BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3422760 · Received October 22, 2013

    Report

    Report Number
    1030489-2013-04253
    Event Type
    Injury
    Date Received
    October 22, 2013
    Report Date
    September 24, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 ON (B)(6) 2008 THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION, POSTERIOR SPINAL FUSION AND DECOMPRESSION, L5-S1, BMP SPONGE (1/2 OF SMALL BMP SPONGE PLACED INTO INTERVERTEBRAL SPACE). ON (B)(6) 2008 ,PT ON LONG-TERM DISABILITY SINCE (B)(6) 2006. ON (B)(6) 2008 PT C/O INCISIONAL PAIN (B)(6) 2008 3 ½ WEEKS POST TLIF/DECOMPRESSION L5-S1, SHARP PRE-OP LBP HAS RESOLVED AND IS SLOWLY IMPROVING; HISTORY OF HERNIA SURGERY HAVING SOME TESTICULAR PAIN. ON (B)(6) 2008, LBP RADIATING TO LLE; LUMBOSACRAL NEURITIS. ON (B)(6) 2008 PT REPORTS THAT DR (B)(6) HAS CONSIDERATIONS FOR POSSIBLE REMOVAL OF HARDWARE. ON (B)(6) 2008, CONTINUED TO HAVE LBP, LEFT LEG PAIN AND WEAKNESS SINCE LAST VISIT; BACK PAIN WITH RADIATION, LUMBAR DEGENERATION, ACQUIRED SPONDYLOLISTHESIS. ON (B)(6) 2008, CT OF LUMBAR SPINE-5 MONTHS STATUS POST L5-S1 FUSION WITH PERSISTENT LOWER BACK PAIN, LEFT LEG PAIN AND LEFT LEG WEAKNESS-SHOWS OSSEOUS FUSION ACROSS PORTIONS OF THE L5-S1, POSTERIOR METALLIC FUSION APPARATUS IS INTACT AND UNREMARKABLE IN APPEARANCE. THERE DOES NOT APPEAR TO BE OSSEOUS FUSION ON EITHER SIDE POSTEROLATERALLY, BROAD SHALLOW POSTERIOR OSTEOPHYTES AT THE L5-S1 LEVEL WITH BILATERAL OSTEOPHYTES, SECONDARY UP-DOWN L5-S1 FORAMINAL STENOSIS, MILD MULTILEVEL ANTERIOR DEGENERATIVE SPONDYLOSIS. XRAY LUMBAR SPINE SHOWS EDEMA WITHIN THE PARASPINAL MUSCULATURE AND A SMALL HEMATOMA WITHIN THE LEFT PARASPINAL MUSCLES. ON (B)(6) 2008, LUMBAR/LUMBOSACRAL DISC DEGENERATION, ACQUIRED SPONDYLOLISTHESIS, PARASPINAL EDEMA MAY CONTRIBUTE TO LBP. ON (B)(6) 2008, PANIC DISORDER, MIGRAINES; NOTED HE SMOKES ½ PACK PER DAY SINCE AGE 13. ON (B)(6) 2008, CONTINUES TO HAVE LBP AND LEG RADICULOPATHY, POST OP IMAGES, NO SIGNS OF CONTINUED NERVE COMPRESSION. ON (B)(6) 2008, BILATERAL LUMBAR PAIN, RADIATING TO THE LEFT BUTTOCK, LEFT POSTERIOR THIGH, LEFT LATERAL CALF AND LEFT MEDIAL CALF, SHARP, CHRONIC, CONSTANT STABBING PAIN. ON (B)(6) 2009, LEFT PARASCAPULAR MUSCLE STRAIN AND CHEST WALL PAIN, PT RECOMMENDED (B)(6) 2009 1 YR S/P L5-S1 TLIF DECOMPRESSION AND 2 YEARS S/P C5-7 ACDF, CONTINUED LBP SINCE SURGERY, MAINLY PARASPINAL, IMPROVED RADICULOPATHY, OCCASIONAL LEFT SIDED RADICULOPATHY INTO HIS ARM; POST LAMINECTOMY SYNDROME. ON (B)(6) 2009, TO SEE DR (B)(6) WITH CONTINUED NECK/BACK PAIN AND POLYARTHRALGIA, PAIN MEDS WITH MODERATE IMPROVEMENT, RECENTLY DIAGNOSED WITH RHEUMATOID ARTHRITIS, ALSO C/O HEADACHE, NAUSEA AND VOMITING, SOLID STABILITY AND FUSION IN HIS NECK AND BACK, POLYARTHRALGIA AND EXTREMITY PAIN THAT CAN¿T BE ACCOUNTED FOR BY HIS NECK AND BACK, CONTINUE PT, EXERCISES, PAIN MEDS PRN, AND SEE RHEUMATOLOGIST. ON (B)(6) 2009, MULTILEVEL DEGENERATIVE DISC DISEASE AND MILD FACET JOINT ARTHROPATHY SUPERIOR AND INFERIOR TO THE FUSION. ON (B)(6) 2010, WORSENING OF BACK PAIN ISSUES WITH WEATHER CHANGES (B)(6) 2010 C/O BILATERAL CERVICAL SPINE PAIN, NOTES THAT APPROXIMATELY ONE MONTH AGO, WHILE GETTING HAIR WASHED, THE SCRUB SINK SUDDENLY GAVE WAY CAUSING HIS NECK TO JOLT BACKWARDS STRIKING THE BOTTOM OF HIS NECK HARD UPON THE SINK EDGE, SINCE THEN HAS HAD PROGRESSIVE NECK PAIN; STARTED ANTI-DEPRESSANTS AND HERBAL MEDS WITH WORSENING OF HIS SYMPTOMS, RECOMMENDED SEEING PHYSIATRIST FOR TRIGGER POINT INJECTION AND CONSULT NEUROLOGIST. ON (B)(6) 2010, DR (B)(6) SUCCESSFUL FUSED SINCE L-SPINE SURGERY BUT HAS CONTINUED LOW BACK PAIN. HIS NECK APPEARS TO HAVE UNDERGONE A PSEUDOARTHROSIS BECAUSE OF LIKELY HIS CONTINUED SMOKING AFTER SURGERY, STILL HAS NECK PAIN BUT IMPROVEMENT IN HIS RADICULOPATHY; DIAGNOSED WITH FIBROMYALGIA SINCE LAST VISIT, VALIUM, PERCOCET, LYRICA, KEFLEX, AMBIEN, ROBAXIN; POSTLAMINECTOMY SYNDROME,-CERVICAL; HAS REACHED MMI IN HIS L-SPINE GIVEN NO POSSIBLE INTERVENTION SURGICALLY THAT DR (B)(6) WOULD RECOMMEND. HE DOES HAVE NECK PAIN THAT A PSEUDO COULD BE A CANDIDATE FOR A PSF IN HIS NECK. HOWEVER, GIVEN HIS FIBROMYALGIA AND HAVING TO INTERVENE THROUGH HIS POSTERIOR MUSCULATURE IN HIS NECK, DR (B)(6) RECOMMENDS PSYCH CARE AND CARE FOR PT¿S FIBROMYALGIA. ON (B)(6) 2010, RECOMMENDED TO SEE PHYSIATRIST FOR TRIGGER POINT INJECTION. ON (B)(6) 2010, NEURO CONSULT-PANIC DISORDER, ANXIETY DISORDER MIGRAINES. ON (B)(6) 2011 CONTINUED BACK AND NECK PAIN. ON (B)(6) 2011, PT STATES HE HAS BEEN HAVING ¿OUT OF BODY¿ EXPERIENCES. ON (B)(6) 2011, RECOMMENDED FOLLOW UP WITH PAIN MANAGEMENT, EXERCISES, AND THERAPY. MENTIONED THE POSSIBILITY OF HARDWARE REMOVAL AND POSTERIOR SPINAL FUSION IN HIS NECK, PT DOES NOT WANT OPERATIVE INTERVENTION. ON (B)(6) 2011, WEARING LUMBAR BRACE PRN; LBP RADIATING TO LEFT BUTTOCK AND LLE. ON (B)(6) 2012, NECK PAIN (B)(6) 2011 REQUIRES ASSISTANCE WITH ADLS (ACTIVITIES OF DAILY LIVING). ON (B)(6) 2011, MRI LUMBAR SPINE-BROAD BASED OSTEOPHYTIC RIDGE THAT COMPRESSES THE VENTRAL SURFACE OF THE THECAL SAC AND CAUSES BILATERAL MODERATE NEURAL FORAMINAL STENOSIS AND CROWDING OF L5 NERVE ROOTS, CONCORDANT WITH BLE PARESTHESIAS. ON (B)(6) 2012, INCREASED LOW BACK PAIN RADIATES TO THIGHS BILATERALLY, PT REMAINS COMPLETELY DISABLED AND COMPETITIVELY UNEMPLOYABLE. ON (B)(6) 2012, PERMANENTLY DISABLED. ON (B)(6) 2013, NECK PAIN, LOW BACK PAIN AND LEG PAIN, NOTES SHORT-TERM MEMORY PROBLEMS, BILATERAL MYOFASCIAL TENDERNESS-CAUSING HEADACHES, PT, CHONDROMALACIA PATELLAE RIGHT KNEE, PT STATES DR (B)(6) IS CONSIDERING POSSIBLE REMOVAL OF HARDWARE, POSITIVE RA PANEL. ON (B)(6) 2013, CHRONIC CBP, CONSIDERING REMOVAL OF HARDWARE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540280 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110704AAC

    Patients

    Seq Age Sex Outcome Treatment
    1