BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2962492 · Received February 14, 2013

    Report

    Report Number
    1030489-2013-00502
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    April 27, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE USING RHBMP-2/ACS. POST-OP, THE PATIENT IS REQUIRED "TO FREQUENTLY VISIT MY DOCTOR. I'M IN A LOT OF PAIN AND I'M WORRIED THINGS WILL GET WORSE."

    Description of Event or Problem · 1

    ON (B)(6) 2007: LUMBAR EPIDURAL STEROID INJECTION WITH FLUOROSCOPE GUIDANCE SYMPTOMS: BILATERAL, LEFT AND RIGHT SIDED BACK/LEG PAIN WITH FAILURE OF CONSERVATIVE THERAPY RETURN IN 2 WEEKS AND DETERMINE NEXT STEPS (B)(6) 2007: CERVICAL SPINE MRI WITHOUT CONTRAST, NECK PAIN WITH BILATERAL UPPER EXTREMITY NUMBNESS. FINDINGS: C4-5 THERE IS ANTERIOR DISC BULGING. C5-6 DISC BULGING OPINION: CENTRAL POSTERIOR PROTRUSION OF C4-5 DISC WITHOUT ASSOCIATED SIGNIFICANT CENTRAL SPINAL STENOSIS (B)(6) 2007: DR VISIT: HISTORY: THIS (B)(6), FEMALE PRESENTED TO A CHRONIC PAIN CLINIC HAVING FAILED MULTIPLE PRIMARY AND CONSERVATIVE INTERVENTIONS FOR COMPLAINTS OF NECK AND LOW BACK PAIN. PATIENTS STATES THAT SHE HAS MIGRAINES, BUT SL1E DOES NOT PRESENT WITH THIS SEVERITY OF PAIN TODAY. EXAM FINDINGS: DECREASED RANGE OF MOTION WITH PALPABLE TENDERNESS OF LUMBOSACRAL SPINE AND C-SPINE WITH INHIBITION AND LIMITATION TO FULL PRESENTATION OF RANGE OF MOTION WAS DONE WITH TODAY'S EXAM. INCREASED DYSESTHESIA TO NUMBNESS OF BILATERAL BANDS PREVIOUS INJECTIONS HAVE IMPROVED HER MOBILITY DECREASED QUALITY OF LIFE ASSESSMENT: DEGENERATIVE DISC DISEASE. HERNIATED NUCLEUS PROPUISCI C-SPINE SPONDYLOSIS LUMBAR SPONDYLOSIS DATE: (B)(6) 2007 PROCEDURE: CERVICAL TRANSFORAMINAL EPIDURAL STEROID INJECTION BILATERALLY, UNDER FLUOROSCOPIC GUIDANCE C5-6 DIAGNOSIS: CERVICAL SPONDYLOSIS W/O MYELOPATHY DISPLACEMENT OF CERVICAL INTERVERTEBRAL DISC W/O MYELOPATHY CERVICALOIA CERVICAL RADICLJLOPATHY SYMPTOMS: RADICULAR LEFT NECK AND ARRR PAIN WITH FAILURE OF CONSERVATIVE THERAPY. RADICULAR RIGHT NECK AND ARM PAIN WITH FAILURE OF CONSERVATIVE THERAPY. FOLLOW UP: PATIENT WILL RTC IN 2-3 WEEKS. CONSIDER REPEAT INJECTION IN TWO TO THREE WEEKS. IF PAIN IS NOT REDUCED WE MAY HAVE TO DO EPIDURAPLASTY. EXAM DATE: (B)(6) 2007 PROCEDURE: CERVICAL TRANSFORAMINAL EPIDURAL STEROID INJECTION BILATERALLY, UNDER FLUOROSCOPIC GUIDANCE C5-6 C6- 7 BILATERAL DIAGNOSIS: CERVICAL SPONDYLOSIS "WIOMYELOPATHY" DISPLACEMENT OF CERVICAL INTERVERTEBRAL DISC W/O MYELOPATHY CERV1CALGLA CERVICAL RADICULOPATHY SYMPTOMS: RADICULAR LEFT NECK AND ARM PAIN WITH FAILURE OF CONSERVATIVE THERAPY. RADICULAR RIGHT NECK WITH FAILURE OF CONSERVATIVE THERAPY; 60% SYMPTOMS IMPROVED WITH PREVIOUS INJECTION. AOL IMPROVED DRAMATICALLY. FOLLOW UP: PATIENT WILL RTC IN 2-3 WEEKS. CONSIDER REPEAT INJECTION IN TWO TO THREE WEEKS. IF PAIN IS NOT REDUCED WE MAY HAVE TO DO EPIDURAPLASTY. ON (B)(6) 2007: X-RAY LUMBAR SPINE WITHOUT CONTRAST. L4/5 GRADE 3 DISC DISRUPTION NOTED. SCLEROSIS AROUND THE SACROILIAC JOINTS BILATERALLY GREATER ON THE RIGHT THAN ON THE LEFT. ON (B)(6) 2008: ADMITTED TO HOSPITAL, ADMISSION DIAGNOSIS: LUMBAR SPONDYLOSIS, MAST SPINAL FUSION. PRINCIPAL DIAGNOSIS: L1/L5 MAST TLIF WITH INSTRUMENTATION AND INFUSE BMP MAST TLIF L4/L5 WITH BILATERAL PEDICLE SCREW INSTRUMENTATION. ANTERIOR INTERBODY FUSION L4/LS WITH PLACEMENT OF INTERBODY SPACER, AUGMENTATION OF ANTERIOR SPINAL FUSION L4/LS WITH BONE MORPHOGENIC PROTEIN AND LOCAL BONE GRAFT. POSTERIOR LATERAL AND POSTERIOR SPINAL FUSION L4/LS AUGMENTED WITH BONE MORPHOGENIC PROTEIN AND LOCAL BONE GRAFT. NEURAL MONITORING WITH SOMATOSENSORY EVOKED POTENTIALS AND EMGS. BMP AND CRESCENT PEEK SPACER (B)(6) 2011: OBSTRUCTION SERIES, RADIOLOGY REPORTED CHRONIC CONSTIPATION AND PAIN. LUNG BASES ARE CLEAR, NO EVIDENCE OF BOWEL OBSTRUCTION OR PERFORATION. COLON FULL OF STOOL ALL THE WAY TO RECTUM. STATUS: PRIOR L4/L5 FUSION SURGERY WITH TRANSPEDICULAR SCREWS AND DORSAL SPACER BARS IN PLACE. ON (B)(6) 2008: PRESENTED TO ER, PATIENT STATES SHE TOOK 20 AMBIEN, WAS TIRED OF CONSTANT PAIN. PATIENT MONITORED AND CLAIMS SHE HAS NO SUICIDAL THOUGHTS, JUST WANTED TO EASE PAIN. PATIENT WAS RELEASED TO HUSBANDS CARE. ON (B)(6) 2009: NERVE CONDUCTION TEST, PRIOR SPINAL FUSION, COMPLAINS OF HEAD AND NECK PAIN. CONCLUSION: THERE IS NEUROPHYSIOLOGIC EVIDENCE FOR LEFT PERONEAL NEUROPATHY. CONSIDER L5 RADICULOPATHY AS A POSSIBILITY, CLINICAL CORRELATION REQUIRED. ON (B)(6) 2009: CERVICAL SPINE MRI W/O CONTRAST, NO PREVIOUS STUDIES FOR COMPARISON BILATERAL NECK PAIN AND HAND NUMBNESS C4/5 AND C6/7 MILD DISC BULGE NOTED NO SIGNIFICANT CENTRAL CANAL OR NEURAL FORAMINAL STENOSIS (B)(6) 2009: PATIENT CONSULT, PATIENT COMPLAINS OF LOW BACK PAIN, RIGHT AND LEFT ANKLE/FOOT PAIN, NECK AND MID BACK PAIN AND HAND AND LEFT WRIST PAIN. SAYS SYMPTOMS STARTED 4 YEARS AGO NECK EXAMINATION REVEALS NORMAL BUT PAINFUL RANGE OF MOTION, PAIN WITH FLEXION AND EXTENSION OF LUMBAR SPINE, SACRO ILIAC JOINT TENDERNESS BILATERALLY. INJECTION PROCEDURES TO INCLUDE A CERVICAL EPIDURAL STEROID INJECTION WHICH WILL BE DONE TODAY. PATIENT REPORTS HISTORY OF ARTHRITIS, BOWEL/BLADDER PROBLEM, DEPRESSION, JOINT PROBLEMS, MIGRAINE HEADACHES, SLEEP DISTURBANCE AND STOMACH / INTESTINAL PROBLEMS. OCD BIPOLAR PANIC ATTACKS (B)(6) 2011: LEFT WRIST X-RAYS, PAIN AFTER A FALL. FINDINGS: THERE IS NO DISLOCATION SUBLUXATION, FRACTURE OR EVIDENCE FOR JOINT EFFUSION. NO FOCAL BONE TEXTURE ABNORMALITY IS SEEN. SOFT TISSUE ABNORMALITY IS NOT IDENTIFIED. ON (B)(6) 2011: CT HEAD NO CONTRAST, LEFT HAD TRAUMA AFTER FALL, FINDINGS NO ACUTE INFARCTION, MASS, MASS EFFECT, HEMORRHAGE. ON (B)(6) 2011: LEFT ANKLE VIEWS, PAIN AFTER FALL. THERE IS NO DISLOCATION, SUBLUXATION, FRACTURE OR EVIDENCE FOR JOINT EFFUSION. NO FOCAL BONE TEXTURE ABNORMALITY IS SEEN. SOFT TISSUE ABNORMALITY IS NOT IDENTIFIED. ON (B)(6) 2011: CT CERVICAL SPINE PAIN AFTER FALL. FINDINGS: CT CERVICAL SPINE WITHIN NORMAL LIMITS. NO ACUTE FRACTURE, COMPRESSION, OR SUBLUXATION. ON(B)(6) 2011: ER VISIT DUE TO KNEE PAIN. GIVEN CRUTCHES AND REFERRED TO ORTHOPEDIC SURGEON FOR FOLLOW UP. ON (B)(6) 2011: CERVICAL SPINE MAGNETIC RESONANCE IMAGING WITHOUT CONTRAST. C4/5 AND C6/7 DISC OSTEOPHYTE COMPLEX IS PRESENT. VERY MILD CERVICAL SPONDYLOSIS UNCHANGED SINCE PREVIOUS EXAM FROM (B)(6) 2009. STRAIGHTENING OF THE CERVICAL LORDOSIS. ON (B)(6) 2012: X-RAY RIGHT HIP AND PELVIS. PAIN AND DECREASED RANGE OF MOTION. NO ACUTE FRACTION OR DISLOCATION NOTED. LUMBAR SPINE VIEWS, COMPLAINT OF LOW BACK PAIN. NO ACUTE FRACTION OR SUBLUXATION NOTED. ON (B)(6) 2012: HOSPITAL VISIT: PATIENT COMPLAINS OF VOMITING, PAIN IN ARMS, TIGHTNESS IN CHEST, HASN'T HAD BOWEL MOVEMENT IN A MONTH. MONITORED AND REFERRED TO A NON STAFF PHYSICIAN FOR FOLLOW UP. TESTS SHOW NOTHING ACUTE IN EXAM TODAY. MILD CONSTIPATION NOTED. FOLLOW UP WITH PRIMARY CARE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65268 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110608AAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other