BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.6X40MM FULLY THD CROSS SCREW

    MDR report key: 454707 · Received April 16, 2003

    Report

    Report Number
    9610622-2003-00011
    Event Type
    Injury
    Date Received
    April 16, 2003
    Report Date
    October 23, 2002
    Manufacturer
    STRYKER HOWMEDICA KIEL TRAUMA GMBH
    Product Code
    HFZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NAIL WAS IMPLANTED IN THE PT IN 2002 WITH SUPERIOR AND INFERIOR LOCKING SCREWS. 3 MONTHS LATER IT APPEARS ON THE X-RAY THAT THE MEDIO-LATERAL SCREW IS BROKEN. THE BROKEN MEDIO-LATERAL BROKEN SCREW WAS TOTALLY REMOVED FROM THE PT, AND A PART OF THE ANTERO-POSTERIOR SCREW IS REMOVED TOO. THE BROKEN TIP OF THE ANTERO-POSTERIOR IS STILL IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.6X40MM FULLY THD CROSS SCREW IMPLANT HFZ STRYKER HOWMEDICA KIEL TRAUMA GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention