BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLAR BEARING PLATE, 3-HOLE, LT

    MDR report key: 22688403 · Received August 1, 2025

    Report

    Report Number
    2031009-2025-00020
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    July 9, 2025
    Report Date
    August 1, 2025
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    UDI-DI
    00842188124938
    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 09JUL2025 THAT WHEN THE SURGEON WAS REMOVING A VBEAL-3-7S, THE DISTAL SCREWS IN THE PLATE WOULD NOT DISENGAGE FROM THE BEARINGS. IT WAS REPORTED THAT THIS CAUSED A SIGNIFICANT DELAY IN THE CASE (OVER 20 MINS). THE SURGEON WAS ABLE TO EVENTUALLY REMOVE THE PLATE EVEN THOUGH ALL SCREWS WERE NOT ABLE TO DISENGAGE. ADDITIONAL INFORMATION WAS RECEIVED ON 22JUL2025 WHICH THE REP STATED THE SURGEON SUSPECTS THE PATIENT DID FALL POST-OP. HE DIRECTED THIS INQUIRY TO THE PATIENT, HOWEVER, THE PATIENT DENIED THIS OCCURRED. THE SURGEON ALSO NOTICED THE PATIENT WAS NO LONGER WEARING HIS SPLINT WHEN HE ARRIVED FOR A POST-OP VISIT WHICH THE SURGEON THOUGHT WAS SUSPICIOUS. THE SURGEON REVEALED HE GAVE THE PATIENT SPECIFIC INSTRUCTIONS TO NOT REMOVE THE SPLINT. FINALLY, IT WAS CONFIRMED THAT THERE WAS CAUSE FOR REMOVAL OF THE PLATE. X- RAYS AND CLINIC NOTES FROM PHYSICAL EXAM ON (B)(6) 2025 IDENTIFIED LOSS OF FIXATION AS WELL AS PROMINENCE ON THE DISTAL END OF THE VOLAR BEARING PLATE. THE FRACTURE HAD HEALED IN A POOR POSITION BECAUSE OF HARDWARE FAILURE WHICH CAUSED PATIENT DISCOMFORT. ALSO, THE SURGEON REPORTED DURING REMOVAL THE DISTAL ROW OF SCREWS APPEARED MISALIGNED FROM THEIR ORIGINAL PLACEMENT MAKING SCREW HEAD ACCESS DIFFICULT. HE CONCLUDED MISALIGNMENT IMPLIED FAILURE OF THE BEARINGS WITHIN THE VOLAR PLATE. THE SURGEON ULTIMATELY REPLACED THE HARDWARE WITH MEDARTIS ADAPTIVE II TRILOCK VOLAR DISTAL RADIUS PLATE. PICTURES AND X-RAYS WERE PROVIDED AND THE DEVICE IS AVAILABLE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280 VOLAR BEARING PLATE, 3-HOLE, LT VOLAR BEARING PLATE, 3-HOLE, LT HRS TRIMED, INC. VBEAL-3-7S ME24057 00842188124938

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown