f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Enhanced Surveillance


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General
Study Status Completed
Application Number /
Requirement Number		 P100003 / PAS002
Date Original Protocol Accepted 09/28/2012
Date Current Protocol Accepted 05/08/2014
Study Name Enhanced Surveillance
Device Name SECURE-C ARTIFICIAL CERVICAL DISC
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives Objectives-To assess safety profile of the secure-C disc under general condition of use. Design- ESS
Study Population All patients who have received secure-C
Sample Size N/A
Key Study Endpoints Anticipated and un-anticipated adverse events including, but
not limited to major vessel injury, neurological damage, or nerve injury, device migration, removal, revision, and heterotopic codification.
Follow-up Visits and Length of Follow-up 10 years
Assessments: Annual for surgeon surveys, ongoing for the complains, explants and MDRs
Interim or Final Data Summary
Actual Number of Patients Enrolled Not applicable
Actual Number of Sites Enrolled Not applicable
Patient Follow-up Rate Not applicable
Final Safety Findings A cumulative total of 7318 implants have been sold in the U.S. since the PMA approval date of September 28, 2012, to September 13, 2022. A cumulative total of 78 MDRs have been reported for the SECURE-C system sold in the U.S. since the approval date to September 13, 2022. 74 of the US MDRs were device related while 4 were instrument related. A cumulative total of 594 implants have been sold outside of the U.S. since the PMA approval date of September 28, 2012, to September 13, 2022. A cumulative total of 1 MDRs have been reported outside of the U.S since the approval date to September 13, 2022, and it was instrument related.
Final Effect Findings Not applicable
Study Strengths & Weaknesses The study permitted monitoring of the AEs occurrence in the broader population of the device users.
Due to the study design, it is impossible to meaningfully evaluate the AEs rates. Further, due to study design and lack of clinical information reported to the company it is difficult to find any particular trends in occurrence of heterotopic ossification and osteolysis.
Recommendations for Labeling Changes Yes


Enhanced Surveillance Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/29/2013 03/28/2013 On Time
1 year report 09/28/2013 09/27/2013 On Time
18 month report 03/29/2014 03/28/2014 On Time
2 year report 09/28/2014 09/26/2014 On Time
3 year report 09/28/2015 09/30/2015 Overdue/Received
4 year report 09/27/2016 09/28/2016 Overdue/Received
5 year report 09/27/2017 09/28/2017 Overdue/Received
6 year report 09/27/2018 09/27/2018 On Time
7 year report 09/27/2019 09/26/2019 On Time
8 year report 09/27/2020 09/25/2020 On Time
9 year report 09/28/2021 09/28/2021 On Time
final report 09/28/2022 09/27/2022 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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