BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINEMATX

    MDR report key: 17698173 · Received September 7, 2023

    Report

    Report Number
    3007289093-2023-00014
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 3, 2023
    Report Date
    September 7, 2023
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    JWJ
    UDI-DI
    00842078117033
    PMA / PMN Number
    K191525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW WAS BROKEN. A REVISION SURGERY SUCCESSFULLY REPLACED THE CARPAL COMPONENTS AND RADIAL BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926378 KINEMATX WRIST ARTHROPLASTY JWJ EXTREMITY MEDICAL, LLC. 00842078117033

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention