BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM TI CANCELLOUS LOCKING SCREW 26MM THRD LENGTH

    MDR report key: 638421 · Received September 29, 2005

    Report

    Report Number
    2530088-2005-00019
    Event Type
    Injury
    Date Received
    September 29, 2005
    Report Date
    August 16, 2005
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THREE OR FOUR SCREWS WERE REVEALED BY X-RAY TO HAVE BROKEN MIDSHAFT IN A ATB SACRAL SINGLE LEVEL PLATE. PT IS UNDERGOING POSTERIOR SPINAL FUSION IN 08/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM TI CANCELLOUS LOCKING SCREW 26MM THRD LENGTH LOCKING SCREWS HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention