BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNAMIC MESH STD FOR 1.5/1.7 MM SCREWS, 200 X 200MM X 0

    MDR report key: 1235688 · Received November 14, 2008

    Report

    Report Number
    8010177-2008-00085
    Event Type
    Other
    Date Received
    November 14, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 14, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    DZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER REP (B) (4), SURGEON WAS FIXATING A SCREW INTO THE MESH AND THE SCREW DISENGAGED FROM THE SCREWDRIVER BLADE AND THE BLADE WENT INTO THE TISSUE OF THE PT APPROX 3-4 CM. THE SURGEON THEN REMOVED THE BLADE AND MESH. STOPPED BLEEDING AND PACKED WITH JELL FOAM. THE SURGEON THEN USED A LARGE MESH AND FINISHED THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAMIC MESH STD FOR 1.5/1.7 MM SCREWS, 200 X 200MM X 0 IMPLANT DZL STRYKER OSTEOSYNTHESIS FREIBURG 0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention