BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1920551 · Received December 7, 2010

    Report

    Report Number
    2520274-2010-00241
    Event Type
    Injury
    Date Received
    December 7, 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

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

    Description of Event or Problem · 1

    PT STATUS POST IMPLANTATION WITH PLATE AND SCREWS WAS IN PHYSICAL THERAPY AND HEARD A POP. PT RETURNED TO SURGEON AND AN X-RAY SHOWED ONE SCREW WAS BACKING OUT OF THE PLATE. PT FELL ONE MONTH LATER, RETURNED TO SURGEON; AN X-RAY SHOWED SEVEN SCREWS BACKED OUT OF THE PLATE. SURGEON IS SCHEDULING A REMOVAL OF THE HARDWARE. THIS IS SEVEN OF SEVEN 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 NI Required Intervention PLATE