BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1855129 · Received September 30, 2010

    Report

    Report Number
    2520274-2010-00171
    Event Type
    Injury
    Date Received
    September 30, 2010
    Report Date
    September 13, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO PROVIDE THE MANUFACTURER THE PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO PART/LOT INFORMATION PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS REC'D AND NO PART/LOT INFORMATION WAS PROVIDED. WITHOUT A LOT NUMBER, A DEVICE HISTORY RECORD REVIEW CANNOT BE REQUESTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF X-RAYS, IT WAS DISCOVERED PT'S STATUS POST PROXIMAL FEMORAL PLATE AND SCREWS WAS REVISED TO A DCS PLATE AND SCREWS. THE X-RAY SHOWS THE BARREL OF THE DCS IMPLANT GOING THROUGH THE TIP OF THE GREATER TROCHANTER WITH THE LAG SCREW POSITIONED IN THE CENTER OF THE FEMORAL HEAD AND ONE PARTIALLY 6.5 MM CANCELLOUS BONE SCREW AND ONE 4.5 MM CORTEX SCREW SUPPORTING THE NECK REGION. SURGEON REMOVED THE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI DCS PLATE HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREW