BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3413185 · Received October 16, 2013

    Report

    Report Number
    1030489-2013-04185
    Event Type
    Injury
    Date Received
    October 16, 2013
    Report Date
    September 17, 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 THE PATIENT PRESENTED WITH SIGNIFICANT HISTORY OF INTRACTABLE NECK PAIN AND RADICULOPATHY FROM A MOTOR VEHICLE ACCIDENT. THE PATIENT HAD INTRACTABLE PAIN AND FAILURE OF NON-OPERATIVE CARE. ON (B)(6) 2009, AN EMG AND NCV REVEALED MODERATE RIGHT MEDIAN NEUROPATHY (SENSORY DEMYELINATING AND AXONAL), MILD LEFT MEDIAN NEUROPATHY AT THE WRIST (SENSORY DEMYELINATING ONLY), AND NO ELECTRODIAGNOSTIC EVIDENCE OF THE RIGHT OR LEFT CERVICAL RADICULOPATHY. ON (B)(6) 2009, THE PATIENT UNDERWENT A C5-C6 POSTERIOR CERVICAL EXPLORATION AND DECOMPRESSION, BILATERAL C5 LATERAL MASS SCREW PLACEMENT USING OASIS SYSTEM, BILATERAL C6 LATERAL MASS SCREW PLACEMENT USING OASIS SYSTEM. C5-C5 SPINOUS PROCESS WIRING USING ATLAS CABLE, AND C5-C6 POSTERIOR CERVICAL FUSION USING AUTOLOGOUS AND ALLOGRAFT BONE. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2010, THE PATIENT UNDERWENT A RIGHT ENDOSCOPIC CARPAL TUNNEL RELEASE. ON (B)(6) 2010, THE PATIENT UNDERWENT A LEFT OPEN CARPAL TUNNEL RELEASE. ON (B)(6) 2011, THE PATIENT PRESENTED WITH COMPLAINTS OF ACHING IN HER ARMS, HAND SWELLING, OCCASIONAL HAND TINGLING, OCCASIONAL NECK PAIN, AND NUMBNESS IN ALL THE FINGERS WHEN SLEEPING IN THE WRONG POSITION. TREATMENT INCLUDED EMG AND NCV, AND TRIAL OF CARPAL TUNNEL SPLINTING OR HAND OCCUPATIONAL THERAPY. EMG AND NCV REVEALED EVIDENCE FOR MILD LEFT CARPAL TUNNEL SYNDROME AND BORDERLINE TO MILD RIGHT CARPAL TUNNEL SYNDROME. ON (B)(6) 2011, CERVICAL SPINE X-RAY WITH FLEXION, EXTENSION AND LATERAL VIEWS REVEALED ¿POSTSURGICAL CHANGES NOTED, THERE ARE SOME MINIMAL MOVEMENT ON THE FLEXION AND EXTENSION VIEWS SEEN BETWEEN C2 AND C3 (THIS IS A MINIMAL FINDING), AND OVERALL EXAM APPEARS STABLE AS COMPARED TO OUR (B)(6) 2010 EXAM¿. ON (B)(6) 2011, CT SCAN REVEALED ¿C2-C3, C3-C4, AND C4-C5 MILD DIFFUSE DISC BULGE, SMALL RIGHT PARACENTRAL DISC HERNIATION OR PROTRUSION OF THE C5-C6 DISC, POSTERIOR FUSION OF C5-C6 INTERSPACE IS NOTED¿.THERE IS NO EVIDENCE OF ANY HARDWARE FAILURE, AND THESE APPEAR TO BE SOLIDLY FUSED POSTERIORLY¿.FACET JOINTS OF C6 AND C7 ALSO APPEAR TO BE FUSED¿. ON (B)(6) 2011, THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND COMPLAINED OF ARM PAIN, PARESTHESIA, AND NUMBNESS AND NECK PAIN. ON (B)(6) 2011, CERVICAL SPINE REVEALED ¿SLIGHT CERVICAL KYPHOSIS AT THE LEVEL OF SURGICAL FUSION AT C5-C6 WITH ASSOCIATED FINDINGS AS ABOVE¿THE SURGICAL HARDWARE APPEARS INTACT AND APPROPRIATELY POSITIONED¿LIMITED PASSIVE EXTENSION AND FLEXION RADIOGRAPHS IN LATERAL PROJECTION SHOW NO ABNORMAL SUBLUXATION AT C5-C6 OR ELSEWHERE IN THE CERVICAL SPINE¿. ON (B)(6) 2012, LUMBAR MRI WITHOUT CONTRAST REVEALED ¿MINOR DEGENERATIVE SPONDYLOSIS AND SPONDYLOARTHROPATHY AT L4-L5 AND L5-S1 WITH POTENTIAL MILD NEURAL FORAMINAL NARROWING¿OTHERWISE ESSENTIALLY NEGATIVE¿. ON (B)(6) 2012, CERVICAL MRI WITHOUT CONTRAST REVEALED ¿C4-C5 MILD CENTRAL AND VERY MILD BILATERAL FORAMINAL STENOSIS, AND C5-C6 POST OPERATIVE FUSION WITH MILD CENTRAL STENOSIS WITH THE PATIENT IN THE NEUTRAL POSITION¿. ON (B)(6) 2012, THE PATIENT PRESENTED WITH COMPLAINTS OF NECK, UPPER SHOULDER, LOWER BACK AND SCAPULAR REGION. THE PATIENT ALSO NOTED SOME WEAKNESS IN THE HANDS AND LEFT UPPER EXTREMITY PAIN. TREATMENT WAS NOT NOTED ON DOCUMENT. ON (B)(6) 2012, CERVICAL X-RAYS REVEALED ¿POSTERIOR FUSION WITH METALLIC FIXATION AT C5-C6 WITH NO SIGNIFICANT MOTION ON FLEXION AND EXTENSION VIEWS; AND NO BROKEN SCREW OR LOOSENING¿. ON (B)(6) 2013, PATIENT PRESENTED TO PHYSICAL THERAPY WITH COMPLAINTS OF ¿WHEN IT¿S COLD LIKE THIS MY BODY HURTS REAL BAD, THEY HAD TO INCREASE MY MEDICINE¿.MY LEFT SHOULDER FEELS WEAK¿MY HANDS GO NUMB SOMETIMES..¿. TREATMENT INCLUDED PHYSICAL THERAPY, TENS TRIAL AT NEXT VISIT, AND RETURN TO CLINIC IN 1-2 WEEKS. ON (B)(6) 2013, PATIENT PRESENTED TO PHYSICAL THERAPY WITH COMPLAINTS OF ¿LOT OF PAIN, MY HANDS ARE GOING NUMB, THE BACK AND NECK ARE REAL BAD¿. TREATMENT INCLUDED TENS APPLICATION FOR 30 MINUTES WITH NO ADVERSE EVENTS AND RETURN TO CLINIC IN 1-2 WEEKS. ON (B)(6) 2013, PATIENT PRESENTED TO EMERGENCY ROOM WITH COMPLAINTS OF THREE DAYS OF LEFT HAND PAIN. PATIENT STATED ¿LEFT HAND IS WEAK, SHAKES AND HAS CONSTANT CHRONIC PAIN¿.INTERVAL DEVELOPMENT OF A LEFT HAND CYST WITH WILL DISAPPEAR AND REOCCUR¿. TREATMENT INCLUDED A CONSULT TO AN ORTHRO CLINIC. ON (B)(6) 2013, LEFT WRIST X-RAY REVEALED ¿NO SIGNIFICANT OSSEOUS ABNORMALITY NOTED¿. ON (B)(6) 2013, THE PATIENT PRESENTED WITH COMPLAINTS OF HAND PAIN, CRAMPING AND SHAKING. SHE ALSO COMPLAINS OF SWELLING WORSE IN HER RIGHT HAND THAN HER LEFT HAND, NECK AND BACK PAIN. TREATMENT INCLUDED ¿BONE SCAN, INCREASE GABAPENTIN TO 600MG, TRIAL OF TRAZADONE 50MG QHS PRN, ENCOURAGE HER TO GET SOME DEGREE OF LIGHT TO MODERATE CARDIOVASCULAR ACTIVITY AT LEAST 3-4 TIMES PER WEEK FOR WEIGHT LOSS AS WELL AS TO HELP HER POTENTIAL FIBROMYALGIA¿. ON (B)(6) 2013, BONE SCAN REVEALED ¿NO EVIDENCE OF CRPS (COMPLEX REGIONAL PAIN SYNDROME); AND FOCAL INCREASED UPTAKE IN THE LEFT WRIST, KNEES, AND MID FEET CONSISTENT WITH ARTHRITIS¿. ON (B)(6) 2013, THE PATIENT PRESENTED FOR A PLASTIC SURGERY OUTPATIENT CONSULT. TREATMENT INCLUDED RECOMMEND RULING OUT RHEUMATOLOGIC CONDITIONS FOR JOINT PAINS AND FOLLOW UP WITH SPINE SURGEON. ON (B)(6) 2013, THE PATIENT PRESENTED FOR FOLLOW UP AND COMPLAINS OF CHRONIC HAND PAIN/SWELLING, CHRONIC NECK PAIN STATUS POST CERVICAL FUSION, CHRONIC LOW BACK PAIN, AND CHRONIC KNEE PAIN. TREATMENT INCLUDED CONTINUE WITH GABAPENTIN, START ON TRAZADONE, DISCONTINUE NAPROXEN, START ON MELOXICAM, REFERRAL TO RHEUMATOLOGY, AND FOLLOW UP WITH NEUROSURGEON FOR RE-EVALUATION. ON (B)(6) 2013, PATIENT WAS EVALUATED BY RHEUMATOLOGY. TREATMENT INCLUDED CHECK TSH, HEPATITIS B/C SCREEN, AND LFTS; LUMBAR SPINE X-RAY; CT SCAN OF CERVICAL SPINE; AND NEUROLOGY REFERRAL TO EVALUATE TREMORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530784 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 Other