended Population 
The CD HORIZON® Fenestrated Screws, when used in conjunction with Fenestrated Screw Cement are 
intended to provide enhanced pedicular fixation in the treatment of subjects with compromised bone 
quality for the following indications:  
CD HORIZON® Legacy™ Fenestrated Screw Spinal System: degenerative disc disease (defined as back pain 
of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 
ankylosing spondylitis, spondylolisthesis, trauma (i.e. fracture and/or dislocation), spinal stenosis, failed 

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previous fusion (pseudoarthrosis), deformity (e.g. adult degenerative deformity, scoliosis, kyphosis, 
lordosis), revision surgery, and/or tumor. 
CD HORIZON® Solera™ Fenestrated Screw Spinal System:  degenerative disc disease (defined as back pain 
of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 
spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, 
or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. 
7.6 Product Use 
The CD HORIZON® Legacy™ Fenestrated Screw Spinal System, the CD HORIZON® Solera™ Fenestrated 
Screw Spinal System, and the Fenestrated Screw Cement will be used according to the surgical techniques 
described in the CD HORIZON® Fenestrated Screw Spinal System Surgical Technique Brochures. The 
operating surgeon should refer to the respective products’ IFU for any corresponding product information 
prior to using the product.  
7.7 Product Training Requirements 
The Investigator shall be experienced in the field of application and trained in the use of the study 
device(s), and qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation.  Investigator qualifications will be verified by Curriculum Vitae (CV), 
and during Site Qualification Visits (SQVs), if applicable. 
7.8 Product Receipt and Tracking 
This is a post-market study and the CD HORIZON® Legacy™ Fenestrated Screw Spinal System, CD 
HORIZON® Solera™ Fenestrated Screw Spinal System, and the Fenestrated Screw Cement used during the 
study are commercially available. Product receipt and tracking is not required as the devices used during 
the study are purchased through normal commercial channels. 
7.9 Product Storage 
Products should be stored per the institutions’ standard procedures.  
7.10 Product Return 
Products should be disposed of or returned per the institutions’ standard procedures. 

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7.11 Product Accountability  
Product accountability is not required for this post-market study as the devices used during the study are 
purchased through normal commercial channels and maintained per the institutions’ standard 
procedures.  
8.Selection of Subjects 
8.1 Study Population 
The study population are subjects with compromised bone quality seeking treatment at a participating 
study center for one or more of the following conditions: 
x
Degenerative Spinal Disease (e.g. degenerative disc disease, spondylolisthesis and/or spinal 
stenosis) 
x
Deformity (e.g. degenerative deformity) 
Participating centers will be instructed to consecutively screen all subjects who are planned to undergo a 
procedure with an instrumented, posterior thoracic and/or lumbar spinal stabilization/immobilization 
using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement against the 
eligibility criteria. Every effort will be made to enroll subjects in a consecutive manner.  
Overall 100 subjects, with around 50 subjects (no less than 48 subjects) in each indication subgroup, that 
meet eligibility and provide written informed consent will be enrolled into this study. Subjects will be 
enrolled in approximately 10 centers in Europe. 
The enrollment limit has been defined to be 50 patients per indication (degenerative spinal disease or 
deformity). Investigators will be requested to stop enrollment for a particular indication when the 
maximum enrollment (50 patients) for that indication has been reached.  
A minimum of 1 subject and a maximum of 25 subjects will be included per site. For each site, no more 
than approximately 15 patients are allowed to be included per subgroup (degenerative spinal disease, 
deformity). These limits may be subject to change during the course of the study and will be 
communicated as appropriate to the Investigators, EC/IRB and regulatory authority, if required. 
8.2 Subject Enrollment 
Subjects planning to undergo a procedure with an instrumented, posterior thoracic and/or lumbar spinal 
stabilization/immobilization using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated 
Screw Cement will be screened for eligibility to participate in the study. Subjects will be considered 
enrolled in the study once the informed consent form is signed; however, those who do not meet the 

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baseline inclusion/exclusion criteria or who do not undergo the fenestrated screw procedure as defined 
in this protocol will be exited from the study but can be replaced if enrollment is still open. 
8.3 Inclusion Criteria 
A subject must meet the following inclusion criteria to participate in this trial: 
1. One or more of the following diagnostic indications:  
x
Degenerative Spinal Disease (e.g. degenerative disc disease, spondylolisthesis and/or 
spinal stenosis) 
x
Deformity (e.g. degenerative deformity) 
2. Degenerative Spinal Disease patients only: Patient has been unresponsive to non-operative 
treatment for at least three months or has progressive symptoms or signs of nerve root/spinal 
cord compression while undergoing continued non-operative management. 
3. Compromised bone quality defined as a hip DXA scan T-score less than or equal to -1.0 or spine 
quantitative CT (qCT) actual volumetric bone mineral density threshold of ≤ 120 mg/cm3.  
4. Requires a procedure with an instrumented, posterior thoracic and/or lumbar spinal stabilization 
and/or immobilization. 
5. Is scheduled to receive a construct using CD Horizon® Spinal System components with at least one 
Fenestrated Screw cemented with Fenestrated Screw Cement. 
6. At least 22 years old or greater at the time of informed consent. 
7. Is able to understand and willing to sign the Patient Informed Consent Form. 
8. Is willing and able to undergo the study procedure and perform the follow up visits.  
8.4 Exclusion Criteria 
A subject will be excluded from participating in this trial for any of the following reasons: 
1. Has undergone stabilization and/or fusion procedure at the index or adjacent levels. 
2. Will undergo vertebroplasty or kyphoplasty procedure during surgery.  
3. Has been diagnosed with cauda equina syndrome. 
4. Has been previously diagnosed with clinically significant peripheral neuropathy. 

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5. Has any degree of permanent neurologic deficit due to the presenting spinal disease (e.g. drop 
foot or gait deficit). 
6. Has obesity defined by BMI greater than or equal to 35kg/m2. 
7. Has documented allergy to the materials that will be used in the surgical or any imaging procedure 
(e.g. titanium alloys, cobalt-chromium-molybdenum alloys, PMMA Fenestrated Screw Cement, 
contrast medium) 
8. Has overt or active bacterial infection, local or systemic, and/or potential for bacteremia. 
9. Has a non-correctable spontaneous or therapeutic coagulation disorder or history of coagulation 
disorder associated with bleeding. 
10.Has evolutive cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, 
cardiac arrhythmia) nonreactive to medical treatment. 
11.Has any disease (e.g., neuromuscular disease, etc.) that would preclude the potential benefit 
and/or accurate clinical evaluation of the safety of the spinal implant surgery. 
12.Is pregnant or planning to become pregnant during the study duration. 
13.Is illiterate or considered vulnerable as per the Investigator’s assessment (e.g., participants 
incapable of judgment, or participants under tutelage). 
14.Concurrent participation in another clinical study that may add additional safety risks and/or 
confound study results*. 
*Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact 
Medtronic’s study manager to determine if the subject can be enrolled in the FNS Study. 
9.Study Procedures  
9.1 Schedule of Events 
The study schedule, procedures, and methods of assessment are defined in detail to enable compliance 
with the required activities, and to ensure that the resulting data meet the criteria for evaluability. See 
Table 9-1 for visit schedule. The relevant electronic Case Report Forms (eCRFs) along with the applicable 
source documentation will be completed for each subject. 
 

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Table 9-1: Schedule of Events 
 
Enrollment / 
Baseline 
Surgery1 
Prior to discharge 
3 months  
(-1,5 / +3 months) 
12 months  
(±3 months) 
24 months  
(±6 months) 
Informed consent 
X2 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
Hip DXA scan or spine qCT 
X3 
 
 
 
 
 
Surgery Indication 
X 
 
 
 
 
 
Surgery 
 
X 
 
 
 
 
Intraoperative cement extravasation/leakage 
 
X 
 
 
 
 
X-ray or CT scan 
 
 
(X) 4 
 
X 
(X)5 
                                                          
1 The surgery procedure should occur as soon as possible after baseline but no later than 6 months after the date of 
acquiring the X-ray, MRI and/or CT-scan images.However, if the surgery cannot be done within 6 months after the 
date of the images then new images should be obtained. 
2 Patient Informed Consent must be obtained prior to performing any study specific procedure. 
3 Hip DEXA scan or spine qCT can be collected prior to enrollment/baseline visit if this is part of the standard of care 
and if it is not older than 3 months before the baseline visit. If not standard of care at the site, this is considered a 
study procedure and Patient Informed Consent must be obtained first.  
4 It is at the Investigator’s discretion to do a post-operative CT to assess pulmonary embolism in case there is a 
possibility for cement extravasation/leakage. 
5 CT-scan or X-rays is required at 12 months follow-up for assessment of fusion (for those subjects where fusion is 
intended) and confirmation of stabilization of the pedicle screw instrumentation. If no fusion is observed at 1-year 
follow-up, it will be at the discretion of the Investigator to follow-up if fusion can be observed at 24 months (only if 
standard of care at the site). In case the patient is symptomatic at 24 months and receives a CT-scan or X-ray, 
stabilization of pedicle screw instrumentation and fusion status (for those subjects where fusion is intended) will be 
assessed. 
 

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Enrollment / 
Baseline 
Surgery1 
Prior to discharge 
3 months  
(-1,5 / +3 months) 
12 months  
(±3 months) 
24 months  
(±6 months) 
Spinopelvic alignment6 
X 
 
(X)7 
 
X 
(X)8 
Medication 
X 
 
X 
X 
X 
X 
Neurological status 
X 
 
 
 
X 
 
VAS (back and leg pain) 
X 
 
 
X 
X 
X 
ODI 
X 
 
 
X 
X 
X 
EQ-5D 5L 
X 
 
 
X 
X 
X 
Adverse Events and/or device deficiencies 
 
X 
X 
X 
X 
X 
Protocol Deviations 
X 
X 
X 
X 
X 
X 
9.1.1 Enrollment 
All subjects must give their informed consent in accordance with the informed consent regulations per 
geographic region. At this visit, the following is a list of likely procedures: 
x
The subject will be presented with information about the clinical study and asked if he/she would 
like to participate 
x
The subject will be evaluated for eligibility per the inclusion/exclusion criteria. 
If the subject meets the eligibility criteria and agrees to participate in the study, he/she will be asked to 
sign the patient informed consent (PIC). Once the PIC is signed, a copy of the signed PIC will be provided 
to the subject. 
All subjects must sign the PIC prior to the collection of any study data. A subject is considered enrolled in 
this study at the time he/she signs the PIC. The subject will be assigned a unique, sequential code linked 
                                                          
6 Spinopelvic alignment parameters are only required to be assessed for deformity subjects. 
7 Spinopelvic alignment parameters will only be collected prior to discharge in those sites where it is standard of 
care. 
8 In case the patient is symptomatic at 24 months and receives a standing, frontal and sagittal full spine X-ray (at 
least C7 + femoral head must be visible), spinopelvic parameters will be assessed.  

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to their name, alternative subject identification or contact information. The Investigator will maintain a 
log of all subjects enrolled in the study.  
The enrollment limit has been defined to be 50 patients per indication (degenerative spinal disease or 
deformity). Investigators will be requested to stop enrollment for a particular indication when the 
maximum enrollment (50 patients) for that indication has been reached.  A minimum of 1 subject and a 
maximum of 25 subjects will be included per site. For each site, no more than approximately 15 patients 
are allowed to be included per subgroup (degenerative spinal disease, deformity). These limits may be 
subject to change during the course of the study and will be communicated as appropriate to the 
Investigators, EC/IRB and regulatory authority, if required. 
9.1.2 Baseline 
The following information will be collected at the baseline visit: 
x
Verification of Inclusion/Exclusion criteria 
x
Demographics 
x
Medical History 
x
Hip DXA scan or spine qCT (can be collected prior to baseline visit if this is part of the standard of 
care and if it is not older than 3 months before the baseline visit) 
x
Surgery Indication 
x
Imaging (X-ray, MRI and/or CT-scan) (can be collected prior to baseline visit if it is not older than 
6 months before surgery date) 
x
Spinopelvic alignment parameters (only required for deformity subjects) 
x
Medication 
x
Neurological status 
x
VAS back and leg pain 
x
ODI 
x
EQ-5D 5L 
x
Protocol Deviations 
9.1.3 Surgery  
The surgery procedure should occur as soon as possible after baseline but no later than 6 months after 
the date of acquiring the X-ray, MRI and/or CT-scan images. However, if the surgery cannot be done within 
6 months after the date of the images then new images should be obtained. 
The following information will be collected during surgery: 
x
Surgery procedure data 

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x
Surgery time 
x
Blood loss and Transfusion 
x
Intraoperative cement extravasation/leakage 
x
Device Models 
x
Adverse Events and/or device deficiencies 
x
Protocol Deviations 
It is recognized that the situation of a subject might change after enrollment. Due to Investigator’s 
discretion, a subject might not receive at least one Fenestrated Screw cemented with Fenestrated Screw 
Cement during the procedure. If this situation occurs this shall be documented on a study deviation eCRF, 
including rationale for change in procedure and the study early termination form will be completed in the 
eCRF. 
9.1.4 Postoperative assessment prior to hospital discharge 
The following information will be collected prior to hospital discharge: 
x
Spinopelvic alignment parameters (only required for deformity subjects in those sites where it is 
standard of care) 
x
Medication 
x
Adverse Events and/or device deficiencies 
x
Protocol Deviations 
It is at the Investigator’s discretion to do a post-operative CT to assess pulmonary embolism in case there 
is a possibility for intraoperative cement extravasation/leakage. 
9.1.5 Postoperative assessment at 3 months (-1,5/+3 months), 12 months (±3 months) and 24 
months (±6 months) 
The following information will be collected at the post-operative visits: 
x
Medication 
x
VAS back and leg pain 
x
ODI 
x
EQ-5D 5L 
x
Adverse Events and/or Device Deficiencies 
x
Protocol deviations 
 
 

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The post-operative assessment at 12 months also includes  
x
An evaluation of neurological status 
x
A radiologic evaluation of: 
o Pedicle screw instrumentation stabilization 
o Fusion status for those subjects where fusion is intended (if no fusion is observed at 1-
year follow-up, it will be at the discretion of the Investigator to follow-up if fusion can be 
observed at 24 months (only if standard of care at the site)). 
o Spinopelvic alignment parameters (only required for deformity subjects) 
 
In case the patient is symptomatic at 24 months and receives a CT-scan or X-ray, stabilization of pedicle 
screw instrumentation and fusion status (for those subjects where fusion is intended) will be assessed. 
 
Every attempt should be made to complete the required onsite clinic visit. However, if a subject is unable 
to complete an onsite visit at 3 months or 24 months, a remote visit source document worksheet can be 
completed by the Investigator/RC to obtain the required data elements. 
The following data can be collected remotely using the remote visit source document worksheet: 
x
Medication 
x
VAS back and leg pain – conducted by phone or via web-based application 
x
EQ-5D-5L – phone version or via web-based application 
x
ODI – phone version or via web-based application 
x
Adverse events and/or device deficiencies 
9.2 Subject Screening  
Every effort will be made to screen subjects consecutively for treatment and enrollment into the FNS 
study. Consecutive enrollment per procedure is essential to minimize selection bias.  
A subject screening log is provided to the site and should be completed by the site’s study staff to maintain 
a cumulative log of all screened subjects per procedure. Subjects not suitable for the study or refusal to 
participate are considered screening failures and should also be collected and reported in the subject 
screening log kept at each site and reported at end of study recruitment. The Investigator will maintain a 
Subject Identification & Enrollment Log of all subjects enrolled in the clinical investigation, assigning a 
subject study ID linked to their names. Subject identifier will not leave the hospital.  

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9.3 Subject Consent 
The Investigator or authorized designee must obtain written informed consent before any clinical study 
related activity takes place. 
Prior to entering the study, the Investigator, or his/her designee, will inform all potential subjects about 
all aspects of the study (e.g. the purpose and nature of the study, procedures, follow-up schedule, and 
expected duration).  
All items addressed in the Patient Information and the Informed Consent Form must be explained. The 
language used shall be as non-technical as possible and must be understandable to the subject. 
The Investigator or designee will discuss the foreseeable risks as well as potential benefits that may result 
from participating in the study and the available alternative therapies.  
The subject must have ample time and opportunity to read and understand the Patient Information and 
the Informed Consent Form, to inquire about details of the clinical study, and to decide whether to 
participate in the clinical study. All questions about the clinical study should be answered to the 
satisfaction of the subject. 
Neither the Investigator, nor the investigation site staff shall coerce or unduly influence a subject to 
participate or to continue to participate in the clinical study. The informed consent process shall not waive 
or appear to waive the subject’s rights. Subjects will be informed by the Investigator or designee that they 
are free to refuse to participate in the study, and if they choose to participate, that they may withdraw 
from the study at any time without compromising further medical care. In addition, subjects will be 
informed that the Investigator may terminate their participation at any time without their consent. 
Written informed consent will be obtained prior to subject enrollment and before any study-specific 
procedures are initiated.   
Whenever new information becomes available that may be relevant to the subject’s confirmed 
participation in the clinical study, Medtronic will revise the written Patient Information and Informed 
Consent Form and inform the Investigators. The revised information will be sent to the Investigator for 
approval or notification by the EC. After approval/notification by the EC, a copy of this information must 
be provided to the participating subjects, and the informed consent process as described above needs to 
be repeated. The Investigator should inform the subject in a timely manner whenever new information 
becomes available that may be relevant to the subject’s confirmed participation in the clinical study.  
Local practice standards will be used to determine appropriateness of mental capacity to be able to 
provide general informed consent. If there is any question, the physician staff attending for the subject 
will have final authority in deciding the subject’s capacity to provide their own informed consent. 
The Investigator or designee will also determine that the potential subject can read, comprehend and 
make a decision regarding study participation.  
The original, signed and dated ICF must be retained in the subject’s study records. The informed consent 
process must be documented in the source documents and a copy of the ICF will be provided to the 
subject. 

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9.4 Assessment of Effectiveness 
Subject-reported outcomes will be assessed pre-operatively and at all follow-up visits. Follow-up 
assessments will be compared to baseline (preoperative) assessments to determine changes in health-
related quality of life, pain, and disability following the surgical procedure. 
9.4.1 Oswestry Disability Index (ODI) 
Disability associated with thoracic/lumbar spine conditions will be assessed using the Oswestry Low Back 
Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This 
validated instrument is considered one of the principal condition-specific outcome measures used in the 
management of spinal disorders. 
The questionnaire will be used at baseline (preoperative) and at 3-month, 12-month and 24-month visits 
(post-operative). 
9.4.2 Back and Leg Pain (VAS) 
Levels of back pain and leg pain will be measured using the Visual Analogue Scales (VAS) at baseline 
(preoperative) and postoperative at 3-month, 12-month and 24-month visits. Subjects will be asked to 
rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the 
worst pain possible. 
A summary of the data will be based on actual measurements or changes in measurements from baseline 
(preoperative) to postoperative scores. 
9.4.3 EQ-5D 5L Questionnaire 
The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire will be used to assess 
health-related quality of life status [24] at baseline and postoperative at 3-month, 12-month and 24-
month visits. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting “no health problems,” 
“slight health problems,” “moderate health problems,” “severe health problems,” and “extreme health 
problems.” The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS will also be utilized 
to document the subject’s self-rated overall health state on a 0 to 100 scale (0 = maximal health-related 
problems, 100 = minimal health-related problems). 
A summary of data from each subject will be based on actual measurements or changes in measurements 
from baseline (preoperatively) to postoperative scores. 
9.4.4 Neurological status 
Neurological status will be evaluated at baseline and at the 12-month follow-up visit.  

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Neurological status is based on four types of measurements (sections): motor, sensory, reflexes, and 
straight leg raising. Each of the sections is comprised of a number of elements. Following scales will be 
used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory 
function (Light Touch or Pin Prick L1 to S1), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 
1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, 
Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full 
Resistance (full strength) and straight leg raise (positive = patient experiences radiating leg pain below the 
knee on elevating the leg between 15 and 70 with the knee extended, normal = no pain is experienced on 
elevating the leg between 15 and 70 with the knee extended). 
Overall neurological success will be defined as maintenance or improvement in all sections (motor, 
sensory, reflex, and straight leg raising) for the time period evaluated. In order for a section to be 
considered a success, each element in the section must remain the same or improve from the time of the 
baseline evaluation to the time period evaluated. Therefore, if any one element in any section does not 
stay the same or improve, then a patient will not be considered a success for neurological status. 
9.4.5 Fusion Status (for those subjects where fusion is intended) 
The surgeon or hospital radiologist will determine fusion status for those subjects where fusion is 
intended. Fusion status will be classified as the following: No fusion success, Fusion success, and Unable 
to determine. The fusion assessment for each subject will be collected at 12 months, preferably by 
collecting a CT-scan, alternatively fusion may also be collected through X-rays. The criterion for fusion 
when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony 
bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted 
devices). A partial fusion (a fusion not meeting these criteria) should be recorded as “No fusion success”. 
For multi-level subjects, fusion success will be assessed for each level and overall fusion status for a subject 
will be defined as achieving fusion at all treated levels. If one level’s fusion status could not be determined 
while all the levels are success, then the subject level is considered unable to determine. 
If no fusion is observed at the 12-month follow-up, it will be at the discretion of the Investigator to follow-
up if fusion can be observed at 24 months (only if standard of care at the site). 
In case the patient is symptomatic at 24 months and receives a CT-scan or X-ray, fusion status will be 
assessed. 
9.4.6 Stabilization of the pedicle screw instrumentation  
The surgeon or hospital radiologist will review radiographs and or CT’s to assess for evidence of 
instability of the pedicle screw instrumentation at 12 months.   
The following are signs of instrumentation instability: 
x
Screw pullout 
x
Screw loosening 

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x
Screw toggle 
 
In case the patient is symptomatic at 24 months and receives a CT-scan or X-ray, stabilization of pedicle 
screw instrumentation will be assessed. 
9.4.7 Spinopelvic alignment 
Collection of spinopelvic parameters can show us if the patient’s spine is balanced or not prior to and after 
the surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment 
or a mechanism of regulation/compensation due to an evolution of the spinal alignment.  
 
The following spinopelvic alignment parameters will be assessed in the deformity patients on standing, 
frontal and sagittal full spine X-ray (at least C7 + femoral head must be visible): 
-
Coronal alignment:  
o Distance between C7 plumb line (vertical line from the center of the C7 vertebral body) 
and the central sacral vertical line (CSVL) (vertical line drawn from the center of the 
sacrum). 
o Coronal curve type: the curve type is determined on the basis of maximal coronal angle 
measured according to standard Cobb technique and will be classified as: 

Curve type T: patients with a thoracic major curve of >30˚ (apical level of T9 or 
higher) 

Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical 
level of T10 or lower) 

Curve type D: patients with a double major curve, with each curve >30˚. 

Curve type N: patients with no coronal curve >30˚. 
The standard cobb technique to measure coronal angles should be done by drawing a line perpendicular 
to a second line drawn across the superior endplate of the upper-end (most tilted) vertebra and the 
inferior endplate of the lowed end vertebra. The angle formed by the intersection of the two 
perpendicular lines is the Cobb angle, which is the measure of the magnitude of the curve (see Figure 2).  

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Figure 2: Cobb angle measurement technique. 
 
-
Sagittal alignment: 
o Regional parameters:  

Thoracic Kyphosis (TK): Cobb angle between the superior endplate of T4 and 
inferior endplate of T12.  

Thoracolumbar kyphosis (TLK): Cobb angle between the superior endplate of T10 
and inferior endplate of L2. 

Lumbar lordosis (LL): Cobb angle between the superior endplate of L1 and 
superior endplate of S1.  
o Global parameter: sagittal vertical axis (SVA): distance between a vertical plumb line from 
the center of the C7 vertebra to the posterior superior corner of the sacrum. 
-
Sagittal spinopelvic parameters:  
o Pelvic Incidence (PI): angle formed by the intersection of two lines including (1) a 
perpendicular line that is extended caudal from the middle of the S1 superior endplate 
and (2) a line that extends from the middle of the S1 superior endplate to the center of 
the bicoxofemoral axis. 
o Pelvic Tilt (PT): angle formed by the intersection of two lines including (1) a line that 
extends from the middle of the S1 superior endplate to the center of the bicoxofemoral 
axis and (2) a vertical line that is extended from the bicoxofemoral axis. 
o Sacral Slope (SS): angle formed by the intersection of two lines including (1) a line that 
parallels the superior endplate of the sacrum and (2) a horizontal line that is extended 
from the posterior, superior corner of the sacrum.  
 
The deformity patients will be classified using the Scoliosis Research Society-Schwab Adult Spinal 
Deformity Classification (see Figure 3) [25].  

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Figure 3: Guide to the SRS-Schwab Adult Spinal Deformity Classification system, including curve type and 3 
sagittal modifiers.  
 
Spinopelvic parameters will be assessed in the deformity patients only. The assessment will be done at 
baseline, prior to hospital discharge (for those sites where this is done as part of the standard of care) and 
at 12 months. In case the deformity patient is symptomatic at 24 months and receives a standing, frontal 
and sagittal full spine X-ray (at least C7 + femoral head must be visible), spinopelvic parameters will be 
assessed. 
9.5 Assessment of Safety 
Subjects will be assessed for potential adverse events and device deficiencies (as defined in Section 11.2). 
9.5.1 Intraoperative cement extravasation/leakage 
Subjects will be assessed for intraoperative cement extravasation/leakage. Both symptomatic and 
asymptomatic cement extravasation/leakage should be reported. In case the cement extravasation is 
symptomatic to the patient this should be documented in the AE eCRF. In case the cement extravasation 
is asymptomatic to the patient this should be reported in the DD eCRF.  It is at the Investigator’s discretion 
to do a post-operative CT to assess pulmonary embolism in case there is an indication for intraoperative 
cement extravasation/leakage. 

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9.5.2 Device and/or procedure related adverse events  
Device and/or procedure related adverse events will be collected through 24 months follow-up. These 
should be documented in the AE eCRF. 
9.5.3 Secondary surgery at the index and/or adjacent level(s) throughout the study 
When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of 
insufficient outcomes of the initial surgery. Additional surgeries at the index and/or adjacent level(s) will 
be collected in the AE eCRF, including cases when the Investigator or study personnel becomes aware of 
a second surgery at the index and/or adjacent level in another hospital. 
Pre-planned secondary surgeries at the index and/or adjacent level(s) should not be reported as adverse 
events on the AE eCRF but instead a second surgery eCRF should be completed. The pre-planned 
secondary surgery should be performed within 3 months as of the time of the initial surgery. There should 
be at least 1 month in between the pre-planned secondary surgery and 3-month (-1,5/+3 months) follow-
up visit to reduce any bias on the patient reported outcomes.    
9.6 Imaging guidelines 
Study subjects are required to undergo imaging procedures at specified time points during the study and 
these will be obtained per the site’s practice. To ensure consistency in the type and quality of all images 
obtained throughout this study some requirements have been defined: 
x
Clinical sites must use imaging equipment (DXA, X-ray, (q)CT-scan) that are maintained and 
calibrated according to the manufacturer’s specifications when performing imaging procedures 
on subjects for this study. Imaging equipment maintenance and calibration will be monitored.  
x
To reduce the radiation exposure to study subjects, all DXA, X-ray and (q)CT examinations should 
be realized at the lowest radiation dose that still provides the minimally required image quality. 
9.7 Recording Data 
The Investigator must ensure accuracy, completeness and timeliness of the data reported in the eCRFs 
and in all other required reports. Data reported on the eCRFs must be consistent with the source 
documents, and discrepancies need to be justified in a documented rationale, signed and dated by the 
Investigator, and filed in the subject medical file or appropriate location.
Patient neurological status can be recorded directly on the eCRF and is considered source data.  
All other source data entered in the eCRFs should be located in the subject’s medical records/source 
document (electronic or paper), (e.g., hospital records, surgery reports, x-rays, MRIs, CTs, or any other 
material that contains original information used for data collection including the documentation of AEs 

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and study source document completed by the Investigator or site staff). Subject completed questionnaires 
as well as data collected during subject phone calls will be considered as source data. 
This study will be conducted using a remote data capture system. The Oracle Clinical Remote Data Capture 
(RDC) system allows the study centers to enter study data into the sponsor’s database over a secure 
internet connection. Required data will be taken from source documents and directly entered into the 
study database by authorized site personnel in accordance with applicable regulations. 
Every attempt should be made to complete the required onsite clinic visit. However, if the subject is 
unable to return to the investigational site for their scheduled clinic visit at 3 months and 24 months, the 
study site can contact the subject and collect the following data remotely using the remote visit source 
document worksheet: 
x
Medication 
x
VAS back and leg pain – conducted by phone or web-based application 
x
EQ-5D-5L – phone version or web-based application 
x
ODI – phone version or web-based application 
x
Adverse events and/or device deficiencies 
The Principal Investigator or an individual delegated by the Principal Investigator on the Delegation of 
Authority Log, is responsible for documenting and entering data for the study on the eCRFs.  
Only authorized persons can complete CRFs. CRFs shall be signed by Principal or Sub-Investigators 
(physicians only) as specified on the Delegation of Authority Log included in the Investigator Site File. The 
Principal Investigator or delegated Sub-Investigator is required to approve all data on CRFs via electronic 
signature. 
9.8 Deviation Handling 
A study deviation is an event where the Investigator or site personnel did not conduct the clinical study 
according to the Clinical Investigational Plan or Clinical Investigation Agreement. The Investigator is not 
allowed to deviate from the above-mentioned documents except under emergency circumstances to 
protect the rights, safety and well-being of human subjects. All deviations shall be documented in the 
eCRF and explained, regardless the reason for the deviation. 
In this post market release study with a prospective design, Protocol Deviations are defined as deviations 
related to: 
x
Patient Informed Consent procedure 
x
Enrolled subject does not meet Inclusion/Exclusion criteria 
x
Visit not done 

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x
Assessment(s) at the visit not performed 
x
Visit outside the CIP defined visit window 
x
Subject did not undergo fenestrated screw procedure as defined in this protocol 
x
Improper AE / SAE / ADE / SADE / DD reporting 
x
EC approval not obtained, if required 
Medtronic will assess the significance of all deviations and evaluate the need to amend the Clinical 
Investigation Plan, to early terminate the investigation or site termination in case the deviations only 
relate to one site, in accordance with Medtronic SOPs. 
9.8.1 Request for approval of study deviations 
This is a study conducted within the IFU of the used Devices and due to the nature of the Protocol 
Deviations as defined in the section above pre-approval for study deviations will not be applied in this 
post market release study. 
In any situation during the conduct of this study the Investigator shall exercise his/her judgment to always 
safeguard the subject’s interest independent whether the action to be taken will lead to a Protocol 
Deviation or not. The Investigator shall report the deviation as soon as possible to Medtronic and the 
reviewing EC, as required. Medtronic will inform the regulatory authorities, if required. 
9.8.2 Reporting requirements for study deviations 
The Investigator shall adhere to EC requirements and procedures for reporting study deviations and shall 
report the deviation as soon as possible to Medtronic. Medtronic is responsible for analyzing deviations, 
assessing their significance, and identifying any additional corrective and/or preventive actions (e.g. 
amend the CIP, additional training, terminate the study, etc.). Repetitive or serious Investigator 
compliance issues may result in the need to initiate a corrective action plan, and in some cases, freeze 
enrollment or ultimately terminate the Investigator’s participation in the clinical study. Medtronic will 
provide investigation site-specific reports to the Investigators on a yearly basis summarizing information 
on deviations that occurred at the investigational site. 
9.8.3 Amendments to the Clinical Investigation Plan 
The Investigator will propose any appropriate modification(s) of the Clinical Investigation Plan or 
investigational device or investigational device use. Medtronic will review this proposal and decide 
whether the modification(s) will be implemented. 
Medtronic will submit any significant amendment to the Clinical Investigation Plan, including a 
justification for this amendment, to the appropriate regulatory authorities and to the Investigators to 
obtain approval from their EC and Regulatory Authorities, if applicable. Administrative amendments to 

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the Clinical Investigation Plan will be submitted to the EC and appropriate regulatory authorities for 
notification, if applicable. 
Furthermore, Investigators shall sign any approved amendment for agreement. 
9.9 Subject Withdrawal or Discontinuation  
Subjects are free to voluntarily withdraw from the study at any time and for any reason. The Investigator 
can only withdraw a subject from the study with a valid reason. Withdrawn or exited subjects will be 
followed under normal medical practice. Examples of reasons for subject discontinuation include, but are 
not limited to, those listed below: 
x
Patient Informed Consent procedure not followed 
x
Subject does not meet all eligibility criteria 
x
Subject death 
x
Subject lost to follow-up 
x
Subject voluntarily withdraws from the study 
x
Subject did not undergo the fenestrated screw procedure as defined in this protocol 
 
If a subject is withdrawn from the study, the reason for withdrawal (if known) shall be recorded in the 
eCRF and in the subject’s hospital record.  
 
Subjects withdrawn from the study will only be replaced when subjects did not meet baseline eligibility 
or did not undergo the fenestrated screw procedure as defined in this protocol and if the enrollment is 
still open.  
Compliance to the minimum recommended follow-up schedule is essential to enable the analysis of the 
results in a scientifically sound and meaningful way. If, for whatever reason, the subject follow-up cannot 
be scheduled within the time window or occurred outside the time window, it is still essential to schedule 
a follow-up visit and to document the subject data at a date as close as possible to the calculated follow-
up date. 
As much as possible, it should be avoided that subjects are lost-to-follow-up and Investigators are urged 
to do their utmost best to maintain patient’s follow-up compliance as per CIP. 
 
9.9.1 Withdrawal of consent: 
Subjects may withdraw from the study at any time and for any reason. If a subject withdraws from the 
study, the reason for withdrawal will be documented, if given by the subject, in the source documents 

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and in the subject’s eCRF. If a subject withdraws consent, they will not be replaced. The follow up of these 
subjects will be according to the standard of care at the site. 
 
9.9.2 Lost to follow up: 
Before considering a subject as lost to follow up, the Investigator should make every attempt to contact 
the subject (or relevant other persons associated with the subject) to have the subject return for follow-
up to determine their clinical status and the occurrence/resolution of AEs, if any. 
Before documenting a subject as lost to follow up, the Investigator should document in the eCRF and 
source documents at least 3 contact attempts with the subject, subject’s relatives or other persons 
associated with the subject. In addition, the Investigator should make a reasonable effort to ascertain the 
reason(s), while fully respecting the subject's rights (e.g. if a subject is deceased, the date of death should 
be completed or if the subject is alive, the date of last contact with subject should be provided). 
10. Risks and Benefits 
10.1 Potential Risks 
In all clinical studies, confidentiality of protected health information (PHI) may be breached due to study-
related activities beyond those of routine clinical care. This risk will be minimized by not collecting 
personally identifying information on case report forms. 
The Investigator must continuously monitor, assess and document the risks (Declaration of Helsinki 2013). 
Medtronic is not aware of any significant problems with this product. In the clinical study, the products 
will be used in accordance with their labeling; therefore, no risks other than the risks typically associated 
with a routine device implantation and follow-ups are anticipated. Reference is made to the IFU for a 
detailed list of all risks and contra-indications associated with the devices. Please specifically note that the 
CD HORIZON® Legacy™ Fenestrated Screws are contraindicated for pedicular/posterior wall defects and 
the CD HORIZON® Solera™ Fenestrated Screws are contraindicated for pedicular/posterior wall defects 
when used with cement. 
In addition, subjects are treated according to general clinical practice. No additional risks are associated 
with participation in this clinical study.  
10.1.1 Risk of imaging/Radiation 
At baseline, a hip DXA scan or spine qCT-scan will be collected depending on the hospital practice. For 
some patients/sites the hip DXA scan will be part of their standard of care, while for others this may not 
be the case. The worldwide average effective dose from natural background radiation is 2.4 mSv/year. An 
adult hip DXA has been reported to have an effective dose of 0.009 mSV [26]. At baseline and during 
follow-up, X-ray and/or CT-scan will be collected according to the standard of care so no additional 
radiation risk is expected. For those countries where the X-ray and/or CT-scan is not standard of care at 

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the 12-month visit, the patient will be informed about the additional radiation risk and the EC and 
regulatory body (if applicable) will be notified. 
To conclude, the additional radiation risk associated with participation in this clinical study is negligible. 
10.2 Potential Benefits 
There may be no direct benefits of study participation. However, subject participants may undergo an 
enhanced level of clinical scrutiny of back health compared to routine clinical care, which may provide 
some indirect health benefits. 
10.3 Risk-Benefit Rationale 
Participation in this study will not expose the subject to greater risks than if he/she were receiving the CD 
HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement outside of the study. There 
might be other discomforts and risks related to the CD HORIZON® Fenestrated Screw Spinal System with 
Fenestrated Screw Cement and/or this study that are not foreseen. The risks are minimized by selecting 
only qualified Investigators experienced in the field of application and trained in the use of the study 
device(s) and qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation.   
11. Adverse Events and Device Deficiencies 
All AEs, DDs and deaths, regardless of relatedness to surgical procedure or outcome, should be reported 
throughout the study in the eCRF and should be made available to the Medtronic study team. If applicable, 
these AEs and DDs will be reported to other countries where studies are conducted with the same or a 
similar product. All AEs and DDs will be screened immediately for possible product complaints, to allow 
compliance with the 48 hours reporting requirement.  
11.1 Definitions/Classifications 
Medtronic and the Investigator will classify each adverse event according to ISO 14155:2011. Adverse 
events and device deficiencies are defined as follows 
 
 
 
 
 
 
 

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Table 11-1: Definitions 
ISO Definitions for Clinical Investigations of Medical Devices for Human Subjects 
Adverse Event (AE): (ISO14155:2011 3.2) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device 
NOTE 1: This definition includes events related to the investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to investigational medical devices. 
Adverse Device Effect (ADE): (ISO14155:2011 3.1) 
Adverse event related to the use of an investigational medical device 
NOTE 1: This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the investigational medical 
device 
Device Deficiency (DD): (ISO 14155:2011 3.15; ISO 14155:2011 3.27; ISO 14155:2011 3.43) 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or 
performance. 
Note: Device deficiencies include malfunctions, use errors, and inadequate labeling. 
x
Malfunctions: Failure of an investigational medical device to perform in accordance with its 
intended purpose when used in accordance with the instructions for use or Clinical 
Investigational Plan (CIP) 
x
Use Error: Act or omission of an act that results in a different medical device response than 
intended by the manufacturer or expected by the user 
Note: Use error includes slips, lapses, and mistakes. 
Note: An unexpected physiological response of the subject does not in itself constitute a use error. 
SERIOUSNESS 
Serious Adverse Event (SAE): (ISO 14155:2011 3.37) 
An adverse event that 
a) led to death, 
b) led to serious deterioration in the health of the subject, that either resulted in 
x
a life-threatening illness or injury, or 

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x
a permanent impairment of a body structure or a body function, or 
x
in-patient or prolonged hospitalization, or 
x
medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect. 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, without serious deterioration 
in health, is not considered a serious adverse event. 
Serious Adverse Device Effect (SADE): (ISO 14155:2011 3.36) 
Adverse device effect that has resulted in any of the consequences characteristic of a Serious Adverse 
Event. 
Unanticipated Serious Adverse Device Effect (USADE): (ISO 14155:2011 3.42) 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report 
NOTE: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or outcome has 
been identified in the risk analysis report. 
RELATEDNESS 
Relationship of 
Adverse Events 
The Investigator’s assessment of causality must be provided for all adverse 
events.  Adverse events that are related or possibly related to the device, 
index surgical procedure, or both will be assessed for this study on the 
following basis:   
1. Not related: relationship to the device or procedures can be excluded 
when: 
x
The event is not a known side effect of the product category the device 
belongs to or of similar devices and procedures; 
x
the event has no temporal relationship with the use of the 
investigational device or the procedures; 
x
the serious event does not follow a known response pattern to the 
medical device (if the response pattern is previously known) and is 
biologically implausible; 
x
the discontinuation of medical device application or the reduction of 
the level of activation/exposure when clinically feasible and 
reintroduction 
of 
its 
use 
(or 
increase 
of 
the 
level 
of 
activation/exposure), do not impact on the serious event; 

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x
the event involves a body-site or an organ not expected to be affected 
by the device or procedure; 
x
the serious event can be attributed to another cause (e.g. an 
underlying or concurrent illness/ clinical condition, an effect of 
another device, drug, treatment or other risk factors); 
x
the event does not depend on a false result given by the 
investigational device used for diagnosis, when applicable;  
x
harms to the subject are not clearly due to use error. 
 
To establish the non-relatedness, not all the criteria listed above might be 
met at the same time, depending on the type of device/procedures and the 
serious event.  
2. Unlikely: The relationship with the use of the device seems not relevant 
and/or the event can be reasonably explained by another cause, but 
additional information may be obtained. 
3. Possible: The relationship with the device is weak but cannot be ruled out 
completely; alternative causes are also possible (e.g. an underlying or 
concurrent illness/ clinical condition or/and an effect of another device, drug 
or treatment). Cases where relatedness cannot be assessed or no 
information has been obtained should also be classified as possible. 
4. Probable: The relationship with the use of the device seems relevant 
and/or the event cannot reasonably be explained by another cause, but 
additional information may be obtained. 
5. Causal relationship: the serious event is associated with the 
investigational device or with procedures beyond reasonable doubt when: 
x
the event is a known side effect of the product category the device 
x
belongs to or of similar devices and procedures; 
x
the event has a temporal relationship with the investigational device 
x
use/application or procedures; 
x
the event involves a body-site or organ that 
o
the investigational device or procedures are applied to; the 
investigational device or procedures have an effect on; the 
serious event follows a known response pattern to the 
medical device (if the response pattern is previously known); 
x
the discontinuation of medical device application (or reduction of the 
level of activation/exposure) and reintroduction of its use (or increase 
of the level of activation/exposure), impact on the serious event 
(when clinically feasible); 

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x
other possible causes (e.g. an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug or treatment) have 
been adequately ruled out; 
x
harm to the subject is due to error in use; 
x
the event depends on a false result given by the investigational device 
used for diagnosis, when applicable; 
x
In order to establish the relatedness, not all the criteria listed above 
might be met at the same time, depending on the type of device 
/procedures and the serious event. 
 
 
SECONDARY SPINAL SURGICAL PROCEDURES 
Secondary spinal 
surgical procedures 
 
Secondary spinal surgical procedures will be classified using the following 
definitions, based on the description provided: 
•           Revision:  A procedure that adjusts or in any way modifies the original 
implant configuration at the index level(s).  This includes implantation of any 
product to enhance fusion, such as autogenous or allogenic bone graft, bone 
graft substitutes, or bone growth stimulators.  This also includes replacement 
of any device component; supplemental placement of a spinal fixation 
system; or an uninstrumented posterior, posterolateral, or anterior fusion 
surgical intervention. 
•           Removal:  A procedure that removes one or more components of the 
original implant configuration.  Possible reasons for removals can be elective 
(subject preference) or non-elective (surgeon clinical decision).  Non-elective 
removal is the result of an adverse event or treatment failure.  This may 
occur in the case of migrated, bent, broken or infected device 
components.  Whether removal is elective or non-elective, fusion or non-
fusion should be noted at the index level(s). 
•           Reoperation:  Any surgical procedure at the index level that is not 
classified as a revision or removal. 
•           Other:  Any additional surgical procedure not classified as a revision, 
removal or reoperation. 
 
Note: Although the use of external bone growth stimulators will not be 
considered a subsequent/secondary surgical procedure, use of external bone 
growth stimulators to treat the index level(s) will be documented and 
summarized. 

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11.2 Reporting of Adverse Events 
All adverse events will be considered reportable for this study.  
Pain, neurological and function symptoms should be reported as an adverse event when a subject’s 
complaint for any of these symptoms results in an unscheduled visit or when a subject presents with new 
or worsening pain, neurological and/or function symptoms as compared to the previous visit. 
All adverse events will be classified using the following responsibility matrix: 
Table 11-2: Event Classification Responsibilities 
What is Classified 
Who Classifies 
Classification Parameters 
Relatedness 
Investigator and Medtronic 
Procedure related 
Device related 
USADE potential 
Medtronic 
USADE 
Seriousness 
Investigator and Medtronic 
SAE/SADE 
Diagnosis 
Investigator 
Based on presenting signs and 
symptoms and other supporting data 
All reportable events must be recorded from procedure start onwards in the subject’s medical record and 
on the Adverse Event and/or Device Deficiency eCRF and promptly reported to Medtronic. Procedure start 
for this study is defined as the time when a patient is prepared for the surgery prior to entry to the 
operating room theater. EC reporting must be completed in accordance with the policies of the governing 
EC. Regulatory Authority reporting should be in accordance with applicable local regulations. 
It is the responsibility of the Investigator to identify the occurrence of adverse events and device 
deficiencies and to ensure the required information is accurately documented on the eCRF. 
Reports of adverse events and device deficiencies will include the following information, at a minimum: 
x
Date of event 
x
Diagnosis or description of the event 
x
Assessment of the seriousness and relationship to the device and/or index surgical procedure 
x
Treatment provided 
x
Outcome and date of resolution 
The clinical course of each adverse event must be followed until resolution, subject discontinuation from 
the study or last study follow up visit, whichever comes first. “Not resolved” adverse events and device 
deficiencies must be assessed at each protocol required visit, and new or updated information must be 
documented on the Adverse Event and/or Device Deficiency eCRF and promptly reported to Medtronic 
and if applicable to the EC.  At time of study exit the status of all unresolved Adverse Events should be 
evaluated and should reflect subject' status at time of study exit. 

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If necessary, the Investigator may report to the sponsor initially by telephone or email and follow-up with 
completed eCRFs and, upon request of Medtronic, de-identified source documentation regarding the 
event (e.g., physician/nurse notes or summaries) should be provided to Medtronic. When printouts of 
original electronic source documents are obtained, these shall be signed and dated by a member of the 
Investigator site team with a statement that this is a true reproduction of the original source document. 
Medtronic study personnel will promptly review all reported adverse events and device deficiencies and 
if necessary request clarification and/or additional information from the Investigator. If Medtronic 
disagrees with the Investigator’s assessment of the adverse event relationship to the device and/or 
procedure, Medtronic study personnel will document the disagreement and report or ensure reporting of 
both opinions to the EC and regulatory authority as necessary. In addition, aggregate safety data will be 
reviewed and analyzed to identify potential safety issues, signals, and trends at minimum, annually after 
start of subject enrollment. 
11.3 Not reportable events 
Examples of events that are not reportable as adverse events for this study are: 
x
Inability to successfully perform the procedure, unless injury or device deficiency occurs. 
x
A documented pre-existing condition unless there is a worsening of the nature, severity, duration, 
or frequency of that condition. 
x
Pre-planned medical or surgical procedures (e.g., surgery, endoscopy, tooth extraction, 
transfusion, cosmetic elective surgery); however, the condition leading to the procedures might 
be a reportable event if there is a worsening of the nature, severity, duration, or frequency of that 
condition. 
Table 11-3 provides a list of expected surgical events. An expected surgical event will not be considered 
reportable unless it worsens or is present outside the stated timeframe post-procedure. 
 
Table 11-3: Expected Surgical Adverse Events and Duration 
Event Description 
Timeframe from the Surgical Procedure 
Anesthesia related nausea / vomiting 
24 hours 
Low-grade fever (<100°F or 37.8°C) 
48 hours 
Mild to moderate bruising / ecchymosis 
7 days 
Seroma 
72 hours 
Sleep problems (insomnia) 
72 hours 
If necessary, the Investigator may report to the sponsor initially by telephone or email and follow-up with
completed eCRFs and, upon 

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11.4 Device Deficiencies 
A device deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and 
inadequate labeling. All device deficiencies must be documented and submitted to Medtronic on the 
Device Deficiency eCRF. In addition, the Investigator must also determine and document on the eCRF 
device deficiencies that did not lead to adverse event but could have led to a serious adverse device effect: 
x
if either suitable action had not been taken, 
x
if intervention had not been made, or 
x
if circumstances had been less fortunate 
x
Refer to Table 14-1 for Investigator reporting timelines for device deficiencies. 
11.5 Reporting Adverse Events, Serious Adverse Events, Serious Adverse Device 
Effects, and Device Deficiencies to Medtronic 
Reporting timelines can be found in Table 14-1. The preferred way of transmission of AEs and DDs is the 
Oracle Clinical (eCRF) system, but in case the eCRF cannot be accessed, the Investigator can send an email 
to rs.mstsafetyspine@medtronic.com.  
The AE/DD worksheet that can be found in the patient binders may be used for completion of available 
information, preferably signed by Investigators and attached to the email. 
The same CIP reporting timelines apply for all types of reporting as if the eCRF would be available. 
11.6 Deaths 
All subject deaths must be reported to Medtronic and the EC as soon as possible, after learning of a 
subject’s death, regardless of whether or not the death is related to the device system and/or procedure. 
The Investigator should also attempt to determine, as conclusively as possible, whether such deaths are 
related to the device system and/or procedure. If the death is evaluated as device and/or procedure 
related and unanticipated, the event will be reported as a USADE by Medtronic or its designee to the 
appropriate regulatory agencies. 
Any subject death will be reported on the Adverse Event and Study Exit eCRFs. If limited information is 
known, the Adverse Event eCRF must be completed with available information as soon as possible. 
12. Data Review Committees  
This study will not use a Clinical Events Committee or Data Monitoring Committee. All devices will be used 
according to the IFU and patients will be treated according to general clinical practice. Aggregate safety 

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data will be reviewed and analyzed to identify potential safety issues, signals and trends at minimum, 
annually after start of subject enrollment. 
If a death occurs attributable to the FNS cement, the study will be terminated. 
13. Statistical Design and Methods 
This is a prospective, single arm and multicenter evaluation of the CD HORIZON® Fenestrated Screw Spinal 
System with Fenestrated Screw Cement used in the treatment of spinal conditions in subjects with 
compromised bone quality. 
The Statistical Analysis Plan (SAP) will be developed prior to data analysis and will include a comprehensive 
description of the statistical methods used for the final study report. Any change from the original SAP 
will be reported in the final study report, along with justification for the change(s). 
13.1 Statistical Methods 
The primary endpoint of the study is the improvement of ODI at 12-month visit from baseline and the 
primary objective of the study is to demonstrate that the improvement of ODI at 12-month visit from 
baseline is significantly greater than 0 for each indication subgroup.   
The null hypothesis is H0: u_ODI  ≤ 0, and the alternative hypothesis is Ha: u_ODI > 0  where u_ODI is the mean 
improvement of ODI score at 12 months from baseline. 
A paired t-test for normally distributed data or Wilcoxon signed rank test for not normally distributed data 
will be carried out to test whether the mean improvement from baseline is significantly greater than 0. If 
p-value is ≤ 0.05, then primary objective is met. In addition, the descriptive statistics including mean, 
standard deviations, minimum and maximum will be presented. 
For the secondary endpoints including improvement of ODI from baseline at 3- and 24-month visit, 
improvement of VAS back and leg pain score from baseline at 3-, 12- and 24-month visit and improvement 
of EQ-5D 5L from baseline at 3-, 12- and 24-month visit, similar methods as the one used for the primary 
endpoint will be used. 
For the secondary endpoints including neurological success at 12-month visit, intraoperative cement 
extravasation/leakage, pedicle screw instrumentation stabilization at 12-month visit and fusion success 
at 12-month visit, simple frequencies will be summarized.  As for secondary endpoints including Device 
and/or procedure related adverse events through 24-months and secondary spinal surgeries at index 
and/or adjacent level(s), resulting from an AE, up to 24 months after the surgery, the event rate will be 
estimated using time-to-event analysis. 
The above analyses will be done separately for each indication subgroup. For the deformity group, the 
secondary endpoints, change in coronal and sagittal spinopelvic parameters from baseline at 12-month 
visit, will be analyzed using the same method as the one for the primary endpoint.

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13.2 Sample Size 
For the primary endpoint, conservatively assuming the true mean improvement from baseline at 12-
month visit to be 10 and the standard deviation is 24, the required sample size is 38 using alpha level = 
0.05 and 80% power. Again, conservatively assuming 20% attrition rate, the requirement sample size is 
48. The study plans to enroll around 50 subjects (no less than 48 subjects) in each indication subgroup. 
13.3 Analysis Dataset 
All the analysis will be based on the primary dataset which consists of all subjects who are enrolled in this 
study, undergo the intended surgical procedure and receive the study device. The per-protocol dataset, 
which excludes from the primary dataset all subjects who violate inclusion/exclusion criteria may also be 
derived in the case there are a meaningful number of major protocol deviations. 
Subjects from all sites will be pooled together. The analysis will be based on the observed data. Missing 
data will not be imputed. 
13.4 Interim Analysis 
An interim analysis will be performed when all the subjects in the degenerative spinal disease indication 
subgroup have reached the 12-month visit. We anticipate that all 12-month clinical outcomes including 
the primary endpoint will be finalized at the time of interim analysis. Hence the conclusion on the primary 
objective should remain unchanged when conducting the final analysis. 
14. Ethics 
14.1 Statement(s) of Compliance  
The study will be conducted in accordance with this protocol, ISO14155:2011 and the ethical principles 
that have their origin in the Declaration of Helsinki 2013, all applicable laws and regulatory requirements 
of the countries in which the study is conducted, including data protection laws and the clinical trial 
agreement. 
The principles of the Declaration of Helsinki have been implemented in this study by means of the patient 
informed consent process, EC approval, risk benefit assessment, study training, clinical trial registration, 
and publication policy. Study Investigators will be required to sign an Investigator Statement stating their 
intent to adhere to applicable regulations. 
The clinical investigation shall not begin at any site until the required approval/favorable opinion from the 
Ethics Committee (EC) or notification/approval from a regulatory authority have been obtained, if 
appropriate. 
Any additional requirements imposed by the EC or regulatory authority shall be followed, if appropriate. 

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14.2 Principal Investigator Obligation 
Each site will have a Principal Investigator (PI). The PI has overall responsibility for the day-to-day conduct 
of the trial at the site and for the integrity of the trial data generated by their site.  
Specifically, the PI is responsible for the following:  
x
Protecting the rights, safety, and welfare of the subjects in their care 
x
Obtaining written informed consent of all subjects prior to any trial-related procedures, and only 
after Ethics Committee and regulatory approval (if applicable) of the trial 
x
Obtaining and maintaining Ethics Committee approval 
x
Conducting the investigation in accordance with the signed agreement, clinical investigation plan, 
applicable laws and regulations, and any conditions of approval imposed by an Ethics Committee 
or regulatory authority 
x
Providing accurate financial disclosure to the sponsor, including any relevant changes during the 
course of the trial and for 1 year after the completion of the trial. 
x
Reporting adverse events and device deficiencies in accordance with the CIP and according to 
country regulations 
x
Approving all case report forms (or authorizing a Sub-Investigator to do so); approval of the case 
report form indicates the data represented are accurate and have been reviewed. 
x
Maintaining accurate, complete, and current records, including: 
o All correspondence with another Investigator, the sponsor, the monitor, the Ethics 
Committee (including required reports), or regulatory agency 
o Records of each consented subject’s case history signed and dated informed 
consent(s), exposure to the device, eCRFs, and source documents 
o The CIP, and documentation of dates of and reasons for each protocol deviation 
o Any records required by a regulatory agency 
x
Ensuring that clinical records are clearly marked to indicate that the subject is enrolled in the 
study. 
x
Allowing time with the trial monitor and Sponsor trial staff members during Sponsor site visits 
x
Informing the sponsor if any action is taken by an Ethics Committee or regulatory authority 

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Failure to perform the Investigator obligations or to complete corrective and preventive actions identified 
during monitoring or auditing activities may result in Principal Investigator or site personnel 
disqualification, and/or lead to suspension or termination of the study at the site. 
14.3 Reporting requirements 
Table 14-1 includes minimum reporting requirements for Investigators participating in studies in Europe. 
Medtronic study personnel will immediately report Adverse Events and Device Deficiencies, related to CE 
marked devices used during the study, to Medtronic’s Complaint Handling Unit who will ensure prompt 
review, and appropriate reporting. 
Table 14-1: Reporting requirements 
Serious Adverse Events (SAEs) 
Investigator submit to: 
Medtronic 
Immediately after the Investigator first learns of the event or of new information in 
relation with an already reported event (within 3 calendar days). 
EC 
Reporting timeframe as per local EC per local requirement. 
Sponsor submit to: 
EC 
Reporting timeframe as per local EC per local requirement. 
Regulatory Authorities 
Reporting timeframe as per local requirement. 
Serious Adverse Device Effects (SADEs) 
Investigator submit to: 
Medtronic 
Immediately after the Investigator first learns of the event or of new information in 
relation with an already reported event (within 3 calendar days). 
EC 
Reporting timeframe as per local EC per local requirement. 
 
Sponsor submit to: 
EC 
Reporting timeframe as per local EC per local requirement. 
Regulatory Authorities 
Reporting timeframe as per local requirement. 
 
 

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Unanticipated Serious Adverse Device Effects (USADEs)  
 
Investigator submit to: 
Medtronic 
Immediately after the Investigator first learns of the event or of new information in 
relation with an already reported event (within 3 calendar days). 
EC 
Reporting timeframe as per local EC per local requirement. 
Sponsor submit to: 
Investigators 
Notification as soon as possible and not later than 10 working days after the sponsor first 
learns of the effect. 
EC 
Reporting timeframe as per local EC per local requirement. 
Regulatory Authorities 
Reporting timeframe as per local requirement. 
All Other Adverse Events 
Investigator submit to: 
Medtronic 
Submit within 20 calendar days after the Investigator first learns of the event. 
EC 
Reporting timeframe as per local EC per local requirement. 
Device Deficiencies (DD) with SADE potentials 
Investigator submit to: 
Medtronic 
Immediately after the Investigator first learns of the deficiency or of new information in 
relation with an already reported deficiency (within 3 calendar days). 
EC 
Reporting timeframe as per local EC requirement. 
Sponsor submit to: 
EC 
Reporting timeframe as per local EC requirement. 
Regulatory Authorities 
Reporting timeframe as per local requirement. 
All other Device Deficiencies 
Investigator submit to: 
Medtronic 
Submit within 20 calendar days after the Investigator first learns of the deficiency. 

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EC 
Reporting timeframe as per local requirement. 
Withdrawal of EC Approval 
Investigator submit to: 
Medtronic 
Report a withdrawal of the reviewing EC approval within 5 days of Investigator 
notification. 
Interim Reports and Final Report 
Investigator submit to: 
EC 
Study reports must be submitted as required by EC per local requirement. 
Sponsor submit to:  
Regulatory Authorities 
Study reports must be submitted as required by applicable local regulation. 
14.4 Oversight of Study Personnel 
The Principal Investigator may delegate study-related tasks to appropriate trained and qualified personnel 
to ensure alignment between contractual obligations and delegated study responsibilities. 
The delegation of study-related tasks will be documented on the Delegation of Authority Log and the 
Principal Investigator will provide ongoing oversight of all delegated study-related tasks. 
The Principal Investigator will ensure training is provided, completed and documented for all staff 
performing delegated study-specific tasks. 
At a minimum, the training will consist of the following items: 
x
Clinical Investigation Plan (CIP) 
x
Informed consent process (covered by CIP training) 
x
Data collection tools 
x
Regulations 
Study center personnel participating in the clinical study will be trained in study activities relevant to their 
role. Training must be completed and documented prior to that individual conducting any study related 
activities. 
Investigator and/or study coordinator meeting(s) or telephone conference call(s) may be held to discuss 
the Clinical Investigation Plan (CIP), training, study results, etc. Continued training may occur through 
interim meetings or telephone conference calls to discuss relevant study issues. 

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14.5 Medtronic Representative Role 
Medtronic representatives may provide support as required for the study under the direct supervision of 
the principal Investigator as described below. The Principal Investigator or a person designated on the 
Delegation of Authority Log must be present to collect source documentation, record the study activities, 
and to be responsive to the subject’s needs during an activity performed by a Medtronic representative. 
Medtronic personnel may: 
x
Provide technical support during the procedure and follow-up visits 
x
This support may include the training of site personnel on the use of the Medtronic equipment or 
CIP-related procedures and data collection 
x
Clarify device behavior, operation, or diagnostic output as requested by the Principal Investigator 
or other health care professional 
x
Assist with the collection of technical data during the procedure (technical worksheets) 
Medtronic personnel may not: 
x
Practice medicine, provide medical diagnoses or make decisions related to subject treatment/care 
x
Express opinions about the product/feature under study 
x
Assist the subject by direct physical contact except as required by the specific protocol-related 
task to be conducted 
x
Discuss a subject’s condition or medical treatment with the subject or a member of the subjects’ 
family 
x
Provide the subject with any form/questionnaires related to the product(s) under investigation 
x
Enter data on eCRFs, except on the Medtronic Use Only Field 
15. Study Administration 
15.1 Site activation 
During the activation process (prior to subject enrollment), Medtronic will train site personnel on the 
Clinical Investigation Plan, relevant standards and regulations, informed consent process, and on data 
collection and reporting tools. If new members join the investigation site team afterwards, they will 
receive training on the applicable clinical study requirements relevant to their role before contributing to 
the clinical study. 

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Prior to performing study related activities, all local regulatory requirements shall be fulfilled, including, 
but not limited to the following:  
x
Ethics Committee approval (and voting list, as required by local law) of the current version 
of the CIP and Patient Informed Consent.  
x
Regulatory authority approval or notification (as required per local law)  
x
Fully executed Clinical Trial Agreement (CTA)  
x
Financial Disclosure  
x
Curriculum Vitae of Investigators and key members of the investigation site team (as 
required by local law)  
x
Documentation of delegated tasks 
x
Documentation of study training 
Medtronic will provide each study center with documentation of investigation site/Investigator readiness; 
this letter must be received prior to subject enrollment. 
15.2 Monitoring  
Monitoring visits will be conducted at the start, during and at the closure of the clinical study in 
accordance with Medtronic SOPs and the monitoring plan. The sponsor will adhere to the monitoring plan 
which contains the strategy for frequency of monitoring visits and source data verification to be 
performed for this study. Medtronic is responsible for ensuring the proper conduct of this study in terms 
of adherence to applicable regulations, protocol compliance, and the validity and accuracy of the study 
data entered on eCRFs. The Principal Investigator and site personnel will provide the Medtronic monitor(s) 
with complete access to primary source data (e.g., paper and electronic hospital/clinical charts, 
appointment books, laboratory records) that support the data on the eCRFs as well as other 
documentation supporting the conduct of the study. The monitor will perform source data verification 
and routine reviews of study-related regulatory documents during scheduled monitoring visits and work 
to secure compliance should any deficiencies be observed. Monitoring frequency may be increased if 
there are changes in study center personnel (to allow for training and additional sponsor oversight), a 
protocol amendment/safety issue that significantly affects study procedures or design, a documented or 
suspected lack of study compliance or Investigator oversight, or an issue with recruitment or enrollment.  
15.3 Data Management 
Medtronic personnel will perform routine edit and consistency checks for items such as missing data or 
inconsistent data. Identified data inconsistencies will be resolved by use of data discrepancies; 
Investigators and site personnel will review data discrepancies and respond to the discrepancies in a 
timely manner. The resolved discrepancy will become a part of the eCRF record for the subject. 

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The Oracle Clinical Remote Data Capture (RDC) system which is 21CFR§11 Part E compliant controls user 
access and ensures data integrity. This system is a fully validated system. The RDC system maintains an 
audit trail of entries, changes or corrections in eCRFs. User access will be granted to each individual based 
on his or her delegation of authority and completion of required training. If a person only authorized to 
complete eCRFs makes changes to an already signed eCRF, the system will require the Principal 
Investigator, or authorized Sub-Investigator, to re-sign the eCRF.  
The Principal Investigator, or designated Sub-Investigator, is responsible for the data submitted and must 
review all data for accuracy and provide his/her approval of the eCRF and sign each form with an electronic 
signature. 
15.4 Direct Access to Source Data/Documents  
The Investigator(s)/institution(s) will permit study-related monitoring, audits, EC review, and regulatory 
inspection(s), providing direct access to source data/documents. 
Medtronic or third-party auditors representing Medtronic may perform Quality Assurance audits to verify 
the performance of the monitoring process and study conduct, and to ensure compliance with applicable 
regulations. Representatives for regulatory bodies such as the FDA may also perform site inspections 
related to this clinical study. The Principal Investigator, site personnel, and institution will provide auditors 
with direct access to primary source data and all study-related documentation. 
Medtronic will investigate, and report suspected cases of fraud or misconduct as appropriate.  
15.5 Confidentiality 
Subject confidentiality will be maintained throughout the clinical study to the extent permitted by law. 
That is, every attempt will be made to remove subject identifiers from clinical study documents. For this 
purpose, a unique subject identification code (site number and subject number) will be assigned and used 
to allow identification of all data reported for each subject. This will also ensure that the information can 
be tracked back to the source data. 
The sponsor, Medtronic, will collect this key-coded data and monitor study records. Third parties e.g. 
auditors, ECs, Governmental regulatory authorities may also have access to the study records. 
Participating patients will not be identified by name in any published reports about this study. 
15.6 Liability 
Medtronic Bakken Research Center BV is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate clinical study liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 
insurance coverage. If required, a clinical study insurance statement/certificate will be provided to the EC, 
and/or the governing regulatory authority (if applicable).  

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15.7 CIP Amendments 
Protocol amendments may be initiated by Medtronic to address changes to the conduct of the study. 
Protocol amendments must be approved by Medtronic and submitted to the ECs and the governing 
regulatory authority (if required); protocol amendment approval and approval of any associated changes 
to the informed consent document must be obtained prior to implementation of the amendment except: 
x
When necessary to eliminate an immediate/or apparent immediate hazard to participating 
subjects 
x
When the change involves purely administrative or logistical aspects of the study 
15.8 Record Retention 
The Investigator or the medical institution where the study was conducted must retain the Investigator 
Site File, patient medical files and CRFs in accordance with local law and regulations for a minimum period 
of 5 years (or longer if local laws require) after study completion. The Investigator or the medical 
institution where the study was conducted should take measures to prevent accidental or early 
destruction of the clinical study related materials. 
Medtronic will retain the study records according to Medtronic policy. 
15.9 Publication and Use of Information 
Medtronic intends to publish the results from the FNS study in a timely manner as data become available. 
These publication activities may include abstracts, presentations/posters to scientific meetings, and 
manuscripts. 
Investigators who gathered data for this study (i.e., enrolled subjects and complied with the protocol) may 
be asked to write or contribute to the writing of abstracts and manuscripts based on the results of this 
study. Principal Investigators who meet the study-specific criteria above will be considered for 
abstract/manuscript authorship if they meet the International Committee of Medical Journal Editors, 
Ethical Considerations in the Conduct and Reporting of Research criteria available via the following link: 
http://www.icmje.org. Specifically, authorship credit should be based on the following and should meet 
all criteria listed below: 
x
Substantial contributions to conception or design; or the acquisition, analysis and interpretation 
of data for the work; 
x
Drafting the article or revising it critically for important intellectual content;  
x
Final approval of the version to be published; and 

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x
Agreement to be accountable for all aspects of the work in ensuring that questions related to the 
accuracy or integrity of any part of the work are appropriately investigated and resolved. 
Medtronic employees who meet the International Committee of Medical Journal Editors criteria for 
authorship will have the right to authorship. 
All contributors who do not meet the criteria for authorship are to be listed in an acknowledgments 
section according to the guidelines of the applicable scientific journal. Examples of those who might be 
acknowledged include a person who provided purely technical help, writing assistance, or a department 
chair that provided only general support. 
Before publication of any study-related data, the following guidelines will apply: 
x
Investigators are obligated to provide Medtronic with an opportunity to review any publication 
developed from data derived from this study. 
x
Medtronic will not financially compensate health care professionals (HCPs) or health care 
organizations (HCOs) for writing or editing activities on scientific publications related to research 
sponsored by Medtronic. 
15.10 Suspension or Early Termination 
Medtronic reserves the right to suspend or terminate the study at any time. Reasons may include, but are 
not limited to, the following: 
x
Insufficient enrollment to complete the study within the expected timeframe 
x
Identification of unacceptable safety profile; suspicion of an unacceptable risk will result in a 
suspension, confirmation of an unacceptable risk will result in termination 
x
If a death occurs attributable to the FNS cement, the study will be terminated. 
x
Product performance/product supply issues 
x
EC or governing regulatory authority (if applicable) suspension and/or termination of the study 
Medtronic reserves the right to suspend or terminate the study at an individual site. Reasons may include, 
but are not limited to, the following: 
x
Noncompliance with the protocol 
x
Serious or repeated deviations at the site 
x
Failure to implement required corrective and preventive actions 
x
Insufficient enrollment to complete the study within the expected timeframe 

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x
Loss of appropriately trained site personnel 
Investigators are required to notify the EC of study suspension/termination. Subjects will be notified by 
the Investigator of suspension/termination due to unacceptable risk or of termination due to any other 
cause. 
If, for any reason, Medtronic suspends or prematurely terminates the investigation at an individual 
investigation site, Medtronic shall inform the responsible regulatory authority as appropriate and ensure 
that the EC is notified, either by the Principal Investigator or by Medtronic. If the suspension or premature 
termination was in the interest of safety, Medtronic shall inform all other Principal Investigators and 
investigational sites. The Principal Investigator or authorized designee shall promptly inform the enrolled 
subjects at his/her investigation site, if appropriate. 
16. References 
1. 
Wittenberg, R.H., et al., Importance of bone mineral density in instrumented spine fusions. Spine 
(Phila Pa 1976), 1991. 16(6): p. 647-52. 
2. 
Halvorson, T.L., et al., Effects of bone mineral density on pedicle screw fixation. Spine (Phila Pa 
1976), 1994. 19(21): p. 2415-20. 
3. 
Chin, D.K., et al., Prevalence of osteoporosis in patients requiring spine surgery: incidence and 
significance of osteoporosis in spine disease. Osteoporos Int, 2007. 18(9): p. 1219-24. 
4. 
Becker, S., et al., Assessment of different screw augmentation techniques and screw designs in 
osteoporotic spines. Eur Spine J, 2008. 17(11): p. 1462-9. 
5. 
Pare, P.E., et al., Biomechanical evaluation of a novel fenestrated pedicle screw augmented with 
bone cement in osteoporotic spines. Spine (Phila Pa 1976), 2011. 36(18): p. E1210-4. 
6. 
Chang, M.C., C.L. Liu, and T.H. Chen, Polymethylmethacrylate augmentation of pedicle screw for 
osteoporotic spinal surgery: a novel technique. Spine (Phila Pa 1976), 2008. 33(10): p. E317-24. 
7. 
Sawakami, K., et al., Polymethylmethacrylate augmentation of pedicle screws increases the initial 
fixation in osteoporotic spine patients. J Spinal Disord Tech, 2012. 25(2): p. E28-35. 
8. 
Janssen, I., et al., Risk of cement leakage and pulmonary embolism by bone cement-augmented 
pedicle screw fixation of the thoracolumbar spine. Spine J, 2017. 
9. 
Akinola, B., et al., Pulmonary cement embolism during cement augmentation of pedicle screw 
fixation: a case report. J Orthop Surg (Hong Kong), 2010. 18(3): p. 364-6. 
10. 
Dai, F., et al., Surgical treatment of the osteoporotic spine with bone cement-injectable cannulated 
pedicle screw fixation: technical description and preliminary application in 43 patients. Clinics (Sao 
Paulo), 2015. 70(2): p. 114-9. 

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11. 
Hu, M.H., et al., Polymethylmethacrylate augmentation of the pedicle screw: the cement 
distribution in the vertebral body. Eur Spine J, 2011. 20(8): p. 1281-8. 
12. 
Lubansu, A., et al., Minimally invasive spinal arthrodesis in osteoporotic population using a 
cannulated and fenestrated augmented screw: technical description and clinical experience. 
Minim Invasive Surg, 2012. 2012: p. 507826. 
13. 
Pinera, A.R., et al., Instrumented lumbar arthrodesis in elderly patients: prospective study using 
cannulated cemented pedicle screw instrumentation. Eur Spine J, 2011. 20 Suppl 3: p. 408-14. 
14. 
Moon, B.J., et al., Polymethylmethacrylate-augmented screw fixation for stabilization of the 
osteoporotic spine : a three-year follow-up of 37 patients. J Korean Neurosurg Soc, 2009. 46(4): p. 
305-11. 
15. 
Mueller, J.U., et al., Cement leakage in pedicle screw augmentation: a prospective analysis of 98 
patients and 474 augmented pedicle screws. J Neurosurg Spine, 2016. 25(1): p. 103-9. 
16. 
Girardo, M., et al., Surgical treatment of osteoporotic thoraco-lumbar compressive fractures: the 
use of pedicle screw with augmentation PMMA. Eur Spine J, 2017. 
17. 
Guan, H., et al., Early or delayed operation, which is more optimal for kyphoplasty? A retrospective 
study on cement leakage during kyphoplasty. Injury, 2012. 43(10): p. 1698-703. 
18. 
Lee, I.J., et al., CT evaluation of local leakage of bone cement after percutaneous kyphoplasty and 
vertebroplasty. Acta Radiol, 2010. 51(6): p. 649-54. 
19. 
Amendola, L., et al., Fenestrated pedicle screws for cement-augmented purchase in patients with 
bone softening: a review of 21 cases. J Orthop Traumatol, 2011. 12(4): p. 193-9. 
20. 
Chandra, V.V., et al., Segmental polymethylmethacrylate-augmented fenestrated pedicle screw 
fixation for lumbar spondylolisthesis in patients with osteoporosis - A case series and review of 
literature. Neurol India, 2017. 65(1): p. 89-95. 
21. 
Triebel, J., et al., Women do not fare worse than men after lumbar fusion surgery - Two-year 
follow-up results from 4,780 prospectively collected patients in the Swedish National Spine 
Register with lumbar degenerative disc disease and chronic low back pain. Spine J, 2017. 17(5):p. 
656-662.  
22. 
Dimar, J.R., et al., Clinical and radiographic analysis of an optimized rhBMP-2 formulation as an 
autograft replacement in posterolateral lumbar spine arthrodesis. J Bone Joint Surg Am, 
2009.91(6):p. 1377-1386. 
23. 
Fairbank, J.C. and P.B. Pynsent, The Oswestry Disability Index. Spine (Phila Pa 1976), 2000. 25(22): 
p. 2940-52; discussion 2952. 
24. 
Kind, P., The EuroQol instrument: an index of health-related quality of life, in Quality of Life and 
Pharmacoeconomics in Clinical Trials. 1996. p. 191-201. 

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25. 
Schwab F., Scoliosis Research Society - Schwab Adult Spinal Deformity Classification. Spine (Phila 
Pa 1976), 2012. 37(12): p. 1077-82. 
26.  
Damilakis J., Radiation exposure in X-ray-based imaging techniques used in osteoporosis. Eur 
Radiol, 2010. 20(11):p.2707-2714.  
17. Appendices  
17.1 Sponsor contact information 
Detailed sponsor contact information not outlined in the Clinical Investigational Plan will be provided 
under a separate cover. 
17.2 Participating Investigators and Investigation Sites 
At the time of completion of the FNS study Clinical Investigation Plan, site selection is not yet complete. 
Therefore, a complete list of names, addresses, and professional positions of the clinical Investigators and 
clinical investigation sites will be distributed under a separate cover when available. 
18. Version History 
Version 
Summary of Changes 
Author(s)/Title 
1.0, 1 AUG 2018 
x
Initial release 
Ellen Konings, Clinical Study
Manager 
2.0, 19 SEP 2018  3. SYNOPSYS 
x
Page 8 (page 8 in CIP v1.0):  The 
sentence “one of the following 
indications” has been replaced with 
“one or more of the following 
diagnostic indications”.  
x
Page 8 and 10, (page 8 and 10 in CIP 
v1.0): scoliosis, kyphosis and lordosis 
have 
been 
removed 
from 
the 
examples of deformity indications. 
x
Page 10 (page 10 in CIP v1.0): The 
sentence “one of the following 
Beatrice C. Sicurella, Clinical Study 
Manager 

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diagnostic 
indications” has 
been 
replaced with “one or more of the 
following diagnostic indications”.  
x
Page 11 (page 11 in CIP v1.0): the 
sentence “Has documented allergy to 
the instrumentation materials that will 
be used for the procedure (e.g. 
titanium 
alloys, 
cobalt-chromium-
molybdenum 
alloys 
and 
PMMA 
Fenestrated Screw Cement)” has been 
changed to “Has documented allergy 
to the materials that will be used in the 
surgical or any imaging procedure 
(e.g. 
titanium 
alloys, 
cobalt-
chromium-molybdenum alloys, PMMA 
Fenestrated Screw Cement, contrast 
medium). 
 
7.0 PRODUCT DESCRIPTION 
x
Page 20 (page 20 in CIP version 1.0): 
“polymethymethacrylate” has been 
corrected 
to 
“polymethylmethacrylate”. 
 
8.0 SELECTION OF SUBJECTS 
x
Page 23 and 24 (page 23 and 24 in CIP 
v1.0): scoliosis, kyphosis and lordosis 
have 
been 
removed 
from 
the 
examples of deformity indications. 
x
Page 23 (page 23 in CIP version 1.0): 
The sentence “one of the following 
conditions” has been replaced with 

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“one or more of the following 
conditions”. 
x
Page 25 (page 25 in CIP v1.0): the 
sentence “Has documented allergy to 
the instrumentation materials that will 
be used for the procedure (e.g. 
titanium 
alloys, 
cobalt-chromium-
molybdenum 
alloys 
and 
PMMA 
Fenestrated Screw Cement)” has been 
changed to “Has documented allergy 
to the materials that will be used in the 
surgical or any imaging procedure 
(e.g. 
titanium 
alloys, 
cobalt-
chromium-molybdenum alloys, PMMA 
Fenestrated Screw Cement, contrast 
medium).