BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 20733352 · Received November 20, 2024

    Report

    Report Number
    20733352
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    September 18, 2024
    Report Date
    September 19, 2024
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HBE
    UDI-DI
    07613327294989
    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

    DURING THE SURGERY, ONE OF THE STRYKER CARBIDE MATCH HEAD/BUR WITH REF OF 5820-107-530C LOT# 24193047 GOT BROKEN AND THE TIP OF THE BUR GOT RECOVERED BUT THERE ARE SOME FRAGMENTS STAYED IN THE BODY DUE TO ITS MICROSCOPIC SIZE, SURGEON DID X-RAY AND HE'S AWARE OF IT AND DECIDED TO CLOSE THE SURGICAL SITE BECAUSE THERE'S NO WAY TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481267 N/A DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS 5820107530C 24193047 07613327294989

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female