BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLAR BEARING PLATE, 3-HOLE, LT

    MDR report key: 22079965 · Received May 23, 2025

    Report

    Report Number
    2031009-2025-00009
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 23, 2025
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    UDI-DI
    00842188124938
    PMA / PMN Number
    K222637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A SALES REP REPORTED ON 29APR2025, THAT WHILE REVIEWING POST-OP X-RAYS ON (B)(6) 2025 THE SURGEON NOTICED THE BEARINGS ON THE VBEAL-3-7S HAD COLLAPSED. IT WAS REPORTED THAT THE INTRA-OP X-RAYS TAKEN ON (B)(6) 2025 LOOKED GOOD FOR THE PLATE AND REVISION SURGERY DATE HAS NOT BEEN CONFIRMED. IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS PERFORMED BY A FELLOW WITH AN EXPERIENCED REP IN THE ROOM, THE PROXIMAL SCREWS WERE NOT IMPLANTED SINCE THE FELLOW FELT THE DISTAL ROW FIXATION WAS ADEQUATE AND BELIEVED ALL BEARINGS WERE LOCKED. IT WAS STATED THAT THE PATIENT WAS COMPLIANT WITH POST-OP INSTRUCTIONS. INTRA-OP AND POST-OP X-RAYS WERE PROVIDED BUT PRE-OP X-RAYS COULD NOT BE OBTAINED AND THE DEVICE REMAINS IMPLANTED UNTIL THE REVISION SURGERY IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060247 VOLAR BEARING PLATE, 3-HOLE, LT VOLAR BEARING PLATE, 3-HOLE, LT HRS TRIMED, INC. VBEAL-3-7S 00842188124938

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown