BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1810109 · Received August 17, 2010

    Report

    Report Number
    2520274-2010-00155
    Event Type
    Injury
    Date Received
    August 17, 2010
    Report Date
    July 19, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PART OR LOT NUMBER PROVIDED. CANNOT BE DETERMINED WITHOUT A PART OR LOT NUMBER. INVESTIGATION NOT COMPLETE, NO CONCLUSION CAN BE DRAWN. DEVICE HISTORY RECORD REVIEW CANNOT BE REQUESTED WITHOUT A PART AND LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED COMPLEX PROXIMAL FEMUR FRACTURE WITH A LARGE AREA OF COMMINUTION AND PROXIMAL FEMORAL PLATE WAS PLACED. PLATE BROKE WITHIN TWO MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI PROXIMAL FEMUR PLATE HRS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention