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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 PS090016 / PSS001
Date Original Plan Accepted 04/05/2011
Date Current Plan Accepted 11/05/2012
Study Name Fusion, AEs, Surg Procedures
Device Name Zimmer® dynesys® spinal system with dto implant
Root Document Number K031511  K071879  K071880 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives "This is a prospective observationalone arm cohort study. The fusion rate will be compared to the fusion rate reported in the literature. The hypothesis is that the Dynesys fusion rate at 24 months is noninferior to the historical literature sample data estimated fusion rate of 80.6%, with 0.1 of noninferiority margin."
Study Population The study population is comprised of patients who receive Dynesys Spinal System and meet the inclusion/exclusion criteria are eligible for enrollment.
Sample Size sites-6, patients 168
Key Study Endpoints Fusion, adverse events and surgical procedures
Follow-up Visits and Length of Follow-up The scheduled visits are planned at 6 months ± 4 weeks, 12 months, 24 months, and Annual Visits after 24 month until all patients have completed the study (± 8 weeks)


Fusion, AEs, Surg Procedures Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 Month Report 10/02/2011 10/04/2011 Overdue/Received
1 year report 04/03/2012 04/02/2012 On Time
18 month report 11/30/2012 10/03/2012 On Time
2 yr report 04/02/2013 04/02/2013 On Time
3 yr report 04/02/2014 04/02/2014 On Time
4 yr report 04/02/2015 04/03/2015 Overdue/Received
54 month report 10/02/2015 10/05/2015 Overdue/Received
66 month report 01/02/2016 12/31/2015 On Time
5 yr report 04/02/2016 04/04/2016 Overdue/Received


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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