BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1081228 · Received July 23, 2008

    Report

    Report Number
    2520274-2008-00056
    Event Type
    Injury
    Date Received
    July 23, 2008
    Report Date
    July 1, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE AND MANUFACTURING DATE WITHOUT A LOT NUMBER. NUMBER CANNOT BE DETERMINED WITHOUT A PART NUMBER OR COMMON DEVICE NAME. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT PLANNED HARDWARE REMOVAL AFTER FRACTURE HEALING DUE TO IRRITATION FROM DISTAL END OF PLATE. DURING REMOVAL, THE SURGEON WAS UNABLE TO DISENGAGE THE SCREWS FROM THE PLATE. THE SURGEON CUT 1/3 OF THE PLATE AND SEVERED THREE SCREWS. UPON REMOVAL OF THESE DEVICES, THE SCREWS WERE NOTED TO REMAIN ENGAGED WITH THE PLATE. THE SURGEON WAS UNABLE TO EXPLANT THE REMAINING SCREWS AND PORTION OF PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI NI KWQ SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS