BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLAR PEG THREADED

    MDR report key: 11784420 · Received May 6, 2021

    Report

    Report Number
    2031009-2021-00003
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 7, 2021
    Report Date
    May 6, 2021
    Manufacturer
    TRIMED INC
    Product Code
    JDS
    PMA / PMN Number
    K951302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A TRIMED SALES REP REPORTED ON 22 APR 2021 THAT A REMOVAL SURGERY ON (B)(6) 2021 HAD TO BE PERFORMED ON A PATIENT THAT HAS HAD THE DEVICES IMPLANTED FOR 17 YEARS. THE REMOVAL WAS PROMPTED BECAUSE THE PATIENT BEGAN FEELING DISCOMFORT IN THE WRIST JOINT. DURING THE REMOVAL IT WAS DETERMINED THAT THE TWO SCREWS CAUSING THE JOINT DISCOMFORT WERE STRIPPED AND UNABLE TO BE REMOVED. THE SURGEON TRIED REMOVING THE SCREWS WITH TRIMED'S REMOVAL KIT AS WELL AS 2 OTHER COMPANIES REMOVAL KITS WITH NO SUCCESS. THE DEVICES REMAINED IMPLANTED AND WILL CONTINUE TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683675 VOLAR PEG THREADED VOLAR PEG THREADED JDS TRIMED INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention