BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI LOCKING SCREW 12MM F/LOCKING RECONSTRUCTION PLATE

    MDR report key: 1190053 · Received October 6, 2008

    Report

    Report Number
    1719045-2008-00134
    Event Type
    Injury
    Date Received
    October 6, 2008
    Report Date
    September 12, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K033975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURE DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    TWO (2) 2.4MM TI LOCKING SCREWS, IMPLANTED WITH A PLATE ABOUT 3 MONTHS AGO FOR A MANDIBULAR DEFECT, BROKE POST OPERATIVELY. PATIENT WAS RETURNED TO THE OR, THE SURGEON REMOVED THE BROKEN SCREWS HEADS, LEFT THE SHAFTS IN PLACE, RE-CONTOURED THE SAME PLATE AND COMPLETED THE REVISION PROCEDURE SUCCESSFULLY. THE SCREW HEADS WERE DISCARDED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4MM TI LOCKING SCREW 12MM F/LOCKING RECONSTRUCTION PLATE LOCKING SCREWS HWC SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS| PLATE