BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3010374 · Received March 19, 2013

    Report

    Report Number
    1030489-2013-00774
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 17, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR SURGERY USING RHBMP-2/ACS AND A PEEK INTERBODY DEVICE. REPORTEDLY, SOME TYPE OF POLYMER AND BONE GRAFT WAS USED WITH RODS AND SCREWS. THE PATIENT REPORTEDLY UNDERWENT A SURGERY AT THE BOTTOM OF THE LUMBAR SPINE "THROUGH THE TAIL BONE" USING A BONE GRAFT MATERIAL WITH AN ARTIFICIAL DISC. REPORTEDLY, THE SURGEON "TORE UP" THE PATIENT, CAUSING A CSF LEAK AND "PUT A SCREW IN THROUGH MY NERVES." THE PATIENT WAS DISCHARGED 12 DAYS POST-OP. ON POD 16, THE PATIENT UNDERWENT SURGERY TO TREAT A CSF LEAK INCURRED DURING THE IMPLANT SURGERY. AT AN UNKNOWN TIME POST-OP, THE PATIENT HAS DEVELOPED A LOUD CONSTANT HUMMING WITH A HIGH FREQUENCY HEARD CONSTANTLY, HE REPORTS THIS GETS LOUDER AS HE CANNOT CHANGE THE FREQUENCY, ALTHOUGH HIS WIRELESS DEVICES IN HIS HOME DO INTERFERE WITH THE FREQUENCY. THE PATIENT REPORTED THAT A FRIEND HEARD THE NOISE WHEN HE GOT CLOSE TO HIS EAR; THE NOISE IS COMING OUT OF HIS EARS. REPORTEDLY, THE PATIENT IS NOT TAKING ANY PAIN MEDICATION, OR MIND ALTERING MEDICATIONS SUCH AS ANTIDEPRESSANTS OR ANTI-ANXIETY MEDICATIONS. REPORTEDLY, THE PATIENT'S SPINE IS BEING COMPRESSED, AND HIS NERVE ENDINGS ARE BEING COMPRESSED. THE PATIENT REPORTS THAT HE HAS "TINNITUS BECAUSE OF MY NERVES BEING DESTROYED." THE PATIENT REPORTS MEMORY PROBLEMS, AND STATES THAT HE IS IN "BAD SHAPE" AND THAT "WHATEVER IS INSIDE ME HAS BEEN HURTING ME." ADDITIONALLY, THE PATIENT REPORTED THAT "SOME KIND OF PASSIVE DEVICE INSIDE OF ME, I DON'T KNOW WHAT IT IS, BUT I'VE BEEN TOLD BY MANY HIGHWAY PATROL OFFICERS WITH THE RADAR GUNS THAT I SHOULDN'T BE DRIVING IMPAIRED BECAUSE "THEY'RE GETTING SOME KIND OF READING WHEN THEIR RADAR GUNS HIT ME." THE PATIENT HAS REPORTEDLY DEVELOPED PARALYSIS, NEUROLOGICAL PROBLEMS, ASPIRATION PROBLEMS, RESPIRATION PROBLEMS, NERVE DAMAGE, AND THE IMPLANT IS "HURTING" HIM. THE PATIENT REPORTED THAT THE IMPLANT GROWS AND SPREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114422 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention