BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLS

    MDR report key: 314440 · Received January 22, 2001

    Report

    Report Number
    MW1020964
    Event Type
    Malfunction
    Date Received
    January 22, 2001
    Date of Event
    January 19, 2001
    Report Date
    January 22, 2001
    Manufacturer
    KLS MARTIN L.P.
    Product Code
    NDK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY ON THE MANDIBLE, THE SCREW BROKE - ENTIRE THREAD SECTION (APPROX 15MM). THE PIECE WAS LEFT IN THE PT (EMBEDDED). PT SUFFERED NO INJURY.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/3/01: CO IS NOT THE MFR. CO HAS FORWARDED A COPY OF THE MED WATCH TO ACE SURGICAL SUPPLY CO WHO THEY PURCHASED THE PRODUCT FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2621 KLS EXTERNAL FIXATOR SCREW NDK KLS MARTIN L.P. 35 MM LENGTH *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other