BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 24808393 · Received April 7, 2026

    Report

    Report Number
    1644408-2026-00565
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    KWS
    UDI-DI
    00190446844150
    PMA / PMN Number
    K233481
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE

    Description of Event or Problem · 0

    INSTRUMENT FAILURE - UPON INSERTING THE ARG BASEPLATE, THE LONG PEG ON THE INSERTER BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537335 DJO SURGICAL ALTIVATE REVERSE GLENOID BASEPLATE INSERTER, WEDGE KWS ENCORE MEDICAL L.P. 442067L02 00190446844150

    Patients

    Seq Age Sex Outcome Treatment
    1