Transforaminal/Posterior Lumbar Interbody Fusion With the FlareHawk® Expandable Interbody Fusion Device: A Retrospective Chart Review Study
Conditions: Degenerative Disc Disease
Sponsor: Integrity Implants Inc.

Transforaminal/Posterior Lumbar Interbody Fusion  
with the  
FlareHawk® Expandable Interbody Fusion Device:  
A Retrospective Chart Review Study 
 
NCT04057235 
 
November 15, 2019 

 
 
 
 
 
Clinical Protocol 
Transforaminal/Posterior Lumbar Interbody Fusion with 
the FlareHawk® Expandable Interbody Fusion Device: 
A Retrospective Chart Review Study 
Doc: CP-00001 
Rev C  
  Page 1 of 6 
1. PURPOSE: 
1.1. This retrospective study will evaluate the clinical outcomes of patients who have 
undergone a TLIF or PLIF procedure with a FlareHawk expandable interbody fusion 
cage(s) to assess the device’s performance and safety when used in accordance with its 
intended use. 
2. SCOPE:   
2.1. This study will include patients who underwent 1 or 2 contiguous level TLIF or PLIF 
procedure with the FlareHawk expandable interbody fusion cage. A total of at least 100 
patients from at least three sites will be enrolled based on inclusion/exclusion criteria. 
3. REFERENCES:   
3.1. EN ISO 14155, Clinical investigation of medical devices for human subjects - Good 
clinical practice 
3.2. CER-00001, FlareHawk Interbody Fusion System Clinical Evaluation Report 
3.3. MEDDEV 2.7/1 rev.4, Clinical evaluation: Guide for manufacturers and notified bodies 
3.4. Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K: Anterior fresh frozen structural 
allografts in the thoracic and lumbar spine. Do they work if combined with posterior 
fusion and instrumentation in adult patients with kyphosis or anterior column defects? 
Spine (Phila Pa 1976) 20:1410–1418, 1995 
3.5. Noshchenko A, Hoffecker L, Lindley EM, Burger EL, Cain CM, Patel VV. Long-term 
Treatment Effects of Lumbar Arthrodeses in Degenerative Disk Disease: A Systematic 
Review With Meta-Analysis. J Spinal Disord Tech. 2015;28(9):E493-521 
3.6. Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and 
functional status in low back pain: towards international consensus regarding minimal 
important change. Spine. 2008;33(1):90-4 
3.7. Yavin D, Casha S, Wiebe S, et al. Lumbar Fusion for Degenerative Disease: A Systematic 
Review and Meta-Analysis. Neurosurgery. 2017; 80(5):701-715 
 
 

 
 
 
 
 
Clinical Protocol 
Transforaminal/Posterior Lumbar Interbody Fusion with 
the FlareHawk® Expandable Interbody Fusion Device: 
A Retrospective Chart Review Study 
Doc: CP-00001 
Rev C  
  Page 2 of 6 
4. METHODS/PROCEDURE:   
4.1. Study Hypothesis 
The primary hypothesis is that study subjects who received the FlareHawk expandable 
cage(s) through a TLIF or PLIF procedure experienced fusion by 12 months (+/- 3 mo) 
follow-up, with improvements in clinical outcomes related to pain and/or disability 
compared to pre-operative scores. Further, the subjects are hypothesized to have not 
experienced any unforeseen device- or procedure-related adverse events 
4.2. Primary Outcome 
Proportion of subjects with radiographic arthrodesis at 12 months +/- 3 months as 
determined using plain radiographic images with assessment based on the Bridwell-
Lenke grading system [Bridwell and Lenke et al, 1995]. 
4.3. Secondary Outcomes 
• Change in VAS Leg from preoperative baseline to 12 months +/- 3 months 
• Change in VAS Back from preoperative baseline to 12 months +/- 3 months 
• Change in Oswestry Disability Index (ODI) from baseline to 12 months +/- 3 months 
• Intra-operative and post-operative adverse events 
4.4. Study Population 
A total of at least 100 patients from at least three sites will be enrolled based on 
inclusion/exclusion criteria. Homogeneity of data collection and treatment procedures 
will be ensured prior to combining data from multiple sites. The retrospective chart 
review will include the full consecutive series of patients who received TLIF or PLIF 
surgery using the FlareHawk expandable interbody fusion cage between December 1, 
2017, and May 31, 2018. Subjects from that consecutive series will be included in the 
study based on the pre-defined inclusion and exclusion criteria. If at least 100 patients 
are not included after screening through the pre-defined inclusion / exclusion criteria, 
the date range will be extended, and the full consecutive series of patients within the 
new date range will be considered for inclusion. The date range will be extended, as 
necessary, until at least 100 patients are included. All subjects will have been diagnosed 
with degenerative disc disease of the lumbar spine that required lumbar interbody 
fusion procedure at one or two levels as per the opinion of the treating surgeon. All 

 
 
 
 
 
Clinical Protocol 
Transforaminal/Posterior Lumbar Interbody Fusion with 
the FlareHawk® Expandable Interbody Fusion Device: 
A Retrospective Chart Review Study 
Doc: CP-00001 
Rev C  
  Page 3 of 6 
subjects who meet the inclusion criteria and do not meet any of the exclusion criteria 
will be included in the study.   
4.5. Study Procedure 
Refer to Attachment A for the detailed study protocol. 
5. WORST CASE RATIONALE: 
5.1. Not applicable 
6. SAMPLE SIZE:   
6.1. The primary outcome of this study, radiographic arthrodesis, is commonly observed in 
approximately 80-100% of study subjects for TLIF/PLIF surgeries [FlareHawk CER-00001 
Rev C]. With 100 subjects included, if an 88% fusion rate is observed, the 95% 
confidence interval for fusion success will be 80.2%-93.0%, placing the performance 
results within the anticipated range. Further, the inclusion of at least 100 subjects will 
enable the likely detection of adverse events that have a probability of occurrence of at 
least 1.6%, assuming a power of 80% [MedDev 2.7.1, rev 4]. This detection rate is 
adequate for this device and study based on the severity and frequency of anticipated 
adverse events associated with the FlareHawk device [FlareHawk CER-00001 Rev C]. 
The target sample size for inclusion will be 118 patients, assuming that up to 15% will 
not have data at the 12 months follow-up, yielding at least 100 patients with data.  
7. ACCEPTANCE CRITERIA:   
7.1. Inclusion Criteria 
Subjects must meet all of the inclusion criteria to be included in this study.  
To be a part of this study, the subject must: 
• Have been at least 18 years of age and skeletally mature at the time of surgery 
• Have had clinical and radiological evidence of degenerative disc disease of the 
lumbar spine 
• Have been treated with PLIF or TLIF surgery using the FlareHawk expandable 
interbody cage(s) at 1 or 2 contiguous levels from L2 to S1 

 
 
 
 
 
Clinical Protocol 
Transforaminal/Posterior Lumbar Interbody Fusion with 
the FlareHawk® Expandable Interbody Fusion Device: 
A Retrospective Chart Review Study 
Doc: CP-00001 
Rev C  
  Page 4 of 6 
• Have been treated using the FlareHawk expandable interbody fusion cage, 
according to the approved labeling, between December 1, 2017, and May 31, 2018 
7.2. Exclusion Criteria 
Subjects must not meet any of the following exclusion criteria to be included in the 
study: 
• Have a history of fusion surgery at the study level(s) prior to treatment with the 
FlareHawk device(s) 
• Have had spondylolisthesis unable to be reduced to grade 1 as part of the surgical 
procedure  
• Have had surgery with the FlareHawk device(s) at more than 2 levels 
• Have had surgery with the FlareHawk device(s) at levels outside the range of L2 to 
S1  
• Have been treated with any bone grafting material other than autogenous or 
allogenic bone graft in the FlareHawk device(s) and surrounding disc space 
• Have any contraindications listed in the approved labeling  
8. PERSONNEL/EQUIPMENT:   
8.1. Proposed Study Site List 
8.1.1. Carolina Neurosurgery & Spine Associates, Charlotte, NC 
    Principal Investigator: Domagoj Coric MD  
8.1.2. NYU Langone Health, New York NY 
    Principal Investigator: Jeffrey A Goldstein MD 
8.1.3. Northeast Ohio Spine Center, Akron, OH 
    Principal Investigator: Mark Grubb MD 
8.1.4. Chatham Orthopaedic Associates, Savannah GA 
    Principal Investigator: Raphael R Roybal MD 
8.2. Clinical Research Organization 
8.2.1. Telos Partners LLC, Lakeland, FL 

 
 
 
 
 
Clinical Protocol 
Transforaminal/Posterior Lumbar Interbody Fusion with 
the FlareHawk® Expandable Interbody Fusion Device: 
A Retrospective Chart Review Study 
Doc: CP-00001 
Rev C  
  Page 5 of 6 
8.3. Institutional Review Board 
8.3.1. WIRB (Western Institutional Review Board), Puyallup, WA 
9. DATA ANALYSIS: 
9.1. Primary Outcome 
The proportion of levels achieving arthrodesis at 12 months (+/- 3 months) will be 
summarized as a percentage and 95% confidence interval, based on the Wilson score 
method for binomial confidence intervals.Integrity Implants engineering to determine if 
the criteria for success was met.  
9.2. Secondary Outcomes 
Continuous variables, such as baseline demographics and change in patient-reported 
outcomes from preoperative baseline to 12 months, will be summarized using mean, 
standard deviation, minimum and maximum values. Paired t-test or a non-parametric 
equivalent (if data does not satisfy assumptions of normality) will be used to determine 
if changes in VAS or ODI scores are statistically significant from preoperative baseline to 
12 months (+/- 3 months) follow-up. Responder analyses for changes in patient-
reported outcomes at 12 months (+/- 3 months) will be conducted using minimum 
clinically important differences (MCID). Significant clinical improvements from 
preoperative baseline to 12 months (+/- 3 months) follow-up will be determined on a 
per-patient basis using the following MCID values: 
• Improvement in ODI ≥ 10 points [Ostelo et al. 2008] 
• Improvement in VAS leg pain ≥ 15 points [Ostelo et al. 2008] 
• Improvement in VAS back pain ≥ 15 points [Ostelo et al. 2008] 
The proportion of patients with improvements exceeding the MCID values will be 
summarized as a percentage and 95% confidence interval. 
Sub-group analyses will be performed based on the implant version (split-shim vs. 
“Version B”), history of previous surgery at the index level, patient co-morbidities, and 
demographic variables. 
For any adverse events, the observed rate of each type of event will be summarized as 
a percentage with the 95% confidence interval and compared with rates observed in 

 
 
 
 
 
Clinical Protocol 
Transforaminal/Posterior Lumbar Interbody Fusion with 
the FlareHawk® Expandable Interbody Fusion Device: 
A Retrospective Chart Review Study 
Doc: CP-00001 
Rev C  
  Page 6 of 6 
the literature describing the current state of the art with other PLIF and TLIF interbody 
cages. 
10. ATTACHMENTS: 
Attachment A -   Clinical Investigation Plan, Transforaminal/Posterior Lumbar Interbody 
Fusion with the FlareHawk® Expandable Interbody Fusion Device: 
A Retrospective Chart Review Study, Protocol Date July 18, 2019, V1 
Attachment B -  FlareHawk Retrospective Study Case Report Forms 
 

 
 
Clinical Investigational Plan 
 
 
 
 
 
 
 
Transforaminal/Posterior Lumbar Interbody Fusion with the  
FlareHawk® Expandable Interbody Fusion Device: 
 A Retrospective Chart Review Study 
 
 
 
 
 
Protocol Date:   July 18, 2019 
 
 
 
 
 
 
Sponsor 
 
Integrity Implants Inc.  
354 Hiatt Drive 
Palm Beach Gardens, Florida 33418 USA 
 
 
 
 
 
 

Protocol date July 18, 2019 
V1 
Page 3 
 
 
Investigator Protocol Approval Page 
 
 
Study Title: 
Transforaminal/Posterior Lumbar Interbody Fusion with the  
FlareHawk® Expandable Interbody Fusion Device: 
 A Retrospective Chart Review Study 
 
Short Title:    
 
Integrity Implants FlareHawk® Study 
 
Principal Investigator: Domagoj Coric MD 
 
Co-Investigators: 
Not Applicable 
 
Study Site:   
Carolina Neurosurgery & Spine Associates, Charlotte, NC 
 
Protocol Date: 
 
July 18, 2019 
 
 
The signature of the investigator below constitutes approval of this protocol and provides the necessary assurances that this 
Outcomes Study will be conducted according to Good Clinical Practices and to all stipulations, clinically and administratively, 
as stated in the protocol, including all statements as to confidentiality. 
It is agreed that the protocol contains all necessary information required to conduct the Outcomes Study as outlined in the 
protocol.  
 
PRINCIPAL INVESTIGATOR: 
 
__________________________________ 
Print Name 
 
__________________________________ 
 
______________________ 
Signature 
 
 
 
 
 
Date 
 

Protocol date July 18, 2019 
V1 
Page 3 
 
 
Investigator Protocol Approval Page 
 
 
Study Title: 
Transforaminal/Posterior Lumbar Interbody Fusion with the  
FlareHawk® Expandable Interbody Fusion Device: 
 A Retrospective Chart Review Study 
 
Short Title:    
 
Integrity Implants FlareHawk® Study 
 
Principal Investigator: Jeffrey A Goldstein MD 
 
Co-Investigators: 
Aaron J Buckland MD 
 
Study Site:   
NYU Langone Health, New York NY 
 
Protocol Date: 
 
July 18, 2019 
 
 
The signature of the investigator below constitutes approval of this protocol and provides the necessary assurances that this 
Outcomes Study will be conducted according to Good Clinical Practices and to all stipulations, clinically and administratively, 
as stated in the protocol, including all statements as to confidentiality. 
It is agreed that the protocol contains all necessary information required to conduct the Outcomes Study as outlined in the 
protocol.  
 
PRINCIPAL INVESTIGATOR: 
 
__________________________________ 
Print Name 
 
__________________________________ 
 
______________________ 
Signature 
 
 
 
 
 
Date 
 

Protocol date July 18, 2019 
V1 
Page 3 
 
 
Investigator Protocol Approval Page 
 
 
Study Title: 
Transforaminal/Posterior Lumbar Interbody Fusion with the  
FlareHawk® Expandable Interbody Fusion Device: 
 A Retrospective Chart Review Study 
 
Short Title:    
 
Integrity Implants FlareHawk® Study 
 
Principal Investigator: Mark Grubb MD 
 
Co-Investigators: 
Not Applicable 
 
Study Site:   
Northeast Ohio Spine Center, Akron, OH 
 
Protocol Date: 
 
July 18, 2019 
 
 
The signature of the investigator below constitutes approval of this protocol and provides the necessary assurances that this 
Outcomes Study will be conducted according to Good Clinical Practices and to all stipulations, clinically and administratively, 
as stated in the protocol, including all statements as to confidentiality. 
It is agreed that the protocol contains all necessary information required to conduct the Outcomes Study as outlined in the 
protocol.  
 
PRINCIPAL INVESTIGATOR: 
 
__________________________________ 
Print Name 
 
__________________________________ 
 
______________________ 
Signature 
 
 
 
 
 
Date 
 

Protocol date July 18, 2019 
V1 
Page 3 
 
 
Investigator Protocol Approval Page 
 
 
Study Title: 
Transforaminal/Posterior Lumbar Interbody Fusion with the  
FlareHawk® Expandable Interbody Fusion Device: 
 A Retrospective Chart Review Study 
 
Short Title:    
 
Integrity Implants FlareHawk® Study 
 
Principal Investigator: Raphael R Roybal MD 
 
Co-Investigators: 
Not Applicable 
 
Study Site:   
Chatham Orthopaedic Associates, Savannah GA 
 
Protocol Date: 
 
July 18, 2019 
 
 
The signature of the investigator below constitutes approval of this protocol and provides the necessary assurances that this 
Outcomes Study will be conducted according to Good Clinical Practices and to all stipulations, clinically and administratively, 
as stated in the protocol, including all statements as to confidentiality. 
It is agreed that the protocol contains all necessary information required to conduct the Outcomes Study as outlined in the 
protocol.  
 
PRINCIPAL INVESTIGATOR: 
 
__________________________________ 
Print Name 
 
__________________________________ 
 
______________________ 
Signature 
 
 
 
 
 
Date 
 

Protocol date July 18, 2019 
V1 
Page 4 
 
 
 
 
 
 
Table of Contents 
 
 
Sponsor Protocol Approval Page  
 
 
 
 
 
 
2 
Investigator Protocol Approval Page 
 
 
 
 
 
 
3 
Table of Contents 
 
 
 
 
 
 
 
 
4 
Study Summary  
 
 
 
 
 
 
 
 
5 
Introduction (1)  
 
 
 
 
 
 
 
 
6 
Background (1.1) 
 
 
 
 
 
 
            
6 
Device Description (1.2)  
 
 
 
 
 
 
 
6 
Purpose of the Study (2)  
 
 
 
 
 
 
 
7 
Study Design (3) 
 
 
 
 
 
 
 
 
7 
Study Hypothesis (3.1)  
 
 
 
 
 
 
 
7 
Study Description (3.2)  
 
 
 
 
 
 
 
7 
Primary Outcome (3.3)  
 
 
 
 
 
 
 
7 
Secondary Outcomes (3.4) 
 
 
 
 
 
 
 
7 
Study Population (3.5)  
 
 
 
 
 
 
 
7 
Sample Size Justification (3.6)  
 
 
 
 
 
 
8 
Proposed Study Site List and Justification (3.7)  
 
 
 
 
8 
Subject Eligibility Criteria (3.8) 
 
 
 
 
 
 
 
9 
Inclusion Criteria (3.9)  
 
 
 
 
 
 
 
9 
 
Exclusion Criteria (3.10)  
 
 
 
 
 
 
 
10 
Study Procedure (4) 
 
 
 
 
 
 
 
 
10 
Subject Chart Review (4.1) 
 
 
 
 
 
 
 
10 
Data Collection Procedure (4.2)  
 
 
 
 
 
 
10 
Data to be Collected (4.3) 
 
 
 
 
 
 
 
11 
Data Management Plan (4.4) 
 
 
 
 
 
 
 
13 
Monitoring Plan (4.5) 
 
 
 
 
 
 
 
 
13 
Adverse Events (5) 
 
 
 
 
 
 
 
 
13  
Subject Safety (5.1) 
 
 
 
 
 
 
 
 
14 
Mitigation of Risks (5.2)  
 
 
 
 
 
 
 
14 
Image and Data Analysis (6) 
 
 
 
 
 
 
 
15 
Radiographic Fusion Assessment (6.1)  
 
 
 
 
 
15 
Data Analysis (6.2) 
 
 
 
 
 
 
 
 
15 
Ethical and Regulatory Requirements (7)  
 
 
 
 
 
16 
Code of Conduct (7.1)  
 
 
 
 
 
 
 
16 
Subject Confidentiality (7.2) 
 
 
 
 
 
 
 
16 
Retention of Records by Investigator (7.3) 
 
 
 
 
 
16 
References (8)  
 
 
 
 
 
 
 
 
16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
       

Protocol date July 18, 2019 
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Integrity Implants Study Summary 
 
 
Study Title:  
Transforaminal/Posterior Lumbar Interbody Fusion with the  
FlareHawk® Expandable Interbody Fusion Device: 
A Retrospective Chart Review Study  
Study Design:   
Retrospective study – chart review 
 
 
Study Purpose:    
To evaluate the clinical outcomes of patients undergoing transforaminal or 
posterior lumbar interbody fusion (TLIF or PLIF) procedures using a 
FlareHawk expandable interbody fusion cage 
 
 
Study Population:  
Patients who underwent 1 or 2 contiguous level TLIF or PLIF procedure with 
the FlareHawk expandable interbody fusion cage. A total of at least 100 
patients from at least three sites will be enrolled based on inclusion/exclusion 
criteria. 
 
Minimum Follow-up: 
12 months +/- 3 months 
 
Primary Outcome:  
Proportion of subjects with radiographic arthrodesis at  
12 months +/- 3 months 
 
 
Secondary Outcomes:  
 
• Change in VAS Leg pain from preoperative baseline to 12 months  
+/- 3 months 
• Change in VAS Back pain from preoperative baseline to 12 months  
+/- 3 months 
• Change in Oswestry Disability Index (ODI) from preoperative baseline to  
12 months +/- 3 months 
• Other intra-operative or post-operative adverse events 
  
 

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1.  Introduction 
1.1   Background 
Degenerative disc disease (DDD) of the lumbar spine is commonly defined by discogenic pain with degeneration of 
the disc confirmed by patient symptom history (e.g. back and lower extremity pain) and radiographic findings (e.g. 
disc space collapse and stenosis). DDD is sometimes accompanied by spondylolisthesis (vertebral “slipping”) of 
varying extent, with Grade I being the most mild. The most common therapies available for lumbar DDD are 
conservative care (e.g. injections, chiropractic manipulations), decompression without fusion, posterolateral fusion 
(PLF), or lumbar interbody fusion (LIF). With more than 6 months of failed conservative care, patients may be 
indicated for surgical intervention and LIF is often regarded as the mainstay of surgical care for degenerative disc 
disease [Noshchenko et al. 2015; Yavin et al. 2017]. Transforaminal lumbar interbody fusion (TLIF) and posterior 
lumbar interbody fusion (PLIF) are two variants of LIF surgery that utilize a posterior approach. 
More recently, expandable interbody cages have been introduced for use in TLIF or PLIF procedures. Expandable 
cages, in general, have the potential advantage of facilitating more minimally invasive surgery while achieving 
substantial disc height and neuroforaminal height restoration as well as lordosis. Designs that expand in the 
transverse plane (medially-laterally) may also reduce subsidence risk due to their larger footprint. The FlareHawk 
expandable interbody fusion cage offers a simple expansion mechanism to achieve biplanar (cranial-caudal and 
medial-lateral) expansion in situ. This device is currently FDA-cleared in the United States and has been adopted 
into standard clinical practice beginning in August 2016, with over 3800 devices implanted to date. This study is a 
retrospective chart review to assess the performance and safety of the FlareHawk expandable cage under its 
intended use. 
1.2   Device Description 
The Integrity Implants FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion 
device intended for use in the lumbosacral spine from L2-S1 and is intended for intervertebral lumbar fusion. The 
FlareHawk implant consists of a Shell and a Shim component that are offered in a range of sizes to accommodate 
variation in patient anatomy. The Shell component is a rectangular frame with struts on all four sides that allow for 
insertion into the intervertebral body space in a non-expanded form, and subsequent expansion following the 
insertion of the Shim component. The Shim component has a tapered front end that inserts into and expands the 
Shell component to the desired vertical and horizontal dimensions. When fully inserted, the Shim locks within the 
Shell to provide structural stability for interbody fusion. An integrated “Core” in the Shell serves to anchor the 
delivery instrument during Shim insertion. Protrusions on the superior and inferior surfaces of the implant grip the 
adjacent vertebral endplates to resist expulsion. The FlareHawk implant is to be filled with autogenous and/or 
allogenic bone graft composed of cancellous and/or corticocancellous bone. Once implanted, the FlareHawk 

Protocol date July 18, 2019 
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implant is designed to restore intervertebral disc height, provide anterior column support and maintain structural 
stability of the motion segment to facilitate intervertebral body fusion. 
 
2. Purpose of the Study:  
The purpose of this study is to evaluate the clinical outcomes of patients who have undergone a TLIF or PLIF 
procedure with a FlareHawk expandable interbody fusion cage(s) to assess the device’s performance and safety 
when used in accordance with its intended use. 
3.  Study Design 
3.1 Study Hypothesis: 
The primary hypothesis is that study subjects who received the FlareHawk expandable cage(s) through a TLIF or 
PLIF procedure experienced fusion by 12 months (+/- 3 mo) follow-up, with improvements in clinical outcomes 
related to pain and/or disability compared to pre-operative scores. Further, the subjects are hypothesized to have 
not experienced any unforeseen device- or procedure-related adverse events. 
3.2 Study Description:  
This is a retrospective clinical study (chart review) of patients who have previously undergone TLIF or PLIF surgery 
with the FlareHawk expandable interbody fusion cage at one or two contiguous levels.  
3.3 Primary Outcome: 
Proportion of subjects with radiographic arthrodesis at 12 months +/- 3 months as determined using plain 
radiographic images with assessment based on the Bridwell-Lenke grading system [Bridwell and Lenke et al, 1995].  
3.4 Secondary Outcomes: 
• Change in VAS Leg from preoperative baseline to 12 months +/- 3 months 
• Change in VAS Back from preoperative baseline to 12 months +/- 3 months 
• Change in Oswestry Disability Index (ODI) from baseline to 12 months +/- 3 months 
• Intra-operative and post-operative adverse events 
3.5 Study Population:  
A total of at least 100 patients from at least three sites will be enrolled based on inclusion/exclusion criteria. 
Homogeneity of data collection and treatment procedures will be ensured prior to combining data from multiple 
sites. The retrospective chart review will include the full consecutive series of patients who received TLIF or PLIF 
surgery using the FlareHawk expandable interbody fusion cage between December 1, 2017, and May 31, 2018. 
Subjects from that consecutive series will be included in the study based on the pre-defined inclusion and exclusion 

Protocol date July 18, 2019 
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criteria, detailed below. If at least 100 patients are not included after screening through the pre-defined inclusion / 
exclusion criteria, the date range will be extended, and the full consecutive series of patients within the new date 
range will be considered for inclusion. The date range will be extended, as necessary, until at least 100 patients are 
included. All subjects will have been diagnosed with degenerative disc disease of the lumbar spine that required 
lumbar interbody fusion procedure at one or two levels as per the opinion of the treating surgeon. All subjects who 
meet the inclusion criteria and do not meet any of the exclusion criteria will be included in the study.   
Two versions of the device have been on the market recently. The “Split Shim” version was introduced to the 
market in January 2018. This version supersedes the previous version, “Version B”, which has been on the market 
since January 2017. These two versions of the device have subtle differences and are equivalent from the clinical, 
technical, and biological perspective, and are expected to demonstrate equivalent safety and performance. 
Therefore, data will be collected from patients treated with either version of the device. A subgroup analysis will be 
performed to confirm poolability of the data. 
3.6 Sample Size Justification 
The primary outcome of this study, radiographic arthrodesis, is commonly observed in approximately 80-100% of 
study subjects for TLIF/PLIF surgeries [FlareHawk CER-00001 Rev C]. With 100 subjects included, if an 88% fusion 
rate is observed, the 95% confidence interval1 for fusion success will be 80.2%-93.0%, placing the performance 
results within the anticipated range. Further, the inclusion of at least 100 subjects will enable the likely detection of 
adverse events that have a probability of occurrence of at least 1.6%, assuming a power of 80% [MedDev 2.7.1, rev 
4]. This detection rate is adequate for this device and study based on the severity and frequency of anticipated 
adverse events associated with the FlareHawk device [FlareHawk CER-00001 Rev C]. The target sample size for 
inclusion will be 118 patients, assuming that up to 15% will not have data at the 12 months follow-up, yielding at 
least 100 patients with data. 
3.7 Proposed* Study Site List and Justification 
1. Carolina Neurosurgery & Spine Associates, Charlotte, NC 
Principal Investigator: Domagoj Coric MD 
Carolina Neurosurgery & Spine Associates is the largest neurosurgical group in the country, employing almost 
thirty (30) neurosurgeons across Charlotte and part of South Carolina.  Patient demographics range from 
simple degenerative to very complex adult deformity.  Dr. Coric has been the lead investigator or co-
investigator of many investigational products and is an authority on expandable spacers. He was an early 
pioneer using StaxxXD, the first commercially available expandable lumbar interbody device, and has 
                                                 
1 Based on the Wilson score method for binomial confidence intervals 
* Proposed sites are pending site qualifications and clinical trial agreements 

Protocol date July 18, 2019 
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collaborated with other companies, such as Globus, Stryker, and Expanding Orthopedics, on their expandable 
technologies.  Dr. Coric prefers PLIF over TLIF, as he has always been a proponent of maximum surface area 
for the most stable construct while being able to maximize graft delivery. 
2. NYU Langone Health, New York NY 
Principal Investigator: Jeffrey A Goldstein MD 
Dr. Goldstein is an NYU-based orthopedic surgeon in Manhattan, and is nationally recognized in several 
disciplines including MIS, artificial disc, and robotic surgery.  Dr. Goldstein’s cases vary from degenerative to 
complex adult deformity.  Dr. Goldstein uses a TLIF approach and will approach the spine MIS or Open based 
on the pathology.  Dr. Goldstein also has an interest in nerve health and is interested in devices that could 
potentially reduce nerve injuries when approaching the spine posteriorly.  
3. Northeast Ohio Spine Center, Akron, OH 
Principal Investigator: Mark Grubb MD 
Dr. Grubb is a private practice orthopedic surgeon, with a distinct focus on treating patients and pathology with 
minimally invasive surgeries.  Dr. Grubb is a respected surgeon teaching Kambin’s triangle approach both in 
the US and abroad.  Dr. Grubb prefers a TLIF approach.  Due to Dr. Grubb’s emphasis on minimally invasive 
techniques, he uses percutaneous pedicle screws for posterior fixation. 
4. Chatham Orthopaedic Associates, Savannah GA 
Principal Investigator: Raphael R Roybal MD 
Dr. Roybal is a private practice orthopedic surgeon. He represents the majority of orthopedic spine surgeons in 
the community with an emphasis on degenerative spine and will does some basic deformity.  Dr. Roybal uses a 
mini-open approach for his TLIF insertion, and a specialized retractor for visualization.  Dr. Roybal has taught 
many US courses and is recognized in the Savannah community as one of the top local physicians. 
3.8 Subject Eligibility Criteria: 
The principal investigator at each site is responsible for verifying that study subjects meet all inclusion/exclusion 
criteria.   
3.9 Inclusion Criteria:  
Subjects must meet all of the inclusion criteria to be included in this study.  
To be a part of this study, the subject must: 
1. Have been at least 18 years of age and skeletally mature at the time of surgery 
2. Have had clinical and radiological evidence of degenerative disc disease of the lumbar spine 

Protocol date July 18, 2019 
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3. Have been treated with PLIF or TLIF surgery using the FlareHawk expandable interbody cage(s) at 1 or 2 
contiguous levels from L2 to S1 
4. Have been treated using the FlareHawk expandable interbody fusion cage, according to the approved labeling, 
between December 1, 2017, and May 31, 2018  
3.10 Exclusion criteria: 
Subjects must not meet any of the following exclusion criteria to be included in the study: 
1. Have a history of fusion surgery at the study level(s) prior to treatment with the FlareHawk device(s) 
2. Have had spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure  
3. Have had surgery with the FlareHawk device(s) at more than 2 levels 
4. Have had surgery with the FlareHawk device(s) at levels outside the range of L2 to S1  
5. Have been treated with any bone grafting material other than autogenous or allogenic bone graft in the 
FlareHawk device(s) and surrounding disc space 
6. Have any contraindications listed in the approved labeling  
4.  Study Procedure 
4.1 Subject Chart Review: 
The chart reviews will be conducted by the study investigator or a trained study coordinator at each site. Records 
from all patients who underwent PLIF or TLIF surgery with the FlareHawk expandable cage between December 1, 
2017, and May 31, 2018, will be identified for further screening according the inclusion and exclusion criteria. Those 
subjects meeting all of the inclusion criteria and none of the exclusion criteria will be included for data collection. If 
there are not at least 118 patients included for data collection, the date range will be extended. If there are not at 
least 100 patients included with follow-up data at 12 (+/- 3) months, the date range will be extended.  
4.2 Data Collection Procedure: 
All data will be collected on de-identified case report forms (CRF) located at the participating site. Each subject will 
be identified only by a number which is generated at each site. No PHI will be available or seen by any study 
personnel with the exception of the investigator or his designee. All printed study records at the site will be 
maintained in a secure location. The data will be maintained by the investigator and information collected will be 
available to the study sponsor. 
Source Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a clinical trial 
necessary for the reconstruction and evaluation of the trial.  Source data are contained in source documents.  

Protocol date July 18, 2019 
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Page 11 
 
Examples of these original documents, and data records include: hospital records, clinical and office charts, 
laboratory notes, subjects’ diaries or evaluation checklists, copies or transcriptions certified after verification as 
being accurate and complete, and X-rays.  
Case Report Forms 
The study case report form (CRF) is the primary data collection instrument for the study.  All data requested on the 
CRF must be recorded.  All missing data must be explained.  If a space on the CRF is left blank because the 
procedure was not done or the question was not asked, write “N/D”.  If the item is not applicable to the individual 
case, write “N/A”.  All entries should be printed legibly in black ink.  If any entry error has been made, to correct 
such an error, draw a single straight line through the incorrect entry and enter the correct data above it.  All such 
changes must be initialed and dated.  DO NOT ERASE OR WHITE OUT ERRORS.  For clarification of illegible or 
uncertain entries, print the clarification above the item, then initial and date it. The investigator will be responsible 
for maintaining adequate, accurate CRFs to guarantee the proper interpretation of the data. 
4.3 Data to be Collected: 
After confirming inclusion in the study based on the above inclusion and exclusion criteria, data collection from the 
subject record will include the following, as available: 
1. Demographics: 
• Age 
• Gender at birth 
• Diagnosis 
• BMI 
• Co-morbid conditions 
o Hypertension 
o Diabetes 
o Obesity (BMI ≥ 30) 
o Hypercholesterolemia 
o Coronary Heart Disease 
o Hypothyroidism 
o Active or history of cancer 
o Other 
• Smoking Status 
 
 

Protocol date July 18, 2019 
V1 
Page 12 
 
2. Operative data: 
• Date of Surgery 
• Surgical level(s) 
• Description of all implants and graft materials used, including supplemental fixation if described 
• PLIF or TLIF approach 
• Open, mini-open, or minimally invasive procedure 
• Estimated blood loss 
• Length of surgery 
• Fluoroscopic exposure time 
• Intraoperative device- or procedure-related adverse events 
o Device component breakage/fracture 
o Device malfunction 
o Dural tear/injury 
o Nerve root injury 
o Device-related delay of surgery 
o Retained foreign body 
o Other 
• Length of hospitalization 
3. Patient reported outcomes surveys at preoperative baseline and each follow-up: 
• Visual Analog Scale (VAS) back and/or leg – Self Administered Questionnaire 
• Oswestry Disability Index (ODI) - Self Administered Questionnaire 
4. Radiographs:  
• Intraoperative post-implantation Lateral and AP X-rays of the lumbar spine 
• 12 months (+/- 3 months) follow-up Lateral, AP, and Flexion-Extension X-rays of the lumbar spine 
5. Post-operative device- or procedure-related adverse events 
• Infection 
• Donor site pain 
• Complex Regional Pain Syndrome 
• Urinary retention/difficulty 
• Ipsilateral or Contralateral radiculopathy 
• Device component fracture 

Protocol date July 18, 2019 
V1 
Page 13 
 
• Device or device component migration/retropulsion 
• Device complication (e.g. loss of expansion) 
• Device subsidence 
• Loss of fixation 
• Non-union 
• Vertebral fracture 
• Adjacent segment disease 
• Other 
4.4 Data Management Plan: 
Data processing and management will be carried out in accordance with the study-specific data processing plan. 
The data will be verified per the Monitoring Plan and CRFs will be collected by the clinical research associate (CRA) 
upon completion. Data will be entered into a password protected and encrypted database by the CRA and will be 
verified by double data entry.  
Any missing, implausible or inconsistent recordings will be referred back to the Investigator using a data query form 
and will be documented for each individual subject. Responses from the Investigator will be reviewed and updated 
in the Database. This process will be repeated until no further discrepancies are found. The data will be then be 
declared as clean. 
4.5 Monitoring Plan: 
This study will be monitored according to the monitoring plan.  The investigator and study staff will allocate 
adequate time for such monitoring activities.  The investigator will also ensure that the monitor or other compliance 
or quality assurance reviewer is given access to all the above noted study-related documents. A remote pre-
qualification assessment will be completed with the investigator and study staff to ensure they are experienced and 
available to conduct the study. Selected sites will participate in an initiation visit and will be trained on the study 
protocol and study related responsibilities. Interim remote or onsite monitoring visits will be conducted for cause and 
one on-site visit will occur once the study site has completed the CRFs, so that the CRA can verify the collected 
data to the source documents.  
5. Adverse Events: 
Per EN ISO 14155, an adverse event is defined as 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 as any undesirable deviation from the subject’s baseline condition 

Protocol date July 18, 2019 
V1 
Page 14 
 
to include all new conditions or symptoms, or worsening of the pre-existing condition or symptoms regardless of the 
cause.  This definition includes events related to the procedures involved.  
The intensity of the adverse event will be determined by the investigator using the following definitions established 
by the World Health Organization and not necessarily the subject’s interpretation: 
None:  patient outcome is not symptomatic, or no symptoms detected and no treatment is required.  
Mild: patient outcome is symptomatic, symptoms are mild, loss of function or harm is minimal or intermediate but 
short term, and no or minimal intervention (e.g., extra observation, investigation, review or minor treatment) is 
required.  
Moderate: patient outcome is symptomatic, requiring intervention (e.g., additional operative procedure; additional 
therapeutic treatment), an increased length of stay, or causing permanent or long-term harm or loss of function.  
Severe: patient outcome is symptomatic, requiring life-saving intervention or major surgical/medical intervention, 
shortening life expectancy or causing major permanent or long-term harm or loss of function  
Death: on balance of probabilities, death was caused or brought forward in the short term by the incident.  
The relationship of the AE to the implant or surgical procedure is determined according to the following definitions: 
Device related: The AE can be reasonably associated with the presence or performance of the device and follows 
a reasonable temporal sequence to the device implant 
Procedure related: The AE has been established as a potential risk or complication associated with any type of 
spinal surgical procedure and not specific to the receipt of the device. 
Not related: The AE has no temporal sequence from the receipt of the device or it can be explained by other 
factors, including underlying disease, concomitant medication or concurrent treatment. This also includes events 
associated with general surgical procedures (e.g. anesthesia reactions). 
5.1 Subject Safety: 
The expandable cage used in this study is currently used in standard of care procedures for these lumbar spine 
disorders. No experimental devices or products were used in this study and all patients were treated according to 
the standard practices of the study investigators.  
5.2 Mitigation of Risks: 
This is a retrospective chart review that does not introduce any additional risks to the patient. 
 
 

Protocol date July 18, 2019 
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Page 15 
 
6. Image and Data Analysis 
6.1 Radiographic Fusion Assessment: 
Radiographs will be evaluated by up to three reviewers (two primary reviewers and an adjudicator, as necessary, to 
evaluate any contradicting reviews by the primary reviewers).  Reviewers will be 3rd party board-certified orthopedic 
surgeons, neurosurgeons, or radiologists. 
Fusion status will be determined according to the Bridwell-Lenke grading system [Bridwell and Lenke et al, 1995], 
with grades 1-2 accepted as “Fused” and grades 3-4 accepted as “Not Fused”: 
• Grade 1: Fused with remodeling and trabeculae present 
• Grade 2: Graft intact, not fully remodeled and incorporated, but no lucency present  
• Grade 3: Graft intact, potential lucency present at top and bottom of graft 
• Grade 4: Fusion absent with collapse/resorption of the graft 
6.2 Data Analysis: 
Primary outcome:  
The proportion of levels achieving arthrodesis at 12 months (+/- 3 months) will be summarized as a percentage and 
95% confidence interval, based on the Wilson score method for binomial confidence intervals.  
Secondary outcomes:  
Continuous variables, such as baseline demographics and change in patient-reported outcomes from preoperative 
baseline to 12 months, will be summarized using mean, standard deviation, minimum and maximum values. Paired 
t-test or a non-parametric equivalent (if data does not satisfy assumptions of normality) will be used to determine if 
changes in VAS or ODI scores are statistically significant from preoperative baseline to 12 months (+/- 3 months) 
follow-up. Responder analyses for changes in patient-reported outcomes at 12 months (+/- 3 months) will be 
conducted using minimum clinically important differences (MCID). Significant clinical improvements from 
preoperative baseline to 12 months (+/- 3 months) follow-up will be determined on a per-patient basis using the 
following MCID values: 
• Improvement in ODI ≥ 10 points [Ostelo et al. 2008] 
• Improvement in VAS leg pain ≥ 15 points [Ostelo et al. 2008] 
• Improvement in VAS back pain ≥ 15 points [Ostelo et al. 2008] 
The proportion of patients with improvements exceeding the MCID values will be summarized as a percentage and 
95% confidence interval. 

Protocol date July 18, 2019 
V1 
Page 16 
 
Sub-group analyses will be performed based on the implant version (split-shim vs. “Version B”), history of previous 
surgery at the index level, patient co-morbidities, and demographic variables. 
For any adverse events, the observed rate of each type of event will be summarized as a percentage with the 95% 
confidence interval and compared with rates observed in the literature describing the current state of the art with 
other PLIF and TLIF interbody cages. 
7.  Ethical and Regulatory Requirements: 
7.1 Code of Conduct 
The Investigator will ensure that the clinical study is conducted in accordance with good clinical practice (GCP), EN 
ISO 41455, and all regulatory and institutional requirements, including those for subject privacy, informed consent, 
Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approval and record retention, and the Food 
and Drug Administration (FDA) Guidelines for the conduct of clinical trials. As this study is a retrospective chart 
review adding no additional risk to the subjects, a waiver of informed consent will be requested from the IEC/IRB. 
7.2 Subject Confidentiality 
The Sponsor will maintain the confidentiality of the identity of all subjects enrolled in the study and the information 
contained in their records.  The Sponsor will also instruct the study investigators in the importance of maintaining 
the confidentiality of study records.  The subject records will be made available as required for review by governing 
regulatory agencies and a reviewing IEC/IRB, however to every extent possible; the subject’s identities will not be 
disclosed. Compliance with EN ISO 14155 and the Health Insurance Portability and Accountability Act of 1996 
(HIPAA) is required and data collection must comply with the Standards for Privacy of Individually Identifiable 
Health Information, 45 CFR Part 160 and Part 164, as amended from time to time (the “Privacy Rule”), under 
HIPAA. 
The case report forms do not include any subject identifying information in accordance with HIPAA.  Therefore, 
once the data is entered on the CRF, a subject can no longer be identified.  It is the responsibility of the investigator 
to maintain a list of subject identification and ID numbers. 
7.3 Retention of Records by the Investigator 
The investigators will retain records for a period of 2 years following the date of the study conclusion. 
8. References  
Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K: Anterior fresh frozen structural allografts in the thoracic 
and lumbar spine. Do they work if combined with posterior fusion and instrumentation in adult patients with kyphosis 
or anterior column defects? Spine (Phila Pa 1976) 20:1410–1418, 1995. 

Protocol date July 18, 2019 
V1 
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Noshchenko A, Hoffecker L, Lindley EM, Burger EL, Cain CM, Patel VV. Long-term Treatment Effects of Lumbar 
Arthrodeses in Degenerative Disk Disease: A Systematic Review With Meta-Analysis. J Spinal Disord Tech. 
2015;28(9):E493-521. 
Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and functional status in low back pain: 
towards international consensus regarding minimal important change. Spine. 2008;33(1):90-4. 
Yavin D, Casha S, Wiebe S, et al. Lumbar Fusion for Degenerative Disease: A Systematic Review and Meta-
Analysis. Neurosurgery. 2017; 80(5):701-715. 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Investigator Approval 
Page 1 of 1 
 
Case Report Form: Investigator Approval 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
 
 
STUDY TITLE:   
  
  
 
Transforaminal/Posterior Lumbar Interbody Fusion with 
the FlareHawk® Expandable Interbody Fusion Device: 
  
  
  
A Retrospective Chart Review Study 
   
PROTOCOL DATE:  
July 18, 2019  
 
   
CLINICAL SITE NUMBER: 
 
SUBJECT NUMBER:  
 
 
 
  
 
 
 
PRINCIPAL INVESTIGATOR:  
 
 
(Printed Name) 
 
 
 
I am confident that the information supplied in this case report form is complete and 
accurate data. I confirm that the study was conducted in accordance with the protocol 
and any protocol amendments and that a waiver for informed consent has been 
approved by the IRB. 
   
  
Investigator Signature:  
 
 
Date: 
  
 
Case Report Forms Completed By: 
Signature: 
 
Date: 
Printed Name: 
 
  
 
NA, the Case Report Forms were completed by the Principal Investigator       
 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Inclusion/Exclusion Criteria 
Page 1 of 1 
 
Case Report Form: Inclusion/Exclusion Criteria 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
ALL patients treated with FlareHawk Interbody Fusion Device prior to September 30, 
2018 (9/30/2018) will be evaluated with the Inclusion/Exclusion criteria below. However, 
the remaining CRF data should only be collected for those patients meeting the criteria. 
INCLUSION CRITERIA 
1. Was the subject at least 18 years of age and skeletally mature at the time of 
surgery? 
 Yes 
 No 
2. Has the subject been diagnosed with degenerative disc disease of the lumbar 
spine based on clinical and radiological evidence? 
 Yes 
 No 
3. Has the subject been treated with PLIF or TLIF surgery using the FlareHawk 
expandable cage(s) at 1 or 2 contiguous levels from L2-S1? 
 Yes 
 No 
4. Has the subject undergone surgery using the FlareHawk expandable interbody 
fusion cage, according to approved labeling, prior to September 30, 2018? 
 Yes 
 No 
All inclusion criteria must be answered "Yes" to proceed to completing the remaining fields.  If 
any inclusion criteria were answered "No" do not collect additional data. 
 
 
  
EXCLUSION CRITERIA 
1. Does the subject have a history of fusion surgery at the study level(s) prior to 
treatment with the FlareHawk device(s)? 
 Yes 
 No 
2. Did the subject have spondylolisthesis unable to be reduced to grade 1 as part 
of the surgical procedure? 
 Yes 
 No 
3. Has the subject had surgery with the FlareHawk device(s) at more than 2 
levels? 
 Yes 
 No 
4. Has the subject had surgery with the FlareHawk device(s) at levels outside the 
range of L2- S1? 
 Yes 
 No 
5. Has the subject been treated with any bone grafting material other than 
autogenous or allogenic bone graft in the FlareHawk device(s) and surrounding 
disc space? 
 Yes 
 No 
6. Did the subject have any contraindications listed in the approved labeling? 
 Yes 
 No 
All exclusion criteria must be answered "No" to proceed to completing the remaining fields. If any 
exclusion criteria were answered "Yes" do not collect additional data 
 
 
  
ELIGIBILITY 
Did the Subject meet the Eligibility Criteria? 
 Yes 
 No 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Baseline Data – Visit 1 
Page 1 of 3 
 
Case Report Form: Baseline Data 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
VISIT 1 – BASELINE 
DATE OF VISIT: // 
 
      MM               DD                     YYYY 
DEMOGRAPHIC DATA 
Date of Birth: // Gender at Birth: 
 
Female  
Male 
 
 
 
 
 
MM               DD                      YYYY 
 
Height: 
  in. 
Weight:  
  lb. 
 
SMOKING STATUS 
Non-smoker    
Active smoker    
History of smoking    
Not Recorded    
 
COMORBID CONDITIONS 
Hypertension    
 
Diabetes    
 
Obesity (BMI ≥ 30)     
Hypercholesterolemia     
Coronary Heart Disease     
Hyperthyroidism    
 
Active Cancer 
 
History of Cancer    
 
 
 
If checked,  
type of cancer: ___________ 
If checked,  
type of cancer:  ___________ 
 
 
 
None recorded 
 
 
 
 
VISUAL ANALOG SCALE (VAS) 
 
Please enter the VAS score as documented at the baseline visit in the medical records for the level of 
RIGHT LEG pain.  
 
VAS Right Leg Pain Score:  
 
___________ 
 
Not Recorded    
 
 
Please enter the VAS score as documented at the baseline visit in the medical records for the level of 
LEFT LEG pain.  
 
VAS Left Leg Pain Score:  
 
___________ 
 
Not Recorded    
 
 
Please enter the VAS score as documented at the baseline visit in the medical records for the level of 
BACK pain. 
 
VAS Back Pain Score:  
___________ 
Not Recorded    

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Baseline Data – Visit 1 
Page 2 of 3 
 
Case Report Form: Baseline Data 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
OSWESTRY DISABILITY INDEX (ODI)  
 
Please transcribe answers directly from the patient’s medical record.  
(Circle score for each section recorded) 
 
 
Not Recorded    
 
Section 1 – Pain Intensity 
0 
I have no pain at the moment 
1 
The pain is very mild at the moment 
2 
The pain is moderate at the moment 
3 
The pain is fairly severe at the moment 
4 
The pain is very severe at the moment 
5 
The pain is the worst imaginable at the moment 
 
Section 2 – Personal Care (washing, dressing, etc.) 
0 
I have no pain at the moment 
1 
The pain is very mild at the moment 
2 
The pain is moderate at the moment 
3 
The pain is fairly severe at the moment 
4 
The pain is very severe at the moment 
5 
The pain is the worst imaginable at the moment 
 
Section 3 – Lifting  
0 
I can lift heavy weights without extra pain 
1 
I can lift heavy weights but it gives extra pain 
2 
Pain prevents me from lifting heavy weights off the 
floor, but I manage if they are conveniently placed 
e.g. on a table 
3 
Pain prevents me lifting heavy weights, but I can 
manage light to medium weights if they are 
conveniently positioned 
4 
I can lift very light weights 
5 
I cannot lift or carry anything at all 
 
 
 
 
Section 4 – Walking  
0 
Pain does not prevent me walking any distance 
1 
Pain prevents me from walking more than 1 mile 
2 
Pain prevents me from walking more than ½ mile 
3 
Pain prevents me from walking more than 100 
yards 
4 
I can only walk using a cane or crutches 
5 
I am in bed most of the time 
 
Section 5 – Sitting  
0 
I can sit in any chair as long as I like 
1 
I can only sit in my favorite chair as long as I like 
2 
Pain prevents me from sitting more than one hour 
3 
Pain prevents me from sitting more than 30 
minutes 
4 
Pain prevents me from sitting more than 10 
minutes 
5 
Pain prevents me from sitting at all 
 
Section 6 – Standing  
0 
I can stand as long as I want without extra pain 
1 
I can stand as long as I want but it gives me extra 
pain 
2 
Pain prevents me from standing more than 1 hour 
3 
Pain prevents me from standing more than 30 
minutes 
4 
Pain prevents me from standing for more than 10 
minutes 
5 
Pain prevents me from standing at all 
 
 
 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Baseline Data – Visit 1 
Page 3 of 3 
 
Case Report Form: Baseline Data 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
OSWESTRY DISABILITY INDEX (ODI) Continued 
 
Please transcribe answers directly from the patient’s medical record.  
(Circle score for each section recorded) 
 
 
Not Recorded    
 
Section 7 – Sleeping 
0 
My sleep is never disturbed by pain 
1 
My sleep is occasionally disturbed by pain 
2 
Because of pain I have less than 6 hours sleep 
3 
Because of pain I have less than 4 hours sleep 
4 
Because of pain I have less than 2 hours sleep 
5 
Pain prevents me from sleeping at all 
 
Section 8 – Sex Life (if applicable) 
0 
My sex life is normal and causes no extra pain 
1 
My sex life is normal but causes some extra pain 
2 
My sex life is nearly normal but is very painful 
3 
My sex life is severely restricted by pain 
4 
My sex life is nearly absent because of pain 
5 
Pain prevents any sex life at all 
 
 
Section 9 – Social Life  
0 
My social life is normal and gives me no extra pain 
1 
My social life is normal but increases the degree of 
pain 
2 
Pain has no significant effect on my social life 
apart from limiting my more energetic interests e.g. 
sports 
3 
Pain has restricted my social life and I do not go 
out as often 
4 
Pain has restricted my social life to my home 
5 
I have no social life because of pain 
 
Section 10 – Traveling  
0 
I can travel anywhere without pain 
1 
I can travel anywhere but it gives me extra pain 
2 
Pain is bad but I manage journeys over two hours 
3 
Pain restricts me to journeys of less than one hour 
4 
Pain restricts me to short necessary journeys 
under 30 minutes 
5 
Pain prevents me from traveling except to receive 
treatment 
 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Surgery – Visit 2 
Page 1 of 3 
 
Case Report Form: Surgery 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
VISIT 2 – SURGERY 
DATE OF SURGERY: // 
 
      MM               DD                     YYYY 
 
Total Operative Time: 
(Open to Close) 
 min. 
Estimated Blood 
Loss: 
 
cc./
ml.  
Length of 
Hospitalization: 
 days 
Fluoroscopic 
Exposure Time:  min. 
 
 
  
TYPE OF PROCEDURE 
Operative Procedure: 
Open    
Mini-open     
Minimally Invasive   
Operative Approach: 
PLIF     
TLIF    
 
 
 
Number of Levels: 
One     
Two    
 
 
 
Surgery Levels: 
L2-L3    
L3-L4    
 
L4-L5   
L5-S1  
 
 
IMPLANT(S) USED 
Implant #1 
Shell Catalog #   _______________________ 
Shim Catalog # 
_______________________ 
Shell Lot # 
_______________________ 
Shim Lot # 
_______________________ 
Implant #2 
NA  
Shell Catalog #   _______________________ 
Shim Catalog # 
_______________________ 
Shell Lot # 
_______________________ 
Shim Lot # 
_______________________ 
Implant #3 
NA  
Shell Catalog #   _______________________ 
Shim Catalog # 
_______________________ 
Shell Lot # 
_______________________ 
Shim Lot # 
_______________________ 
Implant #4 
NA  
Shell Catalog #   _______________________ 
Shim Catalog # 
_______________________ 
Shell Lot # 
_______________________ 
Shim Lot # 
_______________________ 
 
 
GRAFT MATERIAL 
 
Graft Materials Used: 
Allograft  
Autograft  
Mix of Allograft/Autograft  
 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Surgery – Visit 2 
Page 2 of 3 
 
Case Report Form: Surgery 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
SUPPLEMENTAL FIXATION 
Supplemental Fixation Used 
(check one): 
Unilateral  
Bilateral  
  
 
Description of 
Construct: 
 
________________________________________ 
 
________________________________________ 
 
 
 
 
ADVERSE EVENTS (AEs) 
 
Did any intra-operative adverse events occur? 
Yes  
No 
 
 
If “Yes”, add adverse event to Intra-Operative AE Log. 
 
 
DELAY OF SURGERY 
 
Device Related Delay of Surgery: 
 
Yes 
 
 
 
No 
 
 
If yes, how many 
minutes? 
 min. 
 
 
If yes, cause of 
delay? 
_____________________________________________________ 
 
_____________________________________________________ 
 
 
 
INSTRUMENTATION 
Were there any reported issues with instrument(s)? 
Yes  
No 
 
 
If yes, please provide the catalog and lot number below as well as the description of the issue with the 
instrument(s): 
 
Catalog # 
__________________ 
 
Description of issue: 
_____________________________ 
 
_____________________________ 
 
_____________________________ 
 
_____________________________ 
 
Lot # 
__________________ 
Not Recorded 
 
 
 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Surgery – Visit 2 
Page 3 of 3 
 
Case Report Form: Surgery 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
RADIOGRAPHS 
Are intra-operative, post-implantation X-rays available on CD? 
Yes  
No 
 
 
X-ray views taken (check those that apply): 
AP  
Lateral 
 
 
If X-rays are available, has the CD been provided to the 
evaluators? 
Yes  
No 
 
 
 
 
ADDITIONAL COMMENTS 
 
Please add any other pertinent information regarding the surgical procedure, the device/instruments 
or any safety concerns: 
 
 
 
_______________________________________________________________ 
 
_______________________________________________________________ 
 
_______________________________________________________________ 
 
_______________________________________________________________ 
 
 
 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Follow-up – Visit 3 
Page 1 of 3 
 
Case Report Form: Follow-up 
Integrity Implants, Inc. 
CP-00001 Attachment B  
Revision C 
Confidential 
 
VISIT 3 – 12 MONTHS (+/- 3MONTHS) 
DATE OF VISIT: // 
 
      MM               DD                     YYYY 
RADIOGRAPHS 
Are 12-month X-rays available on CD? 
Yes  
No 
 
 
X-ray views taken (check those that apply): 
AP 
 
Lateral  
Flexion/ 
Extension 
 
 
If X-rays are available, has the CD been provided to 
the evaluators? 
Yes  
No 
 
 
ADVERSE EVENTS (AEs) 
 
Did any post-operative adverse events occur? 
Yes  
No 
 
 
If “Yes”, add adverse event to Post-Operative AE Log. 
 
 
VISUAL ANALOG SCALE (VAS) 
 
Please enter the VAS score as documented at the follow-up visit in the medical records for the level of 
RIGHT LEG pain.  
 
VAS Right Leg Pain Score:  
 
___________ 
 
Not Recorded    
 
 
Please enter the VAS score as documented at the follow-up visit in the medical records for the level of 
LEFT LEG pain.  
 
VAS Left Leg Pain Score:  
 
___________ 
 
Not Recorded    
 
 
Please enter the VAS score as documented at the follow-up visit in the medical records for the level of 
BACK pain. 
 
VAS Back Pain Score:  
 
___________ 
 
Not Recorded    
 
 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Follow-up – Visit 3 
Page 2 of 3 
 
Case Report Form: Follow-up 
Integrity Implants, Inc. 
CP-00001 Attachment B  
Revision C 
Confidential 
 
OSWESTRY DISABILITY INDEX (ODI)  
 
Please transcribe answers directly from the patient’s medical record.  
(Circle score for each section recorded) 
 
 
Not Recorded    
 
Section 1 – Pain Intensity 
0 
I have no pain at the moment 
1 
The pain is very mild at the moment 
2 
The pain is moderate at the moment 
3 
The pain is fairly severe at the moment 
4 
The pain is very severe at the moment 
5 
The pain is the worst imaginable at the moment 
 
Section 2 – Personal Care (washing, dressing, etc.) 
0 
I have no pain at the moment 
1 
The pain is very mild at the moment 
2 
The pain is moderate at the moment 
3 
The pain is fairly severe at the moment 
4 
The pain is very severe at the moment 
5 
The pain is the worst imaginable at the moment 
 
Section 3 – Lifting  
0 
I can lift heavy weights without extra pain 
1 
I can lift heavy weights but it gives extra pain 
2 
Pain prevents me from lifting heavy weights off the 
floor, but I manage if they are conveniently placed 
e.g. on a table 
3 
Pain prevents me lifting heavy weights, but I can 
manage light to medium weights if they are 
conveniently positioned 
4 
I can lift very light weights 
5 
I cannot lift or carry anything at all 
 
 
 
 
Section 4 – Walking  
0 
Pain does not prevent me walking any distance 
1 
Pain prevents me from walking more than 1 mile 
2 
Pain prevents me from walking more than ½ mile 
3 
Pain prevents me from walking more than 100 
yards 
4 
I can only walk using a cane or crutches 
5 
I am in bed most of the time 
 
Section 5 – Sitting  
0 
I can sit in any chair as long as I like 
1 
I can only sit in my favorite chair as long as I like 
2 
Pain prevents me from sitting more than one hour 
3 
Pain prevents me from sitting more than 30 
minutes 
4 
Pain prevents me from sitting more than 10 
minutes 
5 
Pain prevents me from sitting at all 
 
Section 6 – Standing  
0 
I can stand as long as I want without extra pain 
1 
I can stand as long as I want but it gives me extra 
pain 
2 
Pain prevents me from standing more than 1 hour 
3 
Pain prevents me from standing more than 30 
minutes 
4 
Pain prevents me from standing for more than 10 
minutes 
5 
Pain prevents me from standing at all 
 
 
 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Follow-up – Visit 3 
Page 3 of 3 
 
Case Report Form: Follow-up 
Integrity Implants, Inc. 
CP-00001 Attachment B  
Revision C 
Confidential 
 
OSWESTRY DISABILITY INDEX (ODI) Continued 
 
Please transcribe answers directly from the patient’s medical record.  
 
 
Not Recorded    
 
Section 7 – Sleeping 
0 
My sleep is never disturbed by pain 
1 
My sleep is occasionally disturbed by pain 
2 
Because of pain I have less than 6 hours sleep 
3 
Because of pain I have less than 4 hours sleep 
4 
Because of pain I have less than 2 hours sleep 
5 
Pain prevents me from sleeping at all 
 
Section 8 – Sex Life (if applicable) 
0 
My sex life is normal and causes no extra pain 
1 
My sex life is normal but causes some extra pain 
2 
My sex life is nearly normal but is very painful 
3 
My sex life is severely restricted by pain 
4 
My sex life is nearly absent because of pain 
5 
Pain prevents any sex life at all 
 
 
Section 9 – Social Life  
0 
My social life is normal and gives me no extra pain 
1 
My social life is normal but increases the degree of 
pain 
2 
Pain has no significant effect on my social life 
apart from limiting my more energetic interests e.g. 
sports 
3 
Pain has restricted my social life and I do not go 
out as often 
4 
Pain has restricted my social life to my home 
5 
I have no social life because of pain 
 
Section 10 – Traveling  
0 
I can travel anywhere without pain 
1 
I can travel anywhere but it gives me extra pain 
2 
Pain is bad but I manage journeys over two hours 
3 
Pain restricts me to journeys of less than one hour 
4 
Pain restricts me to short necessary journeys 
under 30 minutes 
5 
Pain prevents me from traveling except to receive 
treatment 
 
 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Follow-up Visit – ODI Score 
Page 1 of 2 
 
Case Report Form: Follow-up ODI 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
FOLLOW-UP VISIT 
DATE OF VISIT: // 
 
      MM               DD                     YYYY 
OSWESTRY DISABILITY INDEX (ODI)  
 
Please transcribe answers directly from the patient’s medical record.  
(Circle score for each section recorded) 
 
 
Not Recorded    
 
Section 1 – Pain Intensity 
0 
I have no pain at the moment 
1 
The pain is very mild at the moment 
2 
The pain is moderate at the moment 
3 
The pain is fairly severe at the moment 
4 
The pain is very severe at the moment 
5 
The pain is the worst imaginable at the moment 
 
Section 2 – Personal Care (washing, dressing, etc.) 
0 
I have no pain at the moment 
1 
The pain is very mild at the moment 
2 
The pain is moderate at the moment 
3 
The pain is fairly severe at the moment 
4 
The pain is very severe at the moment 
5 
The pain is the worst imaginable at the moment 
 
Section 3 – Lifting  
0 
I can lift heavy weights without extra pain 
1 
I can lift heavy weights but it gives extra pain 
2 
Pain prevents me from lifting heavy weights off the 
floor, but I manage if they are conveniently placed 
e.g. on a table 
3 
Pain prevents me lifting heavy weights, but I can 
manage light to medium weights if they are 
conveniently positioned 
4 
I can lift very light weights 
5 
I cannot lift or carry anything at all 
 
 
 
 
Section 4 – Walking  
0 
Pain does not prevent me walking any distance 
1 
Pain prevents me from walking more than 1 mile 
2 
Pain prevents me from walking more than ½ mile 
3 
Pain prevents me from walking more than 100 
yards 
4 
I can only walk using a cane or crutches 
5 
I am in bed most of the time 
 
Section 5 – Sitting  
0 
I can sit in any chair as long as I like 
1 
I can only sit in my favorite chair as long as I like 
2 
Pain prevents me from sitting more than one hour 
3 
Pain prevents me from sitting more than 30 
minutes 
4 
Pain prevents me from sitting more than 10 
minutes 
5 
Pain prevents me from sitting at all 
 
Section 6 – Standing  
0 
I can stand as long as I want without extra pain 
1 
I can stand as long as I want but it gives me extra 
pain 
2 
Pain prevents me from standing more than 1 hour 
3 
Pain prevents me from standing more than 30 
minutes 
4 
Pain prevents me from standing for more than 10 
minutes 
5 
Pain prevents me from standing at all 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Follow-up Visit – ODI Score 
Page 2 of 2 
 
Case Report Form: Follow-up ODI 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
OSWESTRY DISABILITY INDEX (ODI) Continued 
 
Please transcribe answers directly from the patient’s medical record.  
(Circle score for each section recorded) 
 
 
Not Recorded    
 
Section 7 – Sleeping 
0 
My sleep is never disturbed by pain 
1 
My sleep is occasionally disturbed by pain 
2 
Because of pain I have less than 6 hours sleep 
3 
Because of pain I have less than 4 hours sleep 
4 
Because of pain I have less than 2 hours sleep 
5 
Pain prevents me from sleeping at all 
 
Section 8 – Sex Life (if applicable) 
0 
My sex life is normal and causes no extra pain 
1 
My sex life is normal but causes some extra pain 
2 
My sex life is nearly normal but is very painful 
3 
My sex life is severely restricted by pain 
4 
My sex life is nearly absent because of pain 
5 
Pain prevents any sex life at all 
 
 
Section 9 – Social Life  
0 
My social life is normal and gives me no extra pain 
1 
My social life is normal but increases the degree of 
pain 
2 
Pain has no significant effect on my social life 
apart from limiting my more energetic interests e.g. 
sports 
3 
Pain has restricted my social life and I do not go 
out as often 
4 
Pain has restricted my social life to my home 
5 
I have no social life because of pain 
 
Section 10 – Traveling  
0 
I can travel anywhere without pain 
1 
I can travel anywhere but it gives me extra pain 
2 
Pain is bad but I manage journeys over two hours 
3 
Pain restricts me to journeys of less than one hour 
4 
Pain restricts me to short necessary journeys 
under 30 minutes 
5 
Pain prevents me from traveling except to receive 
treatment 
 
 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Follow-up Visit – VAS Score 
Page 1 of 1 
 
Case Report Form: Follow-up VAS 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
FOLLOW-UP VISIT 
DATE OF VISIT: // 
 
      MM               DD                     YYYY 
VISUAL ANALOG SCALE (VAS) 
 
Please enter the VAS score as documented at the follow-up visit in the medical records for the level of 
RIGHT LEG pain.  
 
VAS Right Leg Pain Score:  
 
___________ 
 
Not Recorded    
 
 
Please enter the VAS score as documented at the follow-up visit in the medical records for the level of 
LEFT LEG pain.  
 
VAS Left Leg Pain Score:  
 
___________ 
 
Not Recorded    
 
 
Please enter the VAS score as documented at the follow-up visit in the medical records for the level of 
BACK pain. 
 
VAS Back Pain Score:  
 
___________ 
 
Not Recorded    
 
 

 
Clinical Site Number:             
Subject Number:  
 
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Intra-Operative Adverse Event Log 
Page 1 of 1 
 
Case Report Form: Intra-Op AE Log 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
Confidential 
 
INTRA-OPERATIVE ADVERSE EVENT (AE) LOG 
No AEs Recorded   
If Adverse Events have occurred, check “yes” or “no” for each event listed below. If “yes” is marked for an Adverse Event below, please complete all of the 
columns to the right. 
Adverse Events 
Yes / No 
Severity 
Relatedness 
Action Taken 
Outcomes 
1- None 
2- Mild 
3- Moderate 
4- Severe 
5- Death 
1- Device related 
2- Procedure related 
3- Not related 
1- None 
2- Medication/Therapy 
3- Revision Surgery 
4- Additional Surgery 
5- Other 
1- Resolved 
2- Ongoing at 12-month 
(+/- 3 month) Follow-
up 
3- Unknown 
Device component 
breakage/fracture  
Yes   
No   
 
 
 
 
Device malfunction 
Yes   
No   
 
 
 
 
Dural tear/injury 
Yes   
No   
 
 
 
 
Nerve root injury 
Yes   
No   
 
 
 
 
Other Adverse Events (Describe event below) 
Severity 
Relatedness 
Action Taken 
Outcomes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Clinical Site Number:             
Subject Number:  
 
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Post-Operative Adverse Event Log 
Page 1 of 2 
 
Case Report Form: Post-Op AE Log 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
POST-OPERATIVE ADVERSE EVENT (AE) LOG 
No AEs Recorded   
If Adverse Events have occurred, check “yes” or “no” for each event listed below. If “yes” is marked for an Adverse Event below, please complete all of the 
columns to the right. 
Adverse Events 
Yes / No 
Onset Date 
Resolution Date 
Severity 
Relatedness 
Action Taken 
Outcomes 
MM/DD/YYYY 
MM/DD/YYYY 
1- None 
2- Mild 
3- Moderate 
4- Severe 
5- Death 
1- Device 
related 
2- Procedure 
related 
3- Not related 
1- None 
2- Medication/
Therapy 
3- Revision 
Surgery 
4- Additional 
Surgery 
5- Other 
1- Resolved 
2- Ongoing at 
12-month (+/- 
3 month) 
Follow-up 
3- Unknown 
Infection 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Donor site pain 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Complex regional pain 
syndrome 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Urinary retention/difficulty 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Ipsilateral or contralateral 
radiculopathy 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Device component 
breakage/fracture 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Device or device component 
migration/retropulsion 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Device complication 
(e.g. loss of expansion) 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Device subsidence 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Loss of fixation 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Non-union 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Vertebral fracture 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
Adjacent segment disease 
Yes   
No   
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 

 
Clinical Site Number:             
Subject Number:  
 
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Post-Operative Adverse Event Log 
Page 2 of 2 
 
Case Report Form: Post-Op AE Log 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
POST-OPERATIVE ADVERSE EVENT (AE) LOG Continued 
No AEs Recorded    
Please complete all columns below if additional Adverse Events are recorded. 
Other Adverse Events 
(Describe event below) 
Onset Date 
Resolution Date 
Severity 
Relatedness 
Action Taken 
Outcomes 
MM/DD/YYYY 
MM/DD/YYYY 
1- None 
2- Mild 
3- Moderate 
4- Severe 
5- Death 
1- Device 
related 
2- Procedure 
related 
3- Not related 
1- None 
2- Medication/
Therapy 
3- Revision 
Surgery 
4- Additional 
Surgery 
5- Other 
1- Resolved 
2- Ongoing at 
12-month (+/- 
3 month) 
Follow-up 
3- Unknown 
 
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
 
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
 
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
 
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
 
_ _ /_ _ /_ _ _ _ 
_ _ /_ _ /_ _ _ _ 
 
 
 
 
 

 
Clinical Site Number:   Subject Number:   
Case Report Form 
 
Integrity Implants FlareHawk® Study 
Radiographic Reviewer 
Page 1 of 1 
 
Case Report Form: Radiographic Review 
Integrity Implants, Inc. 
CP-00001 Attachment B   
Revision C 
 
Confidential 
 
CRF TO BE COMPLETED BY RADIOGRAPHIC REVIEWER ONLY 
DATE OF X-RAY: // 
 
      MM               DD                     YYYY 
 
RADIOGRAPHS 
X-ray views evaluated (check all that apply): 
AP  
Lateral  
Flexion/Extension  
 
RADIOGRAPHS 
 
Using the Bridwell-Lenke grading system, what is the X-ray fusion 
status at L2 - L3? 
Grade 1 
 
Grade 2 
 
Grade 3 
 
 
Grade 4 
 
NA – Subject not implanted with FlareHawk device at L2-L3 
 
 
Using the Bridwell-Lenke grading system, what is the X-ray fusion 
status at L3 – L4? 
Grade 1 
 
Grade 2 
 
Grade 3 
 
 
Grade 4 
 
NA – Subject not implanted with FlareHawk device at L3-L4 
 
 
Using the Bridwell-Lenke grading system, what is the X-ray fusion 
status at L4 – L5? 
Grade 1 
 
Grade 2 
 
Grade 3 
 
 
Grade 4 
 
NA – Subject not implanted with FlareHawk device at L4-L5 
 
 
Using the Bridwell-Lenke grading system, what is the X-ray fusion 
status at L5- S1? 
Grade 1 
 
Grade 2 
 
Grade 3 
 
Grade 4 
 
NA – Subject not implanted with FlareHawk device at L5-S1 
 
 
Was any magnification adjustment used by the radiographic reviewer to grade fusion 
status? 
 Yes  No 
 
 
If “Yes”, describe below: 
_________________________________________________ 
 
 
APPROVAL 
 
Reviewer Signature:     _______________________ 
     
 
Date: ____________