BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM HEADLESS COMPRESSION SCREW

    MDR report key: 1843683 · Received September 21, 2010

    Report

    Report Number
    1719045-2010-00252
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Report Date
    August 24, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K080943
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION HAD NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    SURGEON ADVISED THAT HE HAS A PT IN WHICH THE 4.5 MM HEADLESS COMPRESSION SCREW HAS BROKEN POST-OPERATIVE. IT IS NOT KNOWN IF THE BROKEN SCREWS HAVE BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM HEADLESS COMPRESSION SCREW HEADLESS COMPRESSION SCREW HWC SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI