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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Explant Analysis Study Plan


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS110002 / PSS006
Date Current Plan Accepted 03/16/2016
Study Name Explant Analysis Study Plan
Root Document Number P000023  P000035 
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Design Description This protocol will be applied to all explanted devices that are returned to Nexus CMF for four years from implementation of this protocol, whether or not the patient has been included in the prospective study.
Study Population Description All explanted devices that are returned to Nexus CMF for implantation of either a TMJ Fossa- Eminence and Condylar Prosthesis System or a TMJ Fossa- Eminence Prosthesis System.

Sample Size All explanted devices that are returned from the 278 subjects subjects for the Total Joint System and 278 subjects for the Partial Joint System.

Data Collection The study endpoints will include:

• Summary of clinical information.

• Summary of the dimensional analysis.

• Summary of the visual inspection including overall photographs along with photographs of areas of damage and/or wear.

• Summary of the profilometry measurements.

• Summary of scanning electron microscopy (SEM) and electron dispersion x-ray spectophotometry (EDS) analyses.

• Wear measurements.

• Summary of tissue analysis (if performed).

• Determination as to the cause of failure of the device

(if possible based on available information).

Follow-up Visits and Length of Follow-up 4 years


Explant Analysis Study Plan Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/14/2016 09/16/2016 Overdue/Received
1 year report 03/16/2017 03/20/2017 Overdue/Received
18 month report 09/14/2017 02/01/2019 Overdue/Received
2 year report 03/16/2018   Overdue
3 year report 03/16/2019   Overdue
4 year report 03/15/2020   Overdue
5 year report 03/15/2021    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov
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