BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLAR BEARING PLATE, 3-HOLE, LT

    MDR report key: 22925953 · Received August 29, 2025

    Report

    Report Number
    2031009-2025-00023
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 29, 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

    SALES REP REPORTED ON 03AUG2025 THAT THE DISTAL SCREWS COLLAPSED IN A VBEAL-3-7S. ORIGINAL IMPLANT DATE IS UNKNOWN. ADDITIONAL INFORMATION WAS PROVIDED ON 12AUG2025 WHERE THE REP STATED NO DEVICES BROKE, THIS WAS NOT A REMOVAL SURGERY, THE DEVICE REMAINS IMPLANTED AND THERE WAS NO REPORTED ADVERSE EVENT. A SECOND FOLLOW-UP ON (B)(6) 2025 INDICATED THAT THERE IS NO REVISION SURGERY PLANNED, THERE IS NO PATIENT DISCOMFORT AND THE SURGEON BELIEVES THE PATIENT WILL HEAL PROPERLY WHILE LEAVING THE PLATE INSITU. TRIMED FOLLOWED UP AGAIN ON (B)(6) 2025 TO GATHER ADDITIONAL X-RAYS AND MORE INSIGHT ON HOW THIS ISSUE WAS DISCOVERED BY THE SURGEON. AN X-RAY WAS PROVIDED ON (B)(6) 2025, WHICH SHOWS THE PLATE IS PARTIALLY FIXED TO THE BONE WITH NO DETAILS ON THE DATE AND TIME OF THE X-RAY. PLATE STILL REMAINS IMPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164506 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