BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC IMPLANT

    MDR report key: 1920559 · Received December 8, 2010

    Report

    Report Number
    2530088-2010-00223
    Event Type
    Injury
    Date Received
    December 8, 2010
    Report Date
    November 11, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    K033868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MFG RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. MFR DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    SURGEON INDICATED THAT ONE OF HIS PTS THAT HAS BEEN IMPLANTED WITH A PT SPECIFIC IMPLANT HAS DEVELOPED POST-OPERATIVE HEMATOMA. WHEN THE IMPLANT WAS REMOVED THE HEMATOMA WENT AWAY, ONLY TO RETURN WHEN THE IMPLANT WAS PUT BACK IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT SPECIFIC IMPLANT PATIENT SPECIFIC IMPLANT GXN SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention