BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES INC.

    MDR report key: 890969 · Received August 3, 2007

    Report

    Report Number
    MW5003316
    Event Type
    Injury
    Date Received
    August 3, 2007
    Date of Event
    July 25, 2007
    Report Date
    August 3, 2007
    Manufacturer
    SYNTHES INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PT WENT FOR AN ARCH BAR PLACEMENT AND INTERMAXILLARY FIXATION, MIDFACE DEGLOVING WITH OPEN REDUCTION AND INTERNAL FIXATION OF MIDFACE FRACTURES, RIGHT LATERAL ORBITOTOMY WITH REMOVAL OF FOREIGN BODY/BONE AND OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT ORBITAL RIM FRACTURES. WHILE PLACING THE SCREWS, TWO OF THE SCREWS, THEIR HEADS BROKE OFF AND THEY WERE NOT ABLE TO RETRIEVE ONE OF THE SCREW'S END FROM THE BONE. A THIRD SCREW WAS ATTEMPTED AND THIS ONE DID WELL. THE PT HAS NOT SUFFERED ANY SEQUELA FROM THIS AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES INC. SCREWS HWC SYNTHES INC. H98040062809 SCREW

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability