BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2862384 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02721
    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). A REVIEW OF IMAGING STUDIES FOUND AS FOLLOWS: (B)(6) 2009 MRI LUMBAR DESICCATION NOTED OF BOTH L4 AND L5 DISCS. LARGE LEFT PARACENTRAL HNP NOTED ON THE LEFT AT L5, DISPLACING S1 ROOT AND FLATTENING THE DURAL SAC. SMALL CENTRAL HNP IS ALSO NOTED AT L4 WITHOUT SIGNIFICANT STENOSIS. FLATTENED LUMBAR LORDOSIS IS NOTED IN THIS FILM AS WELL. (B)(6) 2010 CT LUMBAR SOLID FUSION IS AGAIN SEEN AT L4 AND L5 WITH ANTERIOR SPACERS/SCREWS AND PEDICLE SCREWS L4, L5 AND S1. DISC OSTEOPHYTE NOTED MIDLINE AT L5 WITH FACET ARTHROPATHY NOTED AT L4 AND L5 WITHOUT STENOSIS. MILD DEGENERATIVE CHANGES ARE NOW ALSO SEEN AT L3/4. (B)(6) 2010 MRI LUMBAR FUSION IS AGAIN NOTED AT L4 AND L5 ON SAGITTAL T2 VIEWS. SCREWS AT L4, L5 AND S1 ARE STABLE, WITH ANTERIOR CAGES WELL MAINTAINED NO DISC HERNIATION IS SEEN. DISC WITH OSTEOPHYTE IS AGAIN NOTED IN MIDLINE, WHICH DOES NOT SEEM TO AFFECT PASSING NERVE ROOTS. (B)(6) 2010 MRI LUMBAR LORDOSIS IS FLATTENED. DISC SPACES ARE WELL MAINTAINED EXCEPT FOR THE L4 AND L5 LEVELS WHICH HAVE BEEN INSTRUMENTED. ALIF HAS BEEN PERFORMED AT L4 AND L5 WITH PEEK SPACERS AND SCREWS. LYTIC AREA WITH CYST DENSITY PASSES INTO THE CANAL AT L5 BEHIND THE SPACER. THIS CONTINUES DOWN BEHIND THE S1 BODY, BUT WITHOUT NERVE COMPRESSION. L4 DISC SPACE HAS INCREASED SIGNAL AROUND THE IMPLANT ON THE LEFT SIDE. NO MASS EFFECT IS NOTED ON THE CANAL AT L4. PEDICLE SCREWS ARE PRESENT L4, L5 AND S1 BILATERALLY. BONE SEEMS TO BE IN CONTINUITY ACROSS BOTH DISC SPACES THROUGH THE SPACERS. (B)(6) 2009 CT LUMBAR STABLE FUSION IS AGAIN SEEN AT L4 AND L5. FACET CHANGES ARE NOTED AT L4 AND L5. ALSO NOTED ARE CENTRAL DISC OSTEOPHYTE COMPLEXES IN MIDLINE, WHICH DOES NOT APPEAR TO COMPRESS THE NEURAL ELEMENTS. (B)(6) 2009 MYELOGRAM LUMBAR AP AND LATERAL LUMBAR FILMS SHOW SEGMENTAL PEDICLE SCREWS L4-L5-S1 WITH ANTERIOR PEEK ALIF SPACERS IN GOOD POSITION HELD BY SCREWS. MYELOGRAPHY SHOWS NORMAL DURAL SAC CONTOUR ON AP WITHOUT EVIDENCE OF NARROWING. LATERAL MYELOGRAPHIC VIEW NOT PRESENT. (B)(6) 2009 MRI LUMBAR AGAIN SEEN IS A LARGE PARACENTRAL DISC HERNIATION LEFT L5 WITH DURAL SAC COMPRESSION AND S1 ROOT DISPLACEMENT ON THE LEFT. CENTRAL SMALL HNP IS ALSO NOTED AT L4. DESICCATION OF L4 AND L5 DISCS ARE SEEN ON SAGITTAL VIEWS. FLATTENED LORDOSIS IS ALSO NOTED IN LUMBAR AREA. (B)(6) 2011 MRI LUMBAR ANTERIOR INTERBODY DEVICES REMAIN IN PLACE. INTERVAL POSTERIOR DECOMPRESSION WITH REMOVAL OF PEDICLE SCREWS HAS BEEN PERFORMED AT L4 AND L5. POSTERIOR DISC OSTEOPHYTE COMPLEX REMAINS AT L5. LARGE METALLIC ARTIFACT IS NOTED ON THE RIGHT AT L5 IN THE AREA OF PREVIOUS PEDICLE SCREW/ROD INTERFACE. (B)(6) 2006 MRI LUMBAR PRESURGICAL EVALUATION SHOWING LARGEST YET LEFT PARACENTRAL HNP AT L5 AND CENTRAL HNP AT L4. SIGNIFICANT STENOSIS IS NOTED AT L5/S1 WITH MINIMAL COMPRESSION AT L4. DESICCATION OF L4 AND L5 DISCS IS SEEN ON T2 SAGITTAL VIEWS. (B)(6) 2008 MRI LUMBAR STILL NO INTERVENTION NOTED. LARGE SEQUESTERED FRAGMENT OF L5 DISC BEHIND S1 BODY CENTRAL AND LEFT PARACENTRAL WITH COMPRESSION OF CENTRAL DURAL SAC AND COMPRESSION OF THE LEFT S1 ROOT. SUBANNULAR PROTRUSION AT L4 WITH CENTRAL HYPERINTENSE ZONE NOTED AT L4, WITH LITTLE CHANGES SINCE FILM OF 2006. (B)(6) 2010 CT LUMBAR POST DISCOGRAM CT PERFORMED AFTER DISCOGRAM OF LUMBAR L1, L2 AND L3. DYE REMAINS WELL CENTERED WITHIN THE NUCLEUS AT EACH LEVEL WITHOUT EVIDENCE OF ANNULAR TEAR OR EXTRAVASATION. PROVOCATIVE PAIN RESPONSE IS NOT NOTED. A 360 FUSION WITH INSTRUMENTATION REMAINS UNCHANGED NOTED ON LATERAL REFERENCE FILM. CT AXIAL CUTS ARE NOT PERFORMED THROUGH PREVIOUSLY FUSED AREAS. THE DEVICE WAS NOT 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 PRESENTED WITH BACK AND LEG PAIN. THE PATIENT WAS DIAGNOSED WITH DEGENERATIVE DISCS AND HNP AT L4-5 AND L5-S1, LUMBAR RADICULOPATHY AND LUMBAR STENOSIS. THE PATIENT UNDERWENT L4-S1 ALIF FOLLOWED BY L4-S1 POSTERIOR SPINAL FUSION USING PEDICLE SCREW INSTRUMENTATION, ACTIFUSE, RHBMP-2/ACS, AND INTERBODY DEVICES. THE PATIENT WAS DISCHARGED ON POD 4. THERE WERE NO NOTED POST-OPERATIVE COMPLICATIONS. AT 66 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOWUP. X-RAYS OF THE LUMBAR SPINE INDICATED "NO ACTIVE PATHOLOGY IDENTIFIED." A CT SCAN OF THE LUMBAR SPINE INDICATED "STABLE APPEARING FUSION L4-L5 AND L5-S1 LEVEL. VERY MILD CENTRAL AND LEFT DISC OSTEOPHYTE COMPLEX PRESENTATION AT THE L4-L5 LEVEL. MILD BROAD BASED DISC PRESENTATION CENTRALLY L5-S1 LEVEL. NO TRUE DISC HERNIATION IS DEFINED." AT 183 DAYS POST-OP, A CT SCAN OF THE LUMBAR SPINE INDICATED "STABLE FUSION, L4-5 AND L5-S1 LEVELS." AT 196 DAYS POST-OP, AN MRI OF THE LUMBAR SPINE INDICATED "STABLE APPEARING FUSION L4-5 AND L5-S1 LEVEL." AT 270 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK AND LEFT LATERAL THIGH BURNING. AN EMG STUDY INDICATED "SUBTLE CHANGES SUSPICIOUS FOR A PRIOR LEFT S1 RADICULOPATHY WITH CHRONIC CHANGES. NO ACUTE DENERVATION NOTED. SUBTLE CHANGES CONSISTENT WITH A MILD LEFT LATERAL FEMORAL CUTANEOUS NEUROPATHY. LEFT SURAL SENSORY NEUROPATHY, MILD." AT 290 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK PAIN, BILATERAL THIGH PAIN, LEFT GREATER THAN RIGHT, AND PENILE AND BILATERAL FOOT NUMBNESS. AN MRI INDICATED "L4 TO S1 ANTERIOR AND POSTERIOR FUSION. T1-T2 HYPERINTENSE STRUCTURE, WITH PERHAPS MILD ENHANCEMENT , IN THE POSTERIOR INTERSPACE, MINIMAL PROTRUDING INTO THE VENTRAL EPIDURAL SPACE AT L4-5 AND MILDLY AT L5-S1. NO STENOSIS OF IMPINGEMENT ATE L4-5. AT L5-S1, THIS CONTACTS BUT DOES NOT DISPLACE OR IMPINGE THE S1 NERVE ROOTS. THIS MAY REPRESENT A SMALL AMOUNT OF DISK OSTEOPHYTE OR OSSIFIED GRAFT POSTERIOR TO THE INTERBODY CAGE." MILD FACET ARTHROPATHY AT L2-3 AND L3-4 WITHOUT STENOSIS." AT 239 DAYS POST-OP, THE PATIENT PRESENTED WITH BACK PAIN. PER THE PHYSICIAN'S NOTES, "PATIENT COMPLAINS OF LUMBAR REGION PAIN. THE DIS COMFORT IS MOST PROMINENT IN THE MID AND LOWER LUMBAR SPINE. THIS RADIATES TO THE LEFT ANTERIOR THIGH. HE CHARACTERIZES IT AS CONSTANT, MODERATE IN INTENSITY, AND SHARP. THIS IS A CHRONIC, BUT INTERMITTENT PROBLEM WITH AN ACUTE EXACERBATION. HE STATES THAT THE CUR RENT EPISODE OF PAIN STARTED 4 DAYS AGO. THE EVENT WHICH PRECIPITATED THIS PAIN WAS A FALL WALKING IN HOME" ASSOCIATED SYMPTOMS INCLUDE WEAKNESS OF THE LEFT LOWER LEG." AT 312 DAYS POST-OP, THE PATIENT PRESENTED WITH LEFT MERALGIA PARESTHETICA AND COMPRESSION OF THE LEFT LATERAL FEMORAL CUTANEOUS NERVE. THE PATIENT UNDERWENT A LEFT NEUROLYSIS OF THE LATERAL FEMORAL CUTANEOUS NERVE REPRESENTING A DECOMPRESSION OF A MAJOR PERIPHERAL NERVE FROM THE LUMBAR PLEXUS. THERE WERE NO NOTED COMPLICATIONS. AT 403 DAYS POST-OP, THE PATIENT PRESENTED WITH LOWER BACK PAIN WITH LEFT LEG RADICULOPATHY. PER THE PHYSICIAN'S NOTES, THE PATIENT "ON (B)(6), 2010" HAD A LEFT LATERAL FEMORAL CUTANEOUS NERVE DECOMPRESSION, AND SINCE THEN, HIS LEFT THIGH HAS BEEN NUMB. "HE CONTINUES TO HAVE LOWER BACK PAIN WITH LEFT LEG PAIN. HE STATES HIS PAIN IN HIS BACK RADIATES DOWN TO HIS LEFT BUTTOCK TO THE POSTERIOR LATERAL HAMSTRING TO THE POSTERIOR TIBIALIS ALL THE WAY DOWN TO HIS FOOT. HE ALSO HAS NUMBNESS AND TINGLING IN HIS WHOLE LEG DOWN TO HIS FOOT. HIS PAIN IN HIS BACK AND LEG, HE DESCRIBES AS A BURNING, SHARP, SHOOTING, SEVERE IN NATURE PAIN" HE ALSO STATES THAT HIS LEFT CALF CRAMPS A LOT." AT 442 DAYS POST-OP, THE PATIENT UNDERWENT A REVISION SURGERY TO TREAT POSTLAMINECTOMY SYNDROME WITH POSSIBLE PSEUDOARTHROSIS. AT 539 DAYS POST-OP, THE PHYSICIAN'S NOTES INDICATE THAT THE PATIENT "HAS A NINE YEAR HISTORY OF CHRONIC PAIN." THE PATIENT TELLS ME THAT HE UNDERWENT SURGERY IN [IMPLANT DATE]. HE TELLS ME THE SURGEON WHO PERFORMED THE PROCEDURE "SEVERED MY FEMORAL NERVE." THE PATIENT STATES HE HAS UNDERGONE LUMBAR EPIDURAL STEROID INJECTIONS IN THE PAST WHICH WERE NOT EFFECTIVE" THE PATIENT STATES HE IS BETTER SINCE SURGERY, BUT STILL COMPLAINS OF CHRONIC PAIN." AT 557 DAYS POST-OP, THE PATIENT UNDERWENT A MEDIAL BRANCH BLOCKAGE OF THE L3 AND L4 MEDIAL BRANCH NERVES BILATERALLY AND THE L5 DORSAL RAMUS NERVE BILATERALLY. THERE WERE NO NOTED COMPLICATIONS. AT 694 DAYS POST-OP, AN MRI OF THE LUMBAR SPINE INDICATED "ENHANCING SCAR AND A FLUID COLLECTION SEEN POSTERIOR TO THE FORMER LOCATION OF THE LAMINA. THE FLUID COLLECTION IS NOT COMMUNICATING WITH THE THECAL SAC. IT MAY ARISE FROM THE FORMER FACET JOINT REGION ON THE LEFT. AT L4-5 LEFT LATERAL RECESS AND LEFT NEURAL FORAMEN ARE FILLED WITH ENHANCING MATERIAL MOST CONSISTENT WITH SCAR. THE LEFT L4 NERVE ROOT GANGLION IS SURROUNDED BY SCAR AND MAY BE MILDLY COMPRESSED THIS MAY BE A SOURCE OF THE PATIENT'S SYMPTOMS." AT 701 DAYS POST-OP, THE PATIENT PRESENTED WITH FAILED BACK SURGERY SYNDROME, CHRONIC LOW BACK PAIN, AND RESIDUAL CHRONIC LEG PAIN. THE PATIENT UNDERWENT IMPLANTATION OF A BOSTON SCIENTIFIC SPINAL CORD STIMULATOR WITH A PADDLE ELECTRODE. THERE WERE NO NOTED COMPLICATIONS. AT 738 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOWUP. THE PATIENT REPORTED LOW BACK PAIN, BILATERAL LEG PAIN AND INSOMNIA. THE PATIENT'S SPINAL CORD STIMULATOR WAS REPROGRAMMED. AT 771 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK PAIN, BILATERAL LEG PAIN, INSOMNIA, AND NAUSEA AND VOMITING. THE PATIENT HAD HIS SPINAL CORD STIMULATOR REPROGRAMMED. AT 889 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK PAIN AND BILATERAL LEG PAIN. PER THE PHYSICIAN'S NOTES, THE PATIENT "IS USING HIS SPINAL CORD STIMULATOR PRETTY MUCH AROUND THE CLOCK" HE HAS BEEN DIAGNOSED WITH PLANTAR FASCIITIS" THE PATIENT UNDERWENT A SLEEP STUDY" WHICH CONFIRMED OBSTRUCTIVE SLEEP APNEA. THE PATIENT WAS TRIALED ON CPAP BUT HE COULD NOT TOLERATE IT. HE IS NOW ON SUPPLEMENTAL OXYGEN AT NIGHT."

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention