BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3840766 · Received May 30, 2014

    Report

    Report Number
    1030489-2014-02664
    Event Type
    Death
    Date Received
    May 30, 2014
    Report Date
    May 7, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: HUGHES ET AL. CASE REPORT: MULTIPLE MYELOMA EXACERBATION FOLLOWING UTILIZATION OF BONE MORPHOGENETIC PROTEIN-2 IN LATERAL-LUMBAR INTERBODY FUSION: A CASE REPORT AND REVIEW OF THE LITERATURE. THE SPINE JOURNAL, 14 (2014) E13¿E19. DATE OF DEATH WAS NOT REPORTED. (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 IN A LITERATURE PUBLICATION THAT THE PATIENT PRESENTED WITH ACUTE ONSET OF SUBJECTIVE WEAKNESS IN HER RIGHT LEG AND SIGNIFICANT WALKING CAPACITY IMPAIRMENT OVER THE PAST 6 MONTHS. SHE HAD NOT RESPONDED TO EXTENSIVE CONSERVATIVE INTERVENTIONS AND CONTINUED TO LOSE FUNCTION AND INDEPENDENCE. NEUROLOGIC EVALUATION REVEALED GLOBALLY DECREASED STRENGTH OVER BOTH LOWER EXTREMITIES OF 4+/5 AND RIGHT LOWER EXTREMITY QUADRICEPS AND TIBIAL ANTERIOR AT 3/5. THE PATIENT WAS DEEMED A HIGHRISK SURGICAL CANDIDATE NOT AMENABLE TO LARGE FLUID SHIFTS AND OPERATIVE TIME. RADIOGRAPHIC STUDIES DEPICTED LUMBAR DEGENERATIVE SCOLIOSIS WITH MULTILEVEL LATERAL SPONDYLOLISTHESIS WITH SEVERE MULTILEVEL FORAMINAL STENOSIS BUT MILD CENTRAL STENOSIS. PREOPERATIVE SERUM IMMUNOFIXATION ELECTROPHORESIS, SHOWED A SERUM IMMUNOGLOBULIN A (IGA) KAPPA PARAPROTEIN-PEAK; HOWEVER, THE PATIENT HAD NEVER BEEN DIAGNOSED WITH MM NOR REPORTED ANY UNEXPLAINED FEVER, NIGHT SWEATS, OR WEIGHT LOSS. THEREFORE, THE PLAN WAS TO EVALUATE THE PARAPROTEIN PEAK POSTOPERATIVELY AS AN OUTPATIENT. THE PATIENT UNDERWENT A FOUR-LEVEL MINIMALLY INVASIVE STAND ALONE LATERAL LUMBAR INTERBODY FUSION (LLIF) (L1¿L5) FOR INDIRECT FORAMINAL DECOMPRESSION ACCORDING TO A WELL ESTABLISHED PROTOCOL. IN BRIEF, FOLLOWING THE INSERTION OF RETRACTORS, BLUNT PSOAS DISSECTION, AND DISCECTOMY, NUVASIVE POLYETHER-ETHER-KETONE CAGES, LOADED WITH DEMINERALIZED BONE MATRIX, AND A TOTAL OF 12 MG BMP-2/ACS, WERE IMPLANTED. THERE WERE NO INTRAOPERATIVE COMPLICATIONS, AND POSTOPERATIVE X-RAY IMAGING STUDIES DEMONSTRATED ADEQUATE CAGE IMPLANTATION AND PARTIAL REDUCTION OF HER LATERAL SPONDYLOLISTHESIS AND LUMBAR SCOLIOSIS. IMMEDIATELY AFTER SURGERY, THE PATIENT WAS NEUROVASCULARLY INTACT WITH IMPROVEMENT IN LOWER EXTREMITY PAIN. ON POSTOPERATIVE DAY 1, THE PATIENT WAS EVALUATED BY THE HEMATOLOGY DEPARTMENT FOR PARAPROTEINEMIA. SERUM ELECTROPHORESIS SHOWED DECREASED ALBUMIN, HYPOGAMMAGLOBULINEMIA, AND SUSPICIOUS BROADENING OF THE COMPLEMENT COMPONENT IN THE BETA REGION. IMMUNOFIXATION ELECTROPHORESIS REVEALED A MONOCLONAL KAPPA IGA COMPONENT (SERUM), AND MONOCLONAL KAPPA LIGHT CHAINS (URINE). FOUR DAYS AFTER SURGERY, THE PATIENT WAS DISCHARGED AND HER HEMATOLOGY WORKUP WAS ARRANGED TO BE COMPLETED AS AN OUTPATIENT. AT 6 WEEKS FOLLOW-UP, THE PATIENT WAS ABLE TO AMBULATE WITH A WALKER AND REPORTED MARKED IMPROVEMENT OF HER PREOPERATIVE COMPLAINTS, BUT MILD LOWER BACK PAIN (VISUAL ANALOG SCALE: 2/10), PERSISTENT NUMBNESS, AND PARAESTHESIAS IN HER TOES. HER LOWER EXTREMITY MOTOR FUNCTION HAD IMPROVED TO 4+/5 GLOBAL STRENGTH. TWELVE WEEKS AFTER SURGERY, THE PATIENT PRESENTED FOR AN EMERGENCY VISIT COMPLAINING OF LOCALIZED SHARP LOWER BACK PAIN AND REDUCED WALKING CAPACITY. POSTOPERATIVE CT IMAGING STUDIES DEPICTED POOR LUMBAR BONE QUALITY. COMPARED WITH PREOPERATIVE CT IMAGING STUDIES, POSTOPERATIVE CT SCANS (AT 19 WEEKS FOLLOW-UP) DEPICTED PROGRESSION OF A PREVIOUSLY VISIBLE INTRAOSSEOUS LESION, AND ANTERIOR CORTICAL BREAKTHROUGH WITHIN THE L5 VERTEBRA. LUMBAR MRI STUDIES DEPICTED A FOCALLY AGGRESSIVE MASS WITH INCREASED T2 SIGNAL INTENSITY WITHIN THE L5 VERTEBRA BREAKING THROUGH THE ANTERIOR CORTEX, IN ADDITION TO A SOFT TISSUE MASS (10X13X7 MM) AT THE T10 LEVEL, MOST LIKELY REPRESENTING AN EPIDURAL TUMOR MASS EXTENSION, LATERALLY DISPLACING THE SPINAL CORD. HISTOLOGICAL EXAMINATION OF ILIAC CREST AND T10 VERTEBRAL BIOPSIES SHOWED FATTY MARROW INFILTRATION BY PLASMA CELLS AND PLASMA CELL DYSCRASIA, PROVING THE DIAGNOSIS OF MM THIS WAS FOLLOWED BY RADIATION THERAPY AND CHEMOTHERAPY, WITH A RESULTING DECREASE IN PARAPROTEIN LEVELS; HOWEVER, 8 MONTHS AFTER SURGERY THE PATIENT WAS STILL COMPLAINING OF BACK PAIN, REDUCED WALKING CAPACITY, AND PARAESTHESIAS IN HER FEET. FURTHERMORE, THE PATIENT PRESENTED WITH DETERIORATION OF HER KIDNEY/LIVER FUNCTION, AND A (B)(6) BLADDER INFECTION. THE PATIENT DIED 10 MONTHS AFTER SURGERY DUE TO COMPLICATIONS RELATED TO HER (B)(6) INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319232 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_BMP2_ACS

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death| R