BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2121330 · Received June 6, 2011

    Report

    Report Number
    2520274-2011-00182
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. UNABLE TO PROVIDE THE MFR, PMA/510K NUMBER AND/OR THE DATE OF 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 LOT NUMBER WAS PROVIDED. W/O A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PT STATUS POST PLATE AND SCREW IMPLANTATION HEARD A POPPING SOUND AND RETURNED TO SURGEON. AN X-RAY SHOWED THE PLATE AND TWO SCREWS WERE BROKEN. SURGEON REMOVED THE HARDWARE AND REPLACED WITH ANOTHER PLATE AND SCREWS. THE SHAFTS OF TWO SCREWS COULD NOT BE REMOVED AND REMAIN IN THE PT'S BONE. THIS IS TWO OF THREE REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention PLATE