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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Time to Revision and Explant Analysis


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS110003 / PSS001
Date Current Plan Accepted 11/08/2019
Study Name Time to Revision and Explant Analysis
Root Document Number P980052 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective 1: Survival Analysis- Prospective Cohort. To determine the survival rate for revision and/or removal of TMJ Concepts implants and use this data to determine factors that affect this survival during three years of follow-up. This will answer questions 1-3 and question 5b. Objective 2: Reason for Failure Analysis-cross-sectional study. To determine the reasons for TMJ implant revisions and removals among patients who have had TMJ Concepts implants. This will answer question 4. Objective 3: Explant Analysis. To determine the specific modes and causes of failure based on an analysis of all reasonably available explanted retrieved TMJ Concepts devices. This will answer question 5a.

Study Population Description 18 to 21 yrs; Adult 21+

Sample Size 672 patients

Data Collection 1. Survival Analysis: Revision or removal at three years of follow-up; Revision or removal for subgroups of patients. 2. Reason for failure analysis: Reasons for initial and subsequent revision or removal. 3. Explant Analysis; TMJ implant failure.

Follow-up Visits and Length of Follow-up FU Visits: Annually; Length of FU: 3 years



Time to Revision and Explant Analysis Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/01/2013 11/13/2013 Overdue/Received
12 month report 04/01/2014 03/31/2014 On Time
18 month report 09/30/2014 09/30/2014 On Time
2 year report 04/01/2015 04/02/2015 Overdue/Received
3 year report 04/01/2016 04/04/2016 Overdue/Received
4 year report 04/03/2017 06/12/2017 Overdue/Received
5 year report 04/01/2018 03/12/2019 On Time
Final Report 01/20/2020 01/21/2020 Overdue/Received


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