BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1905812 · Received November 19, 2010

    Report

    Report Number
    1719045-2010-00345
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    November 3, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWQ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO PROVIDE THE PMA/510K AND THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AN NO PART/LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER A DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    SYNTHES WAS NOTIFIED THAT DURING A REVISION PROCEDURE THE SURGEON WAS REMOVING A PLATE AND THE PLATE BROKE NEAR THE TIP IN THE FEMORAL HEAD. SURGEON COULD NOT REMOVE THE PLATE AND THE TIP REMAINS IN THE PATIENT'S FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI ADOLESCENT OSTEOTOMY PLATES KWQ SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREW