BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINEMATX TOTAL

    MDR report key: 22387125 · Received July 2, 2025

    Report

    Report Number
    3007289093-2025-00006
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    May 13, 2025
    Report Date
    July 2, 2025
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    JWJ
    PMA / PMN Number
    K191525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW USED IN THE ORIGINAL SURGERY WAS TOO LONG. A REVISION WAS DONE TO SWAP THE SCREW FOR A SMALLER SIZE. IT SEEMS THAT THE SCREW MAY HAVE BEEN BACKING OUT AS WELL WHICH WAS NOT REALIZED UNTIL INTRA-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142284 KINEMATX TOTAL WRIST ARTHROPLASTY JWJ EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention