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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 System


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General
Study Status Completed
Application Number /
Requirement Number		 P110002 / PAS002
Date Original Protocol Accepted 05/16/2014
Date Current Protocol Accepted 06/03/2014
Study Name Enhanced Surveillance System
Device Name MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)
Clinical Trial Number(s) NCT00389597 
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 yrs < 22 yrs, Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives A 10-year Enhanced Surveillance Study (ESS) of the Mobi-C® Cervical Disc Prosthesis to fully characterize adverse events
and complaints when the device is used in the intended patient population under general conditions of use in the United States and in the rest of the world.
The objective is to collect, analyze, and submit all adverse event data.
Study Population All patients who are implanted with the device
The data on AEs will be collected by the company and reported to the FDA:
1. Through literature search (every 6 months for first 2 years and then annually thereafter)
2. AEs reported through company website
3. MDR reports
4. Annual survey of all USA physicians who were trained with the device
Sample Size N/A
Key Study Endpoints All adverse Events will be reported including HO, neurological complications, subsequent surgeries and etc. The data will be
categorized based on severity, and device and MDR relevancy.
Follow-up Visits and Length of Follow-up 10 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 3246 surgeons sent 21854 surveys
Actual Number of Sites Enrolled N/A
Annual surgeon survey: active collection of surgeon feedback annually to elicit information
related to heterotopic ossification, device malfunction, device removal, or other serious device related
complications.
Patient Follow-up Rate 15.5% survey response rate
Final Safety Findings No new questions of safety or raised. Highest AE rates regarded device positioning or migration, heterotopic ossification, continuing pain, and general technical difficulty with the surgery. The sum total of all AE responses was 0.61%.
Final Effect Findings This Enhanced Surveillance Study did not survey effectiveness.
Study Strengths & Weaknesses Returns represent a small percentage of patients
Recommendations for Labeling Changes No labeling change is recommended


Enhanced Surveillance System Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/05/2014 02/04/2014 On Time
1 year report 08/07/2014 08/07/2014 On Time
18 month report 02/05/2015 02/09/2015 Overdue/Received
2 year report 08/07/2015 08/10/2015 Overdue/Received
3 year report 08/06/2016 08/08/2016 Overdue/Received
4 year report 10/06/2017 10/06/2017 On Time
5 year report 11/06/2018 11/06/2018 On Time
6 year report 11/06/2019 11/06/2019 On Time
7 year report 11/06/2020 11/09/2020 Overdue/Received
8 year report 11/06/2021 11/08/2021 Overdue/Received
9 year report 11/06/2022 11/07/2022 Overdue/Received
10 year report 11/06/2023 11/07/2023 Overdue/Received
final report 02/06/2025 01/28/2025 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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