BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2945507 · Received February 6, 2013

    Report

    Report Number
    1030489-2013-00387
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 9, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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) 2010: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: DEGENERATIVE DISK DISEASE AT L5-S1, LUMBAR INSTABILITY. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: ANTERIOR LUMBAR INTERBODY ARTHRODESIS, L5-S1. PLACEMENT OF ANTERIOR LUMBAR PLATE, ANTERIOR INSTRUMENTATION (SYNTHES LUMBAR PLATE); INSERTION OF A BIOMECHANICAL DEVICE AT L5-S1 (SYNTHES PEEK SPACER FILLED WITH MORSELLIZED ALLOGRAFT); USE OF MORSELLIZED ALLOGRAFT. PER OP NOTES, AFTER THE DISK SPACE WAS PREPARED, A BIOMECHANICAL DEVICE WHICH WAS A SYNTHES PEEK SPACER, 11 MM IN HEIGHT, FILLED WITH BMP AND MORSELLIZED ALLOGRAFT WAS NOW COUNTERSUNK INTO POSITION USING THE SQUID DEVICE. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON SAME DAY, PATIENT ALSO HAD PRE-OP DIAGNOSIS AS RIGHT SIDED L5-S1 RADICULOPATHY WITH LUMBAR LATERAL RECESS STENOSIS. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: RIGHT SIDED L5-S1 HEMILAMINECTOMY, FORAMINOTOMY, MEDIAL FACETECTOMY FOR DECOMPRESSION OF THE L5-S1 NERVE ROOTS. MICRODISSECTION TECHNIQUE. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2011: PATIENT UNDERWENT CAT SCAN OF LUMBAR SPINE. IMPRESSION: PREVIOUS POSTERIOR FUSION AT THE L2 THROUGH L4 LEVELS ALONG WITH PREVIOUS ANTERIOR INTERBODY FUSION AT THE L5-S1 LEVEL. PROMINENT LEFT SIDED OSTEOPHYTIC SPURRING AT THE L3-4 LEVEL CONTRIBUTING TO MODERATELY SEVERE TO SEVERE NARROWING OF THE LEFT NEURAL FORAMEN. PREVIOUS LAMINOTOMY ON THE RIGHT AT L5. DISC BULGES WITHOUT EVIDENCE OF SPINAL STENOSIS. PATIENT ALSO UNDERWENT MRI OF LUMBAR SPINE W/WO CONTRAST. IMPRESSION: L3-4 LEFT FORAMINAL STENOSIS. THERE IS NO EVIDENCE OF ABNORMAL ENHANCEMENT. PREVIOUS FUSION AS DESCRIBED AS ABOVE. ON (B)(6) 2012: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: LUMBAR STENOSIS INCLUDING NEUROFORAMINAL STENOSIS L3-4; L4-5. LUMBAR DEGENERATIVE DISK DISEASE WITH INSTABILITY AT L4-5. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: POSTEROLATERAL ARTHRODESIS AT L4-5. DECOMPRESSION WITH LAMINECTOMY, FORAMINOTOMY FACETECTOMY ON THE LEFT SIDE AT L3-4 WITH DECOMPRESSION OF THE L3 NERVE ROOT. FACETECTOMY AND FORAMINOTOMY AT L4-5 ON THE LEFT SIDE WITH DECOMPRESSION OF THE L4 NERVE ROOT. POSTERIOR SPINAL INSTRUMENTATION AT L4-5 ON THE LEFT SIDE. BONE MARROW ASPIRATION. USE OF MORSELIZED ALLOGRAFT. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2012: PATIENT UNDERWENT MRI OF LUMBAR SPINE. IMPRESSION: VERY METALLIC ARTIFACTUAL EXAMINATION. SEQUELA OF THE PRIOR POSTEROLATERAL AND ANTERIOR FUSION. THERE WAS NO EVIDENCE OF EPIDURAL MASS EFFECT AND THERE WAS NO EVIDENCE OF ABNORMAL ENHANCEMENT. ON (B)(6) 2012: PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS CERVICAL SPONDYLOSIS WITH CERVICAL RADICULOPATHY RIGHT SIDE C5. FOR WHICH PATIENT UNDERWENT FOLLOWING PROCEDURES: ANTERIOR CERVICAL DISKECTOMY AND DECOMPRESSION C4-5; ANTERIOR CERVICAL ARTHRODESIS C4-5; ANTERIOR CERVICAL SPINAL INSTRUMENTATION C4-5; INSERTION OF BIOMECHANICAL DEVICES AT C4-5; USE OF MORSELLIZED ALLOGRAFT. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2012: PATIENT UNDERWENT CAT SCAN OF LUMBAR SPINE. IMPRESSION: EXTENSIVE POSTOP CHANGES. NEAR COMPLETE LOSS OF LEFT LATERAL DISC SPACE HEIGHT AT L3-L4 WITH APPARENT DEGENERATION OF THE DISC SPACER AND EXUBERANT OSTEOPHYTOSIS ALONG THE LEFT LATERAL DISC SPACE CONTRIBUTE TO SEVERE NARROWING OF THE LEFT FORAMEN WITH MASS EFFECT UPON EXITING LEFT L3 NERVE ROOT. DISC OSTEOPHYTE ENCROACHMENT CONTRIBUTES TO MODERATE NARROWING OF THE RIGHT L5-S1 FORAMEN. PATIENT UNDERWENT MRI OF LUMBAR SPINE W/WO CONTRAST DUE TO HISTORY OF LEFT LEG PAIN. IMPRESSION: POSTEROLATERAL TRANSPEDICULAR FUSION AT L2, L3 AND L4 AND ANTERIOR FUSION AT L5-1 WAS NOTED. THERE WAS NO VERTEBRAL FRACTURE OR DISLOCATION. THE T11-T12; T12-L1 DISC SPACE, SPINAL CANAL AND FORAMINAL ARE NORMAL. ON (B)(6) 2013: PATIENT UNDERWENT MRI OF CERVICAL SPINE WITHOUT CONTRAST. IMPRESSION: PREVIOUS ANTERIOR FUSION AT THE C4-5 LEVEL. REVERSAL OF NORMAL CERVICAL LORDOSIS. NO EVIDENCE OF RECURRENT DISC PROTRUSION OR SPINAL STENOSIS. MILD DISC BULGES AS DESCRIBED ABOVE AT THE C3-4, C5-6 AND C6-7 LEVELS. QUESTIONABLE CERVICAL CORD ATROPHY AT THE C4-5 LEVEL. THIS FINDING IS LIKELY CHRONIC IN NATURE SOMEWHAT RELATED TO THE REVERSAL OF THE NORMAL CERVICAL LORDOSIS. NO ABNORMAL ENHANCEMENT IS SEEN WITHIN THE CORD. PATIENT ALSO UNDERWENT MRI OF LUMBAR SPINE WITH AND WITHOUT CONTRAST. IMPRESSION: PREVIOUS POSTERIOR FUSION AT THE L2-3 AND L3-4 LEVELS. PREVIOUS ALIF AT THE L5-S1 LEVEL. MILD TO MODERATE CENTRAL DISC BULGE AT THE L4-5 LEVEL CAUSING MODERATE MASS EFFECT UPON THE THECAL SAC. THERE WAS MILD NEURAL FORAMEN NARROWING BILATERALLY AT THIS LEVEL SECONDARY TO FACET JOINT DEGENERATIVE CHANGES. DISC BULGE HAD PROGRESSED WHEN COMPARED TO (B)(6) 2012. NO ABNORMAL ENHANCEMENT IS IDENTIFIED. NO FINDINGS OF FRACTURE. PATIENT ALSO UNDERWENT MRI OF THORACIC SPINE W/WO CONTRAST. IMPRESSION: STABLE MRI OF THE THORACIC SPINE DEMONSTRATING SCATTERED HEMANGIOMA WITH NO EVIDENCE OF ENHANCING MASS OR LESION. THE THORACIC CORD IS NORMAL IN SIGNAL. NO EVIDENCE OF FRACTURE OR SUBLUXATION. ON (B)(6) 2014: PATIENT UNDERWENT MRI OF LUMBAR SPINE W/WO CONTRAST DUE TO INDICATION OF LOW BACK PAIN WITH RIGHT LOWER EXTREMITY RADICULAR SYMPTOMS. IMPRESSION: THERE IS MILD RIGHT-SIDED NEURAL FORAMINAL NARROWING AT L5-S1 WITH NO OTHER POTENTIAL CAUSE OF RIGHT SIDE RADICULAR SYMPTOMS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: ON (B)(6) 2010 THE PATIENT UNDERWENT SPINE FUSION SURGERY WITH RHBMP-2 AND ACS ON THE LUMBAR REGION OF HER SPINE FROM VERTEBRAE L5 TO S1. PATIENT CONTINUED TO EXPERIENCE CHRONIC LOWER BACK PAIN, RADIATING LEG PAIN, AND MUSCLE SPASMS. PATIENT WAS UNABLE TO SIT OR STAND FOR EXTENDED PERIODS, AND REQUIRED USE OF A CANE TO ASSIST IN AMBULATION. PATIENT ALSO SUFFERED FROM DEPRESSION AND ANXIETY. THESE SERIOUS INJURIES PREVENT PATIENT FROM PRACTICING AND ENJOYING THE ACTIVITIES OF DAILY LIFE THAT SHE ENJOYED PRE-OPERATIVELY, AND SHE OTHERWISE SUFFERED SERIOUS AND PERMANENT INJURIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN OFFICE VISIT. PER THE PHYSICIAN'S NOTES, "AT L5-S1, THERE IS RIGHT SIDED PARACENTRAL DISC PROTRUSION THAT WAS POINTED OUT TO THE PATIENT" THERE IS ALSO FORAMINAL STENOSIS AT THAT LEVEL "THERE IS OSTEOPHYTOSIS AT THE L3/4 LEVEL BUT THIS IS ON THE LEFT SIDE BUT THE PATIENT IS NOT SIGNIFICANTLY SYMPTOMATIC ON THE LEFT SIDE." THE PATIENT UNDERWENT ANTERIOR LUMBAR INTERBODY ARTHRODESIS AT L5/S1 AND PLACEMENT OF SYNTHES ANTERIOR LUMBAR PLATE AND SYNTHES PEEK SPACER FILLED WITH ALLOGRAFT AND RHBMP-2/ACS. AT 162 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP OFFICE VISIT. PATIENT FEELS LIKE SHE HAS IMPROVEMENT IN HER SYMPTOMS AND HER BACK PAIN BUT THE BACK PAIN AND SPASMS ARE STILL PRESENT, NOT AS BAD AS BEFORE. SHE FEELS LIKE SHE IS ABLE TO WALK BETTER AND STILL HAS ISSUES WITH HER BACK. AT 324 DAYS POST-OP, THE PATIENT UNDERWENT A LUMBAR CT. THE STUDY WAS INTERPRETED TO INDICATE AT L3/4 THERE IS PROMINENT LEFT SIDE OSTEOPHYTIC SPURRING AT THE LEVEL BOTH ANTERIORLY AND POSTERIORLY EXTENDING INTO THE LEFT NEURAL FORAMEN CAUSING MODERATELY SEVERE NARROWING OF THE LEFT NEURAL FORAMEN. AT 337 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, THERE IS SOME LEFT SIDE OSTEOPHYTE AND NEURAL FORAMINAL STENOSIS AT L3/4. THERE IS NO EVIDENCE OF ANY NEURO COMPRESSION ON THE RIGHT SIDE. THERE IS LEFT SIDE AND OSTEOPHYTIC SPURRING ANTERIORLY AND POSTERIORLY. THERE IS NARROWING OF THE LEFT NEURAL FORAMINA. AT 630 DAYS POST-OP, THE PATIENT UNDERWENT A LUMBAR MRI. THE IMAGING STUDY WAS INTERPRETED TO INDICATE "AT L3/4 SEVERE DISC SPACE NARROWING WITH LEFT FORAMINAL STENOSIS. AT L4/5 MILD BROAD BASED BULGING DISC WITH TEAR OF THE ANNULUS FIBROSUS PRODUCING MILD COMPRESSION AND DEFORMITY OF THE DURAL SAC WITH BILATERAL HYPERTROPHY ARTICULAR FACETS PREDOMINATE ON THE LEFT SIDE PRODUCING LEFT FORAMINAL STENOSIS." A LUMBAR CT SCAN WAS INTERPRETED TO SHOW "AT L3/4 EXUBERANT OSTEOPHYTE IS PRESENT EXTENDING FROM THE LEFT LATERAL MARGIN OF THE DISC SPACE. AT L5/S1 DISC OSTEOPHYTE ENCROACHMENT CONTRIBUTES TO MODERATE NARROWING OF THE RIGHT FORAMEN." AT 635 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, THE CT SCAN AND MRI SCAN IS NOT VERY DIFFERENT THAN LAST CLINIC VISIT BUT STILL SHOWS OSTEOPHYTOSIS AT L3/4. AT 680 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PATIENT RECENTLY IN HOSPITAL FOR INCREASING PAIN ON LEFT SIDE. PATIENT STATED THAT THE LEG PAIN WAS GETTING BETTER AND AMBULATION WAS GETTING BETTER. PATIENT STILL HAS NUMBNESS IN HER HEEL AND CALF OF THE LEFT FOOT OTHERWISE THE PATIENTS STRENGTH IS GETTING BETTER IN THE LEFT LEG AND THE WEAKNESS IS GETTING BETTER. REPORTEDLY, THE PATIENT "DEVELOPED OVERGROWN BONE, EXPERIENCED SIGNIFICANT PAIN AND SUFFERED OTHER SERIOUS INJURIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50427 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