BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER

    MDR report key: 19237926 · Received May 3, 2024

    Report

    Report Number
    19237926
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    November 27, 2023
    Report Date
    November 29, 2023
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A SMALL PIECE OF THE K-WIRE BROKE OFF INSIDE THE SACRAL 1 VERTEBRAL BODY AS THE SURGEON WAS ATTEMPTING TO IMPLANT A SCREW, THE SURGEON STATED THAT THE K-WIRE PIECE IS NOT RETREATABLE AND IT WILL STAY IN THE PATIENT¿S VERTEBRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277581 BRASSELER PIN, FIXATION, SMOOTH HTY BRASSELER U.S.A. MEDICAL, LLC NY1B7

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other