BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN PLUG SCREW 8MM

    MDR report key: 378774 · Received February 21, 2002

    Report

    Report Number
    9610622-2002-00012
    Event Type
    Malfunction
    Date Received
    February 21, 2002
    Date of Event
    January 20, 2002
    Report Date
    January 22, 2002
    Manufacturer
    STRYKER TRAUMA GMBH
    Product Code
    HSB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON PLOOSTER ATTEMPTED TO INSERT ROD CAP SCREW AFTER PROXIMAL CROSSLOCKING WAS PERFORMED. HE ATTEMPTED TO THREAD THE ROD CAP SCREW INTO THE PROXSIMAL END OF TIBIAL NAIL CAT# 1822-0933S LOT CODE #K902896. TOTAL ADDITIONAL ANESTHESIA TIME WAS APPROXIMATELY 5 MINUTES. A SIMILAR CAP SCREW WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCE TO TH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAN PLUG SCREW 8MM IMPLANT HSB STRYKER TRAUMA GMBH NA K934538

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other