BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2103810 · Received May 18, 2011

    Report

    Report Number
    2520274-2011-00153
    Event Type
    Injury
    Date Received
    May 18, 2011
    Report Date
    May 2, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UNABLE TO PROVIDE THE MANUFACTURER, 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PATIENT STATUS POST CONSTRUCT IMPLANTATION ON AN UNKNOWN DATE, RETURNED TO SURGEON COMPLAINING OF PAIN. AN X-RAY WAS TAKEN AND SHOWED TWO HALOED (LOOSE) SCREWS. PATIENT WAS REVISED ON (B)(6) 2011 AND SURGEON DISCOVERED TWO LOOSE SCREWS IN L2 AND ONE BROKEN ROD ON THE RIGHT SIDE. SURGEON REMOVED ALL THE HARDWARE AND REPLACED THE CONSTRUCT ON THE RIGHT AS WELL AS THE LEFT FROM LEVELS S1 TO T11. OUT OF EIGHT SCREWS IT IS NOT KNOWN WHICH TWO SCREWS WERE LOOSE. THIS IS FOUR OF NINE REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention ROD