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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 PS090015 / PSS001
Date Original Plan Accepted 02/17/2012
Date Current Plan Accepted 05/21/2013
Study Name Fusion, AEs, Surg Procedures
Device Name Modified vertiflex spinal screw system (with dynabolt rods)
Root Document Number K073143 
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 "Prospective single-arm multi-center (up to 6 sites) cohort study with literature control. Investigational patients will be enrolled in consecutive fashion. The performance of the investigational device, Silverbolt® Spinal System with Dynabolt® Rods, will be compared to the rate of fusion, as described in published scientific literature."
Study Population Patients with the device for bilateral (left and right) posterolateral fusions of the thoracic, thoracolumbar, lumbar, or lumbosacral spine using autogenous bone only.
Sample Size 171 patients, 6 sites
Key Study Endpoints Fusion, Adverse events, surgical procedures
Follow-up Visits and Length of Follow-up At 12 and 24 months post-treatment; the recruitment period is estimated to be 12 months with anticipated clinical investigation duration of 36 months.


Fusion, AEs, Surg Procedures Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 Yr Report 02/16/2013 02/22/2013 Overdue/Received
18 month report - revised timeline 08/17/2013 08/21/2013 Overdue/Received
2 year report 02/16/2014 03/13/2014 Overdue/Received
3 year report 02/16/2015 02/12/2015 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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