Guidance for Industry and FDA Staff 
Clinical Data Presentations for 
Orthopedic Device Applications 
Document issued on: December 2, 2004  
For questions regarding this document contact Barbara Buch, M.D. at 240-276-3737 or 
by email at barbara.buch@fda.hhs.gov.   
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Orthopedic Devices Branch 
Division of General, Restorative, and Neurological Devices 
Office of Device Evaluation  Contains Nonbinding Recommendations 
Preface 
Public Comment 
Written comments and suggestions may be submitted at any time for Agency consideration to the 
Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
(HFA-305), Rockville, MD, 20852.  When submitting comments, please refer to the exact title of 
this guidance document.  Comments may not be acted upon by the Agency until the document is 
next revised or updated.   
Additional Copies 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/ode/guidance/1542.pdf, or to receive this document by fax, call the 
CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone.  Press 1 to enter the system.  At the second voice prompt, press 1 to order a document.  
Enter the document number (1542) followed by the pound sign (#).  Follow the remaining voice 
prompts to complete your request.    Contains Nonbinding Recommendations 
Table of Contents 
1. INTRODUCTION.............................................................................................................1
2. GENERAL DATA PRESENTATION: RECOMMENDED ELEMENTS.................2 
3. DESCRIPTION OF STUDY POPULATION................................................................5 
4. PATIENT ACCOUNTING..............................................................................................6 
5. SAFETY.............................................................................................................................7 
6. EFFECTIVENESS..........................................................................................................11
7. PATIENT SUCCESS RESULTS...................................................................................12 
8. ELEMENTS OF CLINICAL DATA PRESENTATIONS..........................................13  Contains Nonbinding Recommendations 
Guidance for Industry and FDA Staff 
Clinical Data Presentations for Orthopedic 
Device Applications 
This guidance document represents the Food and Drug Administration's (FDA's) current 
thinking on this topic.  It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public.  You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to discuss an 
alternative approach, contact the FDA staff responsible for implementing this guidance 
document.  If you cannot identify the appropriate FDA staff, call the appropriate number 
listed on the title page of this guidance document.  
1. Introduction
This guidance document is intended to provide you with recommended general clinical data 
presentation formats for premarket notifications (510(k)s), investigational device exemption (IDE) 
annual progress reports, premarket approval (PMA) applications, and annual and post-approval 
study reports for orthopedic implant devices.  FDA is issuing this document to help ensure 
consistency and understanding between FDA and sponsors when discussing and presenting 
clinical data. We hope this guidance will conserve FDA and industry resources and facilitate 
timely review. 
The data presentation formats described in this guidance document are intended to standardize 
presentations to facilitate review of Orthopedic Devices Branch (ORDB) submissions.  The 
descriptions and definitions used in this document are commonly used in ORDB but may not be 
applicable to submissions in other product areas. 
This guidance document is not intended to provide you with information regarding the 
presentation of preclinical data, nor is it intended to describe all elements required for 510(k)s, 
IDEs, or PMAs.  This guidance document supplements other FDA publications on 510(k), IDE, 
and PMA submissions and should not be construed as a replacement for these documents.   
Premarket Notification -510(k) Information 
For general information on 510(k), refer to 21 CFR 807.87 and How to Prepare a 510(k) 
Submission in CDRHs Device Advice at http://www.fda.gov/cdrh/devadvice/314.html. In 
addition, there may be other guidance documents specific to your type of device located on 
the FDA website, http://www.fda.gov/cdrh/guidance.html. 
Investigational Device Exemption Information 
For general IDE information, refer to 21 CFR Part 812 or to the Guidance on Investigational 
page 1  Contains Nonbinding Recommendations 
Device Exemptions Policies and Procedures, available at 
http://www.fda.gov/cdrh/devadvice/ide/inde.x  . shtml.
Investigational Device Exemption Report Information 
There are additional elements that are necessary for the completion of an IDE report and they 
are outlined in FDA's document titled, "Suggested Format for IDE Progress Report," 
available at http://www.fda.gov/cdrh/devadvice/ide/re. p orts.shtml.
Premarket Approval Application  (PMA) Information 
For general PMA information, refer to 21 CFR 814 or 
http://www.fda.gov/cdrh/devadvice/pma/app_methods.html.  In addition, there may be other 
guidance documents specific to your type of device located on the FDA website, 
http://www.fda.gov/cdrh/guidance.html. 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidance documents describe the Agency's current thinking on a topic 
and should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidance documents means that 
something is suggested or recommended, but not required. 
The Least Burdensome Approach 
The issues identified in this guidance document represent those that we believe should be 
addressed before your device can be marketed.  In developing the guidance, we carefully 
considered the relevant statutory criteria for Agency decision-making.  We also considered the 
burden that may be incurred in your attempt to follow the guidance and address the issues we 
have identified.  We believe that we have considered the least burdensome approach to resolving 
the issues presented in the guidance document.  If, however, you believe that there is a less 
burdensome way to address the issues, you should follow the procedures outlined in the A 
Suggested Approach to Resolving Least Burdensome Issues document.  It is available on our 
Center web page at https://www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/UCM588914.pdf. 
2.  General Data Presentation: Recommended Elements
For all data presentations, we recommend that you clearly identify the number of patients 
evaluated at a given timepoint in any data presentation, in addition to the rate of improvement, for 
example, 64/75 patients at 3 months rather than 85% at the 3 month timepoint.  For any table, 
a clear description of the population on which it is based is important.  In other words, if the 
result is 64/75, but the population was 100 patients, you should account for the remaining 25 
patients.   
We recommend that you consider the examples of formats for data presentation in this document 
when you are designing your study to better assure that you collect adequate data.  We 
recommend that you provide the information below, as appropriate to support a 510(k), IDE 
annual report, or PMA (including PMA annual and post approval study reports):  
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Description of the patient population 
This description includes a detailed discussion of the patient demographics in each treatment 
group (see also section 3. Description of Study Population).  We recommend that you 
include any important demographic factors that may influence outcomes.  This may include, 
but is not limited to:  
  age 
  gender 
  co-morbid conditions 
  work status 
  smoking history 
  diagnostic groups. 
 
Time course distribution of patient accounting  
This includes an accounting of the status of each patient at each follow-up interval (e.g., 
theoretical follow-up, deaths, reoperations, revisions, removals, supplemental fixations, 
expected follow-up, actual follow-up, and follow-up rate).  These are discussed in section 4. 
 Patient Accounting.  We recommend that you include a clear description of the evaluation 
intervals pre- and post-treatment.  We recommend that an appropriate follow-up window for 
the evaluation interval be pre-defined in the IDE protocol.  We recommend the windows 
around the intervals be distinct, as small as possible, and not continuous, for example:  
  6 weeks  2 weeks 
  3 months  2 weeks 
  6 months  1 month 
  12 months  2 months 
  24 months  2 months 
  annually  2 months.   
 
FDA believes that defining evaluation windows before initiating the study is optimal for 
comparing homogenous patients at each different follow-up timepoint in the postoperative 
period.   
 
Written (narrative) descriptions of adverse events 
Written (narrative) descriptions of adverse events should include both details of the events 
and demographic information (see Section 5. Safety). 
 
The details of the events should include: 
  any subsequent surgical interventions 
  deaths 
  protocol deviations  
  severe complications that occur, including any actions taken as a result  
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  resolutions.   
 
The demographic information should include:  
  device implanted 
  diagnosis 
  level or site of implantation 
  pertinent medical information. 
 
We also recommend that you include any other information related to any association 
between the device and the event described.   
 
After identifying these events, if you change your study protocol or surgical technique, we 
recommend that you describe the changes and explain how these changes avoid or reduce the 
occurrence of adverse events. 
 
Time course distributions of all adverse events for all patients receiving a treatment or 
implant 
We recommend that you present this distribution in a table (see Tables 3 and 4).  A separate 
table should be presented to describe any subsequent surgical interventions (see Table 5). 
 
Time course distributions of effectiveness parameters 
This distribution includes the following parameters: 
  pain  
  function  
  radiographic assessment of fusion  
  radiographic assessment of the implant 
  health related quality of life 
  return to work status 
  other evaluation parameters appropriate to your endpoints.   
 
These time course distributions should provide the number of patients who meet each success 
criterion for each parameter (e.g., as for pain, function) and should provide the number of 
patients evaluated within a given group for each parameter (see Table 6). 
 
Time course distributions of the individual patient success rates  
This distribution should include success rates for all patients over the course of the study (see 
section 7. Patient Success Results and Table 7).  This allows for an appraisal of the patients 
progress over time. 
 
For each of the data presentations above, we recommend that you stratify patients into the 
following subgroups, as appropriate for the particular study design: 
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  investigational and control groups 
  group being studied (e.g., bilateral joints, unilateral joints, single level fusion, two 
level fusion, non inflammatory, inflammatory arthritis) 
  separate subgroups, where appropriate, unless the study is masked 
  separate presentations for patients implanted outside of the study (e.g., compassionate 
use or continued access patients). 
 
We also recommend that you provide separate presentations for patients who do not follow 
the study protocol.  These patients may include those who did not meet all of the inclusion or 
exclusion criteria, did not receive all of the study implant components, or patients who are 
evaluated outside of the protocol-established time windows.  Therefore, we recommend that 
you provide clinical and statistical rationales for their inclusion and for pooling of these 
patients data.   
 
General Safety Event Reporting 
We recommend that you report all adverse events, regardless of rate of occurrence, as they 
occur throughout the study. 
 
We may recommend additional or more detailed data presentations for your application if 
describing specific subsets of clinical data or other information will further elucidate the 
clinical performance of your device. 
 
3.  Description of Study Population 
We recommend that you provide a complete description of the patient population.  This verifies 
that the groups being evaluated are similar and that the variances in the study groups are similar 
enough to compare the groups statistically and clinically.  We recommend that you list the 
demographics and all of the diagnoses and subgroups involved in the investigation, indicating 
the number of patients that have that diagnosis.  This list should incorporate any important 
patient characteristics that may influence patient outcomes, such as preoperative work status, 
education, and smoking status.  Depending on the inclusion and exclusion criteria, we 
recommend that you also include confounding factors such as the number of patients who abuse 
alcohol, are involved in workers compensation or medical litigation, race (if appropriate), 
medical co-morbidity, previous surgery, degree of medication use, and involvement of other 
adjacent or nonadjacent joints or spinal levels.  We also recommend that you include treatment 
demographics, such as operative times, blood loss, length of hospital stay, and post operative 
bracing, for each treatment group.  Table 1 is a sample table for presenting demographic 
information described above. 
 
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Table 1  Demographic Information 
  I  C  
Number of patients     
Men/women     
Mean age, year (range)     
Education level     <High School                       
                                
High School Diploma     
>High School.     
Smoking  Yes     
No     
Alcohol use  Yes     
No     
Preop Employment  Working     
Status  Not working     
Medical Conditions  Diabetes     
Cardiac, etc     
Diagnosis  Osteoarthritis     
(# of patients and #  Osteonecrosis     
of joints)  Rheumatoid arthritis     
Other     
I= investigational group; C = control group 
 
4.  Patient Accounting 
Table 2 below is a sample table for patient accounting.  Refer to section 8. Elements of Clinical 
Data Presentations for complete definitions of each of the elements included in that table.   
 
Table 2  Patient Accounting  
  Preop  6 wks  3 mo  6 mo  12 mo  24 mo  36 mo 
  I  C  I  C  I  C  I  C  I  C  I  C  I  C 
Theoretical                             
Deaths                             
(cumulative) 
Failures                             
(cumulative) 
Expected                             
ActualA                               
ActualB                             
% Follow-up                             
I = investigational group; C = control group 
APatients with complete data for each endpoint, evaluated per protocol, in the window time 
frame.  
BPatients with any follow-up data reviewed or evaluated by investigator (all evaluated 
accounting).  
 
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Where appropriate, an additional line for patients not yet overdue (see 8. Elements of Clinical 
Data Presentations) may be added to this table. 
 
As stated in section 8. Elements of Clinical Data Presentations, Actual includes those 
patients with complete assessment evaluations collected for each endpoint as per the protocol.  
However, we understand that not all studies operate under ideal conditions and, in some 
circumstances, not all patients are followed up at the intended time intervals or circumstances 
prevent collection of all data points to determine patient outcomes.  Therefore, it may be 
appropriate to provide a patient accounting table that also includes any patient who has been 
followed during the study regardless of whether data for all study end points has been collected.  
This is referred to as all evaluated accounting. 
 
For an IDE or PMA report or an original PMA, FDA recommends a minimum of 85% follow-up 
of patients in each study cohort to maintain the power of the study, avoid the potential for bias, 
and provide sufficient data for analysis.  If an IDE or PMA report does not show that the study is 
meeting this goal, we recommend that you provide an adequate explanation for not meeting this 
goal and describe what steps are being taken to achieve adequate patient follow-up. 
 
FDA may recommend that you perform a sensitivity analysis at the time of final data submission to 
assist in explaining, both clinically and statistically, the pooling of those patients with incomplete 
outcome data or out of window data with those patients who have complete data collected per the 
protocol. Your analysis should clearly define the number of patients evaluated within the time 
windows, before the time window, or after the time window for each evaluation interval.    
 
5.  Safety 
We recommend that you organize the safety outcomes into two general categories: adverse 
events and subsequent secondary surgical interventions.   
 
Adverse Events 
We recommend that you record and report all preoperative, operative, and postoperative 
complications, whether device-related or not.  These include anticipated and unanticipated 
complications.  Pain, neurological, and function symptoms are categorized as complications 
when a patients complaint for any of these symptoms results in an unscheduled visit or when 
a patient presents with new or worsening symptoms as compared to the previous visit.  We 
recommend that you categorize or group adverse events according to the World Health 
Organization recommendations1 or another accepted method of categorizing adverse events.  
We recommend that you make a determination of device-related, operative site-related, and 
systemic (non-device related) events, if possible.   
 
                                                 
1World Health Organization (WHO), International Classification Systems, 
http://www.who.int/classifications.  See also Chapter 5, Mental and Behavioural 
Disorders in The International Statistical Classification of Diseases.  WHO.  See also 
the Primary Care Version and Educational Kit in Related Health Problems, in 
International Classification of Impairments, Disability and Handicaps.  WHO. 
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Table 3 below illustrates one way of presenting adverse events for a total joint device, 
stratified by operative site and systemic events.  The time course of adverse events follows 
the same logic as the patient accounting table.  Each adverse event is identified by listing it 
vertically down the left column of the table.  Across the top row of the table are the 
scheduled follow-up visits.  The table should include the number of occurrences for each 
type of event and the number of patients evaluated at each time interval.   
 
Table 3  Adverse Events (Sample for Total Joint Device) 
  Immed.  3 mo  6 mo  12 mo  24 mo  36 mo 
Post-op 
  I  C  I  C  I  C  I  C  I  C  I  C 
  N=  N=  N=  N=  N=  N=  N= N=  N=  N=  N=  N= 
Operative Site Events 
Infection                                
Wound dehiscence                            
Dislocation                         
Fracture implant                          
liner, head etc. 
Fracture bone                         
Other                         
Systemic Events 
Myocardial infarction                         
Pulmonary emboli                         
Urinary tract infection                         
Other                         
N = number of patients evaluated at that time period.   
I = Investigational group; C = Control group 
 
Note: If patients experience more than one adverse event, we recommend that the narratives 
describe recurrent events. 
 
Table 4 below is another similar format for presenting a time course distribution of adverse event 
for a spinal implant system. 
 
page 8    Contains Nonbinding Recommendations 
 
Table 4  Adverse Events (Sample for Spinal System) 
Op  D/C- 6wks- 3-6 mo  6-12 mo  12-22 mo  22-26 mo  26-34 mo
  6wks  3mo 
I  C  I  C  I  C  I  C  I  C  I  C  I  C  I  C 
  N=  N=  N=  N=  N= N= N=  N= N= N= N= N=  N=  N=  N= N= 
Implant Related 
Implant 
displacement                                
/loosening 
Malpositione
                               
d implant 
Non-union                                  
Subsidence                                 
Infection                                 
Surgery Related 
Anatomic/ 
technical                                 
difficulty 
Dural injury                                 
Retrograde 
                               
ejaculation 
Back/leg pain                                 
Graft site                                 
Neurological                                 
Spinal event                                 
Vascular, 
                               
intraoperative 
Vertebral 
                               
fracture 
Systemic 
Urinary tract 
                               
infection 
Cardiac 
                               
events 
Etc.                                 
I = Investigational group; C = Control group 
N = number of patients evaluated at that time period.  
Note:  If patients experience more than one adverse event, we recommend that the narratives describe 
recurrent events. 
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Subsequent Secondary Surgical Interventions 
Some adverse events lead to a subsequent secondary surgical intervention.  We recommend 
that you report subsequent secondary surgical interventions, separately from the presentation 
of other adverse events.  The reporting of these events is performed in the same manner as 
deaths.  For example, a patient was revised at or prior to the immediate post-op examination.  
We suggest that you report this revision under the immediate post-op follow-up visit.  If, at 
some time between their immediate post-op examinations and their individually scheduled 3-
month follow-ups, 2 additional patients had revisions, then you should report these 2 
revisions at the 3-month follow-up timepoint because the examinations took place between 
the immediate post-op examination and the 3-month follow-up.   
 
FDA categorizes subsequent surgical interventions as follows: 
  revisions 
  removals 
  reoperations 
  supplemental fixations 
  other interventions. 
 
Refer to Section 8. Elements of Clinical Data Presentations for complete definitions of each of 
above categories of subsequent surgical interventions. 
 
We recommend that you incorporate the definitions for subsequent secondary surgical 
interventions listed above into an IDE protocol, to assure consistency in reporting outcomes.   
 
We recommend that you capture the reason for each subsequent secondary surgical intervention 
and the action taken (e.g., replacement of a screw, placement of extra bone grafting material, 
revision of a hip stem).  Along with the presentation of the subsequent secondary surgical 
interventions pooled into the five categories above, we recommend that each category be further 
stratified.  For example, the revision category may be stratified into separate categories such as 
revision for translated cage, removal of screws, depending on the reasons identified in a 
particular study.  As another example, the removal category may be stratified into removal for 
pain at the operative site after fusion or pseudoarthrosis, etc. 
 
FDA believes that some reasons for performing a removal may constitute a failure; however, this 
is also dependent on the device type.  We recommend that you clearly identify which reasons for 
removal constitute a patient failure and provide a rationale.  For example, removal of a cage at 
any time should constitute a failure, however, removal of a pedicle screw system after fusion 
may not.  If removal surgery is recommended in the protocol for a given implant, we recommend 
that you clearly indicate in your IDE protocol how such removals will be interpreted in terms of 
success and failure of the study.  Additionally, we recommend that you identify any other 
subsequent surgical intervention that constitutes a patient failure. 
 
Table 5 below illustrates one way of presenting subsequent surgical interventions.  You should 
indicate the number of patients who underwent the specific intervention at each timepoint.  If the 
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number of implants differs from the number of patients, we recommend that you provide 
explanatory descriptions in the adverse event narratives. 
 
Table 5  Subsequent Secondary Surgical Interventions 
Type  Op  D/C  6 wk  3 mo 6 mo  12 mo 24 mo  Total  # 
events  patients 
I  C  I  C  I C  I  C I  C  I  C I  C  I  C  I  C 
Revisions                                     
Removals                                     
Supplemental                                     
Fixations 
Reoperations                                     
OtherA                                     
Total                                     
I = investigational group; C = control group 
AThe other types of surgical interventions should be defined.  
 
Any events occurring after 24 months may be placed in an additional column headed more than 
24 months. 
 
6.  Effectiveness  
The effectiveness clinical summary submitted in support of a PMA should be more detailed than 
that of an annual report.   
 
When an evaluation method such as a Harris Hip Score is used, we recommend that patient 
results be presented as the number of implants with each rating score.   
 
We recommend that you summarize your results in tabular form and include each stratified 
group being studied (e.g., bilateral joints, unilateral joints, single level fusion, two level fusions, 
non inflammatory arthritis, inflammatory arthritis).  We recommend that you provide a separate 
table for patients implanted outside of the study (e.g., compassionate use or continued access 
patients).  See the example in Table 6. 
 
Table 6 presents a typical orthopedic clinical evaluation system (Harris Hip Score).  The number 
of patients and procedures that meet each rating is listed under the Total Score, Pain Score, and 
Function sections.  Similar tables can be used for other endpoint assessments. 
 
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Table 6  General Effectiveness Data Summary Table 
  Immed.  3 mo  6 mo  12 mo  24 mo  24+ mo 
Post-op 
  I  C  I  C  I  C  I  C  I  C  I  C 
  N=  N=  N=  N=  N=  N=  N=  N=  N=  N=  N=  N= 
Total Score Rating 
Excellent (91-100)                         
Good (81-90)                         
Fair (71-80)                         
Poor (<71)                         
Pain Score 
None (40-45)                         
Mild (30-39)                         
Moderate (20-29)                         
Severe (10-19)                         
Disabled (0-9)                         
Function Score 
Normal (40-45)                         
Mild Disfunction                         
(30-39) 
Mod. Disfunction                         
(20-29) 
Severe (10-19)                         
Disabled (0-9)                         
I = Investigational group; C = Control group; N = Number of implants and patients evaluated at 
that time period.  If the number of implants and patients evaluated differs from the overall N in 
any specific category, the number of implants and patients evaluated in that category should be 
provided in the denominator for each parameter. 
 
7.  Patient Success Results 
We recommend that you provide a summary table of the patient success results.  For each 
parameter evaluated, we recommend that you provide the number of patients who have met the 
success criterion for each timepoint.  Within each entry, we recommend that you provide the 
number of patients evaluated.  If appropriate, you should also provide a separate row designating 
the number of patients who are considered an overall success (e.g., when the primary endpoint is 
a composite of several parameters). 
 
Table 7 illustrates one way of presenting patient success results for a spinal system study.  A 
similar table may be constructed for studies of other types of implants.  In some cases, the 
protocol dictates that safety parameters comprise part of a composite overall patient and study 
success. 
 
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Table 7  Effectiveness Data Summary Table for Spinal System Study  
  6 wks  3 mo  6 mo  12 mo  24 mo  26+ mo 
  I  C  I  C  I  C  I  C  I  C  I  C 
N (Expected)A                         
FusionB                         
Oswestry score                         
Neurologic status                         
Disc height                         
Back pain                         
Leg Pain                         
SF-36 Physical                          
SF-36 Mental                         
Overall Success                         
I = investigational group; C = control group 
AThe number of patients expected at each timepoint in the top row.  If the number of patients 
evaluated differs from the N in any specific category the number of patients evaluated in that 
category should be provided in the denominator for each parameter. 
BThe number of patients (not the percentage)/number of patients evaluated who meet the 
success criteria for each endpoint at each timepoint are entered into the chart.   
 
8.  Elements of Clinical Data Presentations 
We included the following descriptions of the elements used in this document to encourage 
consistency and enhance understanding between FDA and sponsors through a consistent 
vocabulary when discussing and presenting clinical data.  In some instances, the definitions 
include FDAs recommendations that apply to the presentation formats exemplified above. 
 
Theoretical Follow-up - The theoretical follow-up is the number of implants that would have 
been examined if all patients returned on the exact anniversary of their respective initial surgery 
dates.  The theoretical follow-up is determined by selecting a date of database closure.  This is 
the date the database was closed to the addition of information.  Having selected a date of 
database closure you can determine the theoretical follow up.  For each implant in the 
investigation, you should determine the time difference between implantation and the date of 
closure.  Knowing this, you can determine which of the scheduled follow-up examinations the 
patient should have attended.  This process is repeated for each implant enrolled in the 
investigation.  The number of implants that should have been examined at each scheduled 
follow-up visit is summed, and this number is the theoretical follow-up for each timepoint. 
 
To permit data gathered from the patients up to the date of database closure to be entered into the 
report, the common practice is to select a date of closure in the recent past and report data 
collected up to that point.  We recommend that you include in the clinical report, any data 
recorded from an examination that took place on or before database closure, regardless of when 
you received it. 
 
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Deaths This element is the number of deaths that have taken place in the course of an 
investigation according to scheduled follow-up visit.  We recommend that you record the actual 
date of the patients death relative to the initial surgery in your narrative explaining the nature of 
the circumstances, if known, related to the patients death. 
 
Failures - This element is the number of failures that have taken place in the course of the 
investigational study recorded according to the scheduled follow-up visit.  We recommend that 
you define as a failure any result that would remove the patient from the study, such as a 
secondary intervention, severe adverse event, or other parameter that defines the device as 
ineffective or unsafe.  We also recommend that you distinguish this failure from an effectiveness 
failure that would not remove the patients from the study prior to the endpoint.  Some patient 
effectiveness results are determined failures only at the 24-month period (or study endpoint), but 
these would not affect the accounting table.  We recommend that you record these in the final 
result table.  You should record study failures in the various timepoints in the same manner as 
deaths.   
 
Not yet overdue - Patients in this category are those within the evaluation time window who 
have not been evaluated yet.  For example, a patient who has not yet been evaluated and is 22 
months post-operative is in the 24-month follow-up, but can be evaluated up to the 26-month 
timepoint and, thus, is not yet overdue.  This category only applies in the case of early database 
closure for some statistical analyses plans.  In cases where the not yet overdue category 
applies, we recommend that you add an additional row in the accounting table (Table 2). 
 
Actual - The number of patients actually evaluated during the follow-up window.  For example, 
the 24-month timepoint includes the number of patients evaluated between 22 and 26 months 
postoperatively.  For each evaluated patient, you should have data for each safety and 
effectiveness endpoint of interest in the study, collected per the protocol to be considered in this 
category.  For example, if there is a composite success-failure criterion, which includes pain, 
function, and radiographs, a patient should have documentation of all of this data to be 
considered evaluated and a part of the group with actual follow-up.  If a patient is evaluated at 
a time interval but the evaluation does not contain a complete set of data, or is considered to be a 
protocol violation, this patient is not included in this category in this table.  See table 2 above 
for a sample of an all evaluated accounting table, which includes these patients in the row 
titled evaluated.  
 
Expected - This element is the number of patients expected for a given time interval.  These 
include the theoretical number of patients who are due to be evaluated, less the number of 
patients who died or who were considered failures in that time interval:  
 
Theoretical  [Deaths + Failures] = Expected   
 
For certain statistical plans, we recommend that you also subtract the patients Not Yet Overdue 
from the Theoretical to obtain the Expected: 
 
Theoretical  [Deaths +Failures + Not yet overdue] = Expected   
 
We recommend that Expected include patients lost to follow-up in all study designs. 
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Follow-up rate - This element is the ratio of actual patients evaluated to expected patients.  The 
follow-up rate = Actual / Expected X 100, expressed as a percentage. 
 
Revision - A revision is a procedure that adjusts or in any way modifies or removes part of the 
original implant configuration, with or without replacement of a component.  A revision may 
also include adjusting the position of the original configuration.  This may include removing a 
component of a joint implant, such as a liner of a hip system, and only replacing that single 
component.  A revision may also include, in the case of a spinal system, removal or repositioning 
of one of two cages that subsided or migrated without complete removal of both devices and 
graft. 
 
Removal - A removal is a procedure where all of the original system configuration is removed 
with or without replacement due to, for example, mechanical failure of the device, pain, or 
infection. 
 
Reoperation - A reoperation is any surgical procedure that does not include removal, 
modification, or addition of any components to the system (e.g., drainage of a hematoma at the 
surgical site). 
 
Supplemental fixation - A supplemental fixation is a procedure in which additional 
instrumentation not under study in the protocol is implanted (e.g., supplemental placement of a 
rod/screw system with a spinal fusion system, cerclage wiring with a hip implant). 
 
Other interventions - This category includes other surgeries the patient incurs while enrolled in 
the study that seemingly are unrelated to the implanted device.  We recommend that you define 
the types and timing of these surgeries. 
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