BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2862529 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02714
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    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 L4 AND L5 BILATERAL LAMINECTOMIES, FACETECTOMIES AND FORAMINOTOMIES, AND PLIF USING RHBMP- 2/ACS, X-BONE INOVASIS PEEK INTERBODY CAGES, AND INOVASIS POSTERIOR INSTRUMENTATION. THERE WERE NO NOTED COMPLICATIONS. ONE DAY POST-OP, X-RAYS OF THE LUMBAR SPINE INDICATED "STATUS POST DISCECTOMY AND FUSION AT L4-L5 WITH EXPECTED POSTOPERATIVE CHANGES. DISTENDED FLUID AND GAS-FILLED RECTUM." AT 16 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "THE PATIENT HAS NO PAIN OR DISCOMFORT. PARESTHESIAS ARE DIMINISHED. STRENGTH HAS IMPROVED. SENSATION HAS IMPROVED." AT 33 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "HE STATES THAT HE IS DOING QUITE WELL. HE HAS NO SEVERE PAIN. HE RECENTLY DEVELOPED A RESPIRATORY INFECTION WITH BRONCHITIS, HE HAD QUITE A BIT OF COUGHING, THIS STIMULATED SOME PAIN IN HIS LOWER BACK." AT 54 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "THE SYMPTOMS THAT HE WAS HAVING BEFORE SURGERY, THAT IS THE SEVERE LOW BACK, BUTTOCK, AND LEG PAIN, WITH SHOOTING PAIN IN HIS LEGS AND PARESTHESIAS, IS GONE." AT 82 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. THERE WERE NO NOTED COMPLICATIONS. AP AND LATERAL VIEWS OF THE SPINE INDICATED "NO SIGNIFICANT INTERVAL CHANGE. STABLE POSTOPERATIVE CHANGES AT L4-L5." AT 110 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "HE NOW COMPLAINS OF "BAD BACK PAIN." HE STATES THAT HE BACK FEELS "LIKE THERE IS A BRICK OR 2X4 IN IT." OVERALL THOUGH, HIS PAIN MUST BE BETTER BECAUSE HE IS NOW ONLY TAKING 2 PERCOCETS A DAY. HE HAS NO NEW SYMPTOMS." AT 138 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "HE FEELS THAT HE HAS VERY LITTLE STRENGTH. HE HAS NO LEG PAIN, BUT DOES HAVE BACK PAIN. HIS BACK BECOMES QUITE STIFF AND GOES INTO SPASM. HE STATES THAT IT STILL TAKES A LOT OF EFFORT FOR HIM TO GET IN AND OUT OF A CHAIR." AT 229 DAYS POST-OP, THE PATIENT PRESENTED FOR AN OFFICE VISIT. PER THE PHYSICIAN'S NOTES, "UNFORTUNATELY HE CONTINUES TO HAVE SEVERE LOW BACK PAIN. IT IS CONSTANT" PHYSICAL THERAPY IS NOT HELPING. HE HAS NO NEW NEUROLOGIC SYMPTOMS." AT 285 DAYS POST-OP AN MRI OF THE LUMBAR SPINE INDICATED "POST OPERATIVE CHANGE AT L4-L5, WITH EXTENSIVE SCAR SEEN IN THE SPINAL CANAL AS WELL AS IN THE POSTERIOR SOFT TISSUES AT THAT LEVEL. NO DISC HERNIATION IS IDENTIFIED." AT 519 DAYS POST-OP, THE PATIENT PRESENTED FOR NEUROLOGICAL CONSULTATION. PER THE PHYSICIAN'S NOTES, "THE PATIENT WILL BE SENT FOR EMG AND NERVE CONDUCTION STUDIES TO BILATERAL LOWER EXTREMITIES TO CHECK FOR ACUTE VERSUS CHRONIC RADICULOPATHY." X-RAY IMAGING STUDIES INDICATED "POSTOPERATIVE CHANGES AT L4 AND L5 WITH INTER-PEDICULAR SCREWS AND POSTERIOR STABILIZATION RODS WITH BONE GRAFT MATERIAL SEEN POSTERIORLY. NO ACUTE COMPLICATING PROCESS IS SEEN." AT 596 DAYS POST-OP, A CT SCAN OF THE LUMBAR SPINE INDICATED "SATISFACTORY POSTOPERATIVE APPEARANCE AT THE L4-L5 LEVEL WITH NORMAL ALIGNMENT AND POSITIONING. THERE IS SOME METALLIC ARTIFACT OBSCURING THIS REGION. OTHERWISE, NORMAL STUDY. NO EVIDENCE OF SPONDYLOLISTHESIS." A MOTOR NERVE CONDUCTION STUDY INDICATED "EVIDENCE OF MILD CHRONIC CHANGE AT RIGHT L5-S1. OTHERWISE, THERE IS NO ACUTE OR CHRONIC DENERVATION. THERE IS NO EVIDENCE OF LARGE FIBER NEUROPATHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110803AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention