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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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Retrieval Analysis

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Study Status Progress Adequate
Application Number P110002 / PAS003
Date Current Protocol Accepted 07/15/2014
Study Name Retrieval Analysis
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source Other Data Source
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description Retrieval Analysis: to asses device failure modes or adverse event profile with a possible relationship to the clinical and demographic characteristic (if the data permits) for one and two level patients with the device.
Design-case series (if clinical data is available) premarket cohorts, new enrollment or both.
Study Population Description All patients with Mobi-C Cervical Disc whose device has been removed and subjected to retrieval analysis.
Sample Size NA (bench study)
Data Collection Implant Failure Modes
Adverse Event Profile
Possible relationship of the mechanical wear to the clinical characteristics of the patient (if data is available)
Follow-up Visits and Length of Follow-up 10 years f/u
Interim or Final Data Summary
Interim Safety Information Currently, there is no evidence to indicate a systemic clinical problem with the Mobi-C mobile insert due to oxidation. There have been no trends identified between the retrieved devices and reasons for device removal
Actual Number of Patients Enrolled N/A- Information will be collected from reports of device removals and thorough analysis of the retrieved devices.
Actual Number of Sites Enrolled N/A- Information will be collected from reports of device removals and thorough analysis of the retrieved devices.
Patient Follow-up Rate Since the 2018 Retrieval Analysis Report, 8 devices have been retrieved from 5 patients
Study Strengths & Weaknesses N/A

Retrieval Analysis Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 08/08/2014 08/08/2014 On Time
one year report 08/15/2015 08/17/2015 Overdue/Received
two year report 08/15/2016 08/15/2016 On Time
three year report 08/15/2017 08/14/2017 On Time
four year report 08/15/2018 08/15/2018 On Time
five year report 11/07/2019 11/07/2019 On Time
six year report 11/07/2020 11/09/2020 Overdue/Received
7 year report 11/06/2021 11/18/2021 Overdue/Received
8 year report 11/06/2022    

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