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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

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Study Status Completed
Application Number P060018 / PAS002
Date Current Protocol Accepted 07/16/2007
Study Name OSB Lead-Enhanced Surveillance
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 PRESTIGE device up to 5 years after device approval
Study Population Description Study includes all patients who received Prestige Cervical Disc after device approval as per device indication. This device is indicated indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. Intractable radiculopathy and/or myelopathy should present with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (e.g., pain [neck and/or arm pain], functional deficit, and/or neurological deficit), and radiographic studies (e.g., CT, MRI, x-rays, etc.): 1) herniated disc, and/or 2) osteophyte formation. The PRESTIGE 9 device is implanted via an open anterior approach.
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 During the period of December 11, 2008 through June 15, 2009, the Sponsor has received 8 complaints related to the device and 5 resulted in the filing of MDRs.
Actual Number of Patients Enrolled n/a
Actual Number of Sites Enrolled n/a
Patient Follow-up Rate n/a
Final Safety Findings Since the PMA approval date of July 16, 2007 through May 13, 2012, a cumulative total of implants have been sold in the U.S., a cumulative total of MDRs have been reported for implants sold in the U.S., and a cumulative total of MDRs have been reported for instruments sold in the U.S.

A Kaplan-Meier analysis was conducted on adverse events and second surgeries reported from PMA approval on July 16, 2007 through May 13, 2012. events were included in the time-to-adverse event analysis, with cumulative event rates of 0.413% at months, 0.479% months, 0.479% months, and 0.598%. events were included in the time-to-second surgery analysis, with cumulative event rates of 0.124% at months, 0.190% at months, 0.190% at months, and 0.309% at months and beyond following surgery

Final Effect Findings n/a
Study Strengths & Weaknesses

The study duration was for 5 years after PMA approval, allowing time to monitor adverse events and complaints received by the company for the device in the postmarket 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. Therefore, the true number of devices implanted during the 5-year study period is unknown.

Recommendations for Labeling Changes

A labeling change based on the results from this study is not recommended because the study was designed as a surveillance study.

OSB Lead-Enhanced Surveillance Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report (Enhanced Surveillance Study) 01/14/2008 01/14/2008 On Time
1 Year report (Enhanced Surveillance Study) 07/31/2008 07/15/2008 On Time
18 month report (Enhanced Surveillance Study) 01/13/2009 01/12/2009 On Time
2 year report (Enhanced Surveillance Study) 07/15/2009 07/21/2009 Overdue/Received
3 year report (Enhanced Surveillance Study) 07/15/2010 07/20/2010 Overdue/Received
4 year report (Enhanced Surveillanced Study) 07/15/2011 07/18/2011 Overdue/Received
5 year report (Final)(Enhanced Surveillance Study) 07/14/2012 07/13/2012 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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