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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database
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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Fusion, AEs, Surg Procedures


 
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General
Study Status Terminated
522 Number / Requirement Number PS090008 / PSS001
Date Original Plan Accepted 03/25/2011
Date Current Plan Accepted 04/18/2014
Study Name Fusion, AEs, Surg Procedures
Device Name Cd horizon® peek rods
Root Document Number K050809  K063670 
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source Other Data Source
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives 2 arm- retrospective cohort study. The data for the study will be obtained from patient medical records after applying inclusion/exclusion criteria. The data for analysis will be extracted from 112 patient records with PEEK rods (investigational device) and 112 control patient records with titanium rods. The time frame for this retrospective review of records will include surgeries occurring between September 15, 2005 tp March 5, 2011.
Study Population Patients who have received PEEK or titanium rods for posterior non-cervical fixation as an adjunct to posterolateral fusion for spondyloslisthesis, trauma, spinal stenosis, or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, tumor, pseudoarthrosis, and/or failed previous fusion.)
Sample Size "112 controls and 112 investigational. The total number of sites selected will depend on the number of subject cases that can be included per site in order to reach the 224 subjects
needed for the primary endpoint. There will be a minimum of 5 and up to 20 centers. "
Key Study Endpoints Fusion, adverse events, surgical procedures
Follow-up Visits and Length of Follow-up "Pre-operative assessments (60 days or less from sugery). The postoperative evaluations for the primary study endpoint will be reviewed from 6 months up to 24 months, if available, or until the last
observation on the subject, or until device failure, or until a subsequent surgical procedure is performed at the index level(s). All available postoperative safety data, regardless of time point, will be reviewed for each subject up to 24 months postsurgery. "


Fusion, AEs, Surg Procedures Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/23/2011 09/26/2011 On Time
1 year report 03/22/2012 03/22/2012 On Time
18 month report 09/22/2012 09/17/2012 On Time
2 year report 03/23/2013 03/20/2013 On Time
3 year report 03/22/2014 03/19/2014 On Time
4 year report 03/21/2015 03/20/2015 On Time
5 year report 03/21/2016 03/18/2016 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources
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