BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER SPINE PRODUCT

    MDR report key: 2314458 · Received October 24, 2011

    Report

    Report Number
    9617544-2011-00354
    Event Type
    Injury
    Date Received
    October 24, 2011
    Report Date
    September 27, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVAL.

    Description of Event or Problem · 1

    MS. (B)(6), PATIENT, REPORTED IN HER EMAIL, THAT SHE WAS LAST YEAR IN THE HOSPITAL. THERE WERE A LOT OF SCREWS AND TWO TITAN RODS IMPLANTED (SPINE). THE SURGERY WAS 8 HOURS LONG. THIS YEAR, IN (B)(6), SHE PERFORMED SOME HOME-WORK. DURING THIS SHE FELT THAT ONE TITAN ROD WAS BROKEN. IN (B)(6) THIS YEAR SHE GOT A REVISION SURGERY. FURTHER INFO WILL BE ADDED AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STRYKER SPINE PRODUCT SPINE FIXATION ROD KWP STRYKER SPINE BORDEAUX UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R