BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLAR BEARING PLATE, 3-HOLE, RT

    MDR report key: 22438757 · Received July 8, 2025

    Report

    Report Number
    2031009-2025-00015
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 8, 2025
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    UDI-DI
    00842188125027
    PMA / PMN Number
    K222637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A SALES REP REPORTED ON 10JUN2025 THAT A SURGEON HAD TWO WS3 VOLAR BEARING PLATE FAILURES WHERE HE INDICATED HE THOUGHT THE BEARING WASN'T LOCKING INTO THE PLATE PROPERLY. A SALES REP PROVIDED ADDITIONAL INFORMATION ON 25JUN2025 WITH X-RAYS FOR BOTH CASES AND THE DEVICES WERE IDENTIFIED AS THE VBEAR-3-7S AND VBEAR-5-7S. THE SURGEON REPORTED THAT THERE WERE NO POST-OP INJURIES AND NO ASSOCIATED CO-MORBIDITIES. REVISION SURGERY WAS AFTER 3 MONTHS FOR THE 1ST PATIENT, VBEAR-3-7S (EXACT IMPLANT DATE AND REMOVAL DATE UNK) AND 4 MONTHS AFTER FOR THE SECOND PATIENT VBEAR-5-7S (EXACT IMPLANT DATE AND REMOVAL DATE UNK). IT WAS OBSERVED THROUGH X-RAY PHOTOS PROVIDED THAT THE PROXIMAL ROW OF THE PLATE DID NOT HAVE ANY SCREWS IMPLANTED. THE SURGEON STATED THAT DURING THE INITIAL SURGERY THE BEARINGS WERE LOCKED AT THE END OF BOTH CASES. FINALLY, IT WAS REPORTED THAT THE 1ST PATIENT HAD ADDITIONAL SURGERY TO REMOVE THE PLATE AND THE 2ND PATIENT RUPTURED HER FPL TENDON WHICH WILL REQUIRE RECONSTRUCTION OF THE TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399666 VOLAR BEARING PLATE, 3-HOLE, RT VOLAR BEARING PLATE, 3-HOLE, RT HRS TRIMED, INC. VBEAR-3-7S 00842188125027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention