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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Enhanced Surveillance Study

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Study Status Completed
Application Number P070001 / PAS002
Date Current Protocol Accepted 08/12/2008
Study Name OSB Lead-Enhanced Surveillance Study
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an enhanced surveillance system to collect the patietns demographic, clinical and device information for all complaints and adverse events (both MDR and non-MDR) possibly related to the Pro-Disc device up to 5 years after device approval
Study Population Description Study population is as per device approval. The study includes all patients who received Prodisc after device approval. This device is indicated for skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a ftmctional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI, or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The ProDiscTM-C Total Disc Replacement is implanted via an open anterior approach. Patients receiving the ProDiscTM-C Total Disc Replacement should have failed at least six weeks of non-operative treatment prior to implantation of the ProDiscTM-C Total Disc Replacement.
Sample Size n/a
Data Collection Complaints and Adverse events
Follow-up Visits and Length of Follow-up up to 5-year after device approval
Interim or Final Data Summary
Interim Safety Information From the December 17, 2007 approval of the ProDisc-C device, through December 7, 2009, Synthes has received a total of 65 complaints for this device. Fifteen complaints are currently being investigated internally and additional information will be provided to the agency as it becomes available. Forty-three of the complaints were determined to be MDR reportable. Eight complaints were determined as "non-valid".
Actual Number of Patients Enrolled Not applicable this is Enhanced surveillance investigation
Actual Number of Sites Enrolled Not applicable this is Enhanced surveillance investigation
Patient Follow-up Rate Not applicable this is Enhanced surveillance investigation
Final Safety Findings Since the PMA approval of December 17, 2007 through November 1, 2012,

theinformation on the cumulative total MDRs (n=214) and device sales has been collected and evaluated. During 60-monthds of the study period, no

unanticipated adverse events were identified, and the device has not been withdrawn from any of the markets.

Final Effect Findings Not applicable this is Enhanced surveillance investigation
Study Strengths & Weaknesses The duration of the Enhanced Surveillance System was 5 years after PMA approval, allowing time to monitor longer term adverse events and complaints received by the company for the device in the post-market setting.

There may be under-reporting of adverse events and complaints to the company. Therefore, the true number of adverse events and complaints during the 5-year study period is unknown.

In addition, the total number of implants sold may be an overestimate of the number of devices actually implanted.

Recommendations for Labeling Changes No labeling change is recommended because the adverse events noted in the final report are not unanticipated.

OSB Lead-Enhanced Surveillance Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 06/16/2008 06/18/2008 Overdue/Received
1 year report 12/16/2008 12/17/2008 Overdue/Received
18 month report 06/16/2009 06/18/2009 Overdue/Received
2 year report 12/16/2009 12/31/2009 Overdue/Received
3 year report 12/16/2010 12/20/2010 Overdue/Received
4 year report 12/16/2011 12/14/2011 On Time
5 year report-final report 12/15/2012 12/14/2012 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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