BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTREPID SPINAL SYSTEM

    MDR report key: 1217663 · Received October 29, 2008

    Report

    Report Number
    1030489-2008-00598
    Event Type
    Death
    Date Received
    October 29, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 29, 2008
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    K080083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, THE DEVICES IN USE ARE LOT # NX09; LOT #NV54. THE INTRAOPERATIVE X-RAYS REVIEW CONFIRMS THAT THE CONSTRUCT WAS IMPLANTED AT L4-L5 WITH SLIGHT RESIDUAL SPONDYLOLISTHESIS. IMPLANT WELL POSITIONED. POSTERIOR ELEMENTS HAVE BEEN REMOVED, CREATING A POTENTIALLY UNSTABLE SITUATION. LATER FILMS SHOW SPONDYLOLISTHESIS HAS PROGRESSED TO GRADE II- III. DEVICE SUBSIDED. SINGLE CANCELLOUS SCREW IN L4 WAS NOT ADEQUATE ALONE TO PREVENT PROGRESSIVE SPONDYLOLISTHESIS AND SUBSIDENCE IN THE PATIENT. ALTHOUGH IT WAS NOT BELIEVED THAT THE PRODUCTS CONTRIBUTED TO THE REPORTED DEATH, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ONE LEVEL SPINAL PROCEDURE AT L4/5 USING INTERBODY DEVICES. THE CONSTRUCT REPORTEDLY MIGRATED POST OP. THE REVISION SURGERY WAS PERFORMED FOUR WEEKS POST OP TO REPLACE THE DEVICES. WHILE RETRIEVING THE DEVICES, THE PATIENT'S VEIN WAS RETRACTED AND BLOOD CLOTS WERE FORMED. THE SURGERY PERFORMED A SEMI-POP BYPASS TO REPLACE THE VEIN. THE PATIENT HAD CARDIAC ARREST IN OR AFTER CLOSING. THE PATIENT WAS TRANSFERRED TO ICU AFTER HER CONDITION WAS STABILIZED. HOWEVER, THE PATIENT EXPIRED THREE DAYS LATER FROM RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTREPID SPINAL SYSTEM CAGE MAX SOFAMOR DANEK DEGGENDORF GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R