BEUDAMED
    FDA Adverse Event Death Summary report: N

    VLIFT CAGE DIAM 22 X 37MM

    MDR report key: 1099664 · Received August 2, 2008

    Report

    Report Number
    9617544-2008-00072
    Event Type
    Death
    Date Received
    August 2, 2008
    Date of Event
    June 6, 2008
    Report Date
    July 15, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    K060506
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION AND PRODUCT HAS BEEN REQUESTED FOR EVALUATION, AND IF RECEIVED WILL BE SUPPLIED ON A SUPPLEMENTAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FDA LETTER RECEIVED AND SENT TO STRYKER SPINE 7/16/2008 THAT A MALE WAS ADMITTED APPROX ONE AND A HALF MONTHS EARLIER, STATUS POST CHEMOTHERAPY FOR THORACOTOMY AND VERTEBRECTOMY WITH A BLOC RESECTION AT T9, T10, T11 VERTEBRAE FOR HIGH GRADE SARCOMA. SURGERY 5/29/2008 WAS PERFORMED USING A SYNTHES PRODUCT AND THE NEXT DAY USING A STRYKER DEVICE. PATIENT DID WELL POST-OP AND WAS TRANSFERRED OUT OF ICU. TWELVE DAYS PRIOR TO ORIGIAL DATE, THE PATIENT WENT INTO CARDIAC ARREST AND CODED, AND WAS PRONOUNCED DEAD. PRELIMINARY AUTOPSY REPORT REVEALED THE VERTEBRAL CAGE TITANIUM PROSTHESIS WAS APPROPRIATELY POSITIONED WITH A PERIAORTIC/RETROPERITONEAL HEMATOMA WITH DISSECTION INTO RIGHT AND LEFT PLEURAL CAVITIES. 2400CC HEMOTHORAX RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VLIFT CAGE DIAM 22 X 37MM IMPLANT KWP STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death