BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1921582 · Received December 6, 2010

    Report

    Report Number
    2520274-2010-00232
    Event Type
    Injury
    Date Received
    December 6, 2010
    Report Date
    November 11, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO PROVIDE THE MANUFACTURER, PMA/510K NUMBER AND OR THE DATE OF THE MANUFACTURE AS NO PRODUCT WAS RETURNED AND 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

    PATIENT STATUS POST PROXIMAL HUMERUS PLATE AND PROXIMAL LOCKING SCREWS IMPLANTATION EXPERIENCED A FALL. PATIENT RETURNED TO SURGEON AND AN X-RAY SHOWED FIVE PROXIMAL LOCKING SCREWS HAVE BACKED OUT OF THE PLATE, THE SCREWS DID NOT GO THROUGH THE PLATE. SURGEON EXPLANTED THE HARDWARE AND REVISED THE PATIENT TO EPOCA SYSTEM. THIS IS THREE OF SIX REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention PLATE