BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5024292 · Received August 24, 2015

    Report

    Report Number
    1030489-2015-02050
    Event Type
    Injury
    Date Received
    August 24, 2015
    Report Date
    July 27, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER, THEREFORE, CAUSE OF EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2011: THE PATIENT PRESENTED WITH COMPLAINT OF LOW BACK PAIN. ON (B)(6) 2011: THE PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2011: THE PATIENT PRESENTED FOR PRE-OP DIAGNOSIS. ON (B)(6) 2011: THE PATIENT PRESENTED FOR PREOPERATIVE MEDICAL CLEARANCE. IMPRESSION: NEGATIVE EXAMINATION OF THE CHEST. HE WAS ALSO DIAGNOSED WITH RIGID LUMBOSACRAL ORTHOSIS. ON (B)(6) 2011: THE PATIENT PRESENTED WITH ADMITTING DIAGNOSES OF: 1. LUMBAR DISC DEGENERATIVE DISEASE. 2. LUMBAR FACET ARTHROPATHY. 3. LUMBAR HERNIATED NUCLEUS PULPOSUS, FAR LATERAL. 4. LUMBAR RADICULOPATHY. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. ANTERIOR LUMBAR INTERBODY FUSION, L4-L5, L5-S1. 2. ANTERIOR LUMBAR INSTRUMENTED FUSION, L4-L5, L5-S1. 3. POSTERIOR LUMBAR SEGMENTAL INSTRUMENTED FUSION, L4-L5, L5-S1. 4. POSTEROLATERAL ARTHRODESIS, L4-L5, L5-S1. 5. MICRODECOMPRESSION OF THE FAR LATERAL HERNIATION AT L4-L5 ON THE LEFT SIDE. PER-OP NOTES, THE PATIENT NATIVELY IN THE SUPINE POSITION, MEASURED APPROXIMATELY 13 MM ACROSS. THE SURGEON WAS ABLE TO PUT A 15 MM INTERBODY GRAFT TO FACILITATE INDIRECT FORAMINAL DECOMPRESSION WITH THE ELEVATED GRAFT. IN ADDITION, THE GRAFT HAD GOOD FIT AND FILL. A 15 MM SPINE USA INTERBODY GRAFT WAS THEN IMPREGNATED WITH RHBMP-2/ACS, A LARGE KIT WAS OPENED ON THE BACK TABLE. THIS WAS AUGMENTED WITH SOME OSTEOBIOLOGICAL BONE EXTENDERS AND THE L5-S1 INTERBODY FUSION CAGE WAS THEN IMPACTED INTO THE L5-S1 SEGMENT. THESE EXACT SAME STEPS WERE THEN REPEATED TO PERFORM THE SAME INTERBODY FUSION CAGE AT THE L4-L5 SEGMENT. ALLOSOURCE ALLOSTEMS, PEEK CAGE, ANTERIOR BUTTRESS PLATE, CANCELLOUS SCREW, K-WIRES, CANNULATED SCREWS, SCREW CAP, PEDICLE SCREWS AND SET SCREWS WERE USED. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2011: THE PATIENT WAS DISCHARGED. HE HAD INSTRUCTIONS NOT TO LIFT GREATER THAN 15 POUNDS OR BEND BEYOND 45 DEGREES. ON (B)(6) 2011: THE PATIENT PRESENTED 2 WEEKS, POST-OP DUE TO LUMBAR DISC DEGENERATIVE DISEASE. ON (B)(6) 2011: THE PATIENT PRESENTED FOR A POST-OP RECHECK. IMPRESSION: THERE WAS NO SIGNIFICANT INTERVAL CHANGE WHEN COMPARED TO PRIOR STUDY. ON (B)(6) 2011: THE PATIENT PRESENTED WITH PROBLEMS OF PAIN, LOSS OF MOTION, WEAKNESS, FLEXIBILITY AND GAIT. IMPRESSION: THESE SIGNS AND SYMPTOMS WERE CONSISTENT WITH STATUS POST L4-L5 AND L5-S1 FUSION. ON (B)(6) 2011: THE PATIENT PRESENTED WITH CHIEF COMPLAINTS OF STOMACH AND BACK PAIN. HE HAD PAIN IN LEGS, HIPS AND BUTTOCKS. HE FELT SHARP AND RADIATING PAIN WHICH WOULD GET WORSE AT NIGHT, IN THE MORNING AND WITH ACTIVITY. HE FELT SLEEPY AND LETHARGIC DURING THE DAY. HE UNDERWENT X-RAY OF LUMBAR SPINE. IMPRESSION: NO COMPRESSION FRACTURE OR SUBLUXATION NOTED IN LUMBAR SPINE. ON (B)(6) 2011: THE PATIENT UNDERWENT AN MRI OF LUMBAR SPINE W/WO CONTRAST. IMPRESSION: THE LEFT NEURAL FORAMEN APPEARS MILD-MODERATELY NARROWED DUE TO ENDPLATE SPURRING <(>&<)> FACET HYPERTROPHY. THIS COULD POTENTIALLY IMPINGE UPON THE EXITING LEFT L4 NERVE ROOT. L5-S1: FACET JOINTS ARE MILDLY HYPERTROPHIED. ON (B)(6) 2011: THE PATIENT PRESENTED WITH REVIEW OF MRI FILMS. ASSESSMENT: 1. FAILED BACK SYNDROME 2. LOW BACK PAIN 3. LUMBAR RADICULITIS. ON (B)(6) 2012: THE PATIENT UNDERWENT AN MRI OF LUMBAR SPINE W/WO CONTRAST. IMPRESSION: LEFT FORAMINAL OSTEOPHYTES CAUSE MILD LEFT FORAMINAL STENOSIS OF THE LEFT L4-L5 FORAMEN. ON (B)(6) 2012: THE PATIENT PRESENTED WITH LUMBAR SPINE PAIN. ASSESSMENT: 1. BACK PAIN 2. POSTOP LUMBAR LAMINECTOMY PAIN. ON (B)(6) 2012, THE PATIENT UNDERWENT A CT OF LUMBAR SPINE WITHOUT CONTRAST DUE TO LOW BACK PAIN WITH BILATERAL LEG PAIN FOR THREE WEEKS. IMPRESSION: THERE IS ASYMMETRIC ENDPLATE SPURRING PROJECTED INTO THE LEFT L4-L5 NEURAL FORAMEN WITH MILD FORAMINAL STENOSIS. ON (B)(6) 2013: THE PATIENT UNDERWENT X-RAY OF CHEST WITH PA AND LATERAL VIEWS. IMPRESSION: NO ACUTE CARDIOPULMONARY DISEASE. ON (B)(6) 2013: THE PATIENT PRESENTED WITH FOLLOWING PREOPERATIVE DIAGNOSIS: PRIOR LUMBAR FUSION WITH INSTRUMENTATION. THE PROCEDURES PERFORMED WERE: 1. REMOVAL OF HARDWARE 2. EXPLORATION OF FUSION. THE PATIENT ALSO CONSULTED FOR MANAGEMENT OF POSTOP MEDICAL PROBLEMS. IMPRESSION: 1. POSTOPERATIVE LAMINECTOMY PAIN IN THE LUMBAR AREA. 2. PAIN IN THE BACK 3. ABNORMAL ELECTROCARDIOGRAM. 4. HISTORY OF SMOKING IN THE PAST. ON (B)(6) 2013: THE PATIENT PRESENTED 2 WEEKS POST-OP, REMOVAL OF HIS LUMBAR HARDWARE. ASSESSMENT: 1. POSTLAMINECTOMY SYNDROME OF LUMBAR REGION 2. FAILED BACK SYNDROME. ON (B)(6) 2013: THE PATIENT PRESENTED POST-OP, LUMBAR SPINE SURGERY. ASSESSMENT: 1. BACK PAIN 2. POSTOP LUMBAR LAMINECTOMY PAIN 3. LUMBAR SPONDYLOSIS. ON (B)(6) 2013: THE PATIENT PRESENTED POST-OP, LUMBAR SPINE SURGERY. ON (B)(6) 2013: THE PATIENT PRESENTED FOR AN OFFICE VISIT. LOCATION OF PAIN WAS MID THORACIC. PAIN HAS RADIATED TO THE DERMATOME ANTERIORLY. THE PATIENT DESCRIBED THE PAIN AS SHARP AND STABBING WHEN BENDING FORWARD. THE SYMPTOMS WERE AGGRAVATED BY TWISTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558124 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110919AAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other