BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINICA

    MDR report key: 1891410 · Received October 15, 2010

    Report

    Report Number
    1891410
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING FIXATION PINS WHILE PLACING THE CERVICAL PLATE. WHEN THE SURGEON REMOVED THE PIN FROM THE LEFT SIDE OF THE PLATE, THE PIN WAS FOUND TO BE BROKEN IN TWO PIECES. BOTH PIECES OF THE PIN WERE RETRIEVED AND ALL PARTS APPEARED TO BE ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA APPLICANCE, FIXATION, TEMPORARY FIXATION SCREW KWQ ZIMMER SPINE * 61408140

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR