BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2863890 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02723
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    April 25, 2013
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF IMAGING STUDIES FOUND AS FOLLOWS: (B)(6) 2006 LUMBAR MYELOGRAM AND CT LUMBAR POST MYELOGRAM CT SHOWS PREVIOUS LAMINECTOMY AT L5/S1 WITH GOOD DECOMPRESSION, POSTEROLATERAL UNINSTRUMENTED LUMBAR FUSION NOTED, WHICH APPEARS FAIRLY RECENT WITHOUT SIGNIFICANT CONSOLIDATION OF POSTEROLATERAL GRAFT. NO CLEAR EVIDENCE OF ANY RESIDUAL STENOSIS, HOWEVER LEFT S1 ROOT APPEARS CONSOLIDATED IN SCAR AND SHEATH DOES NOT FILL. ROOT IS DISPLACED DORSALLY. (B)(6) 2009 CT LUMBAR POST MYELOGRAPHY SHOWS PREVIOUS CHANGES AND DISPLACEMENT OF HER LEFT S1 ROOT. SOME INCORPORATION OF THE PREVIOUS POSTEROLATERAL FUSION SINCE 2006. ALIF INTERBODY SPACER NOTED WITH ANTERIOR PLATES AND SCREWS IN GOOD POSITION. SOME CLUMPING OF THE NERVE ROOTS ARE NOTED PROXIMAL TO THE L4 LEVEL. (B)(6) 2009 X-RAY MYELOGRAM LUMBAR SHOWS QUAD PLATES PLACED ANTERIORLY AT L4 AND L5 WITH MYELOGRAM DYE. DYE COLUMN EXTENDS DOWN TO MID L5, THEN APPEARS TO TAPER ON THE AP. LATERAL IS UNDEREXPOSED, BUT APPEARS TO SHOW SOME STENOSIS AT THE L5/S1 AREA. (B)(6) 2012 CT LUMBAR PROGRESSIVE HEALING OF PREVIOUS LESIONS NOTED. INTERBODY FUSION IS SOLID AT BOTH LEVELS. POSTEROLATERAL FUSION APPEARS SOLID AS WELL. SOME CALCIFICATION IS NOTED VENTRAL TO THE LEFT S1 ROOT. (B)(6) 2012 OPEN MRI LUMBAR MRI SHOWS SOME APPARENT DISPLACEMENT OF THE LEFT S1 ROOT BY MATURE BONE. SOLID ARTHRODESIS IS PRESENT AT L4 AND L5. THE DEVICE WAS NOT 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. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L4-S1 ALIF USING A PLATE, INTERBODY CAGE AND RHBMP-2/ACS. THE SURGERY WAS PERFORMED TO TREAT POSTLAMINECTOMY SYNDROME, LUMBAR SPONDYLOSIS AND LUMBAR DISCOGENIC PAIN. PER THE OPERATIVE REPORT, "AT L5-S1, THE POSTERIOR OSTEOPHYTES WERE QUITE LARGE. I DRILLED DOWN AS MUCH AS SAFELY POSSIBLE. I WAS NOT ABLE TO REMOVE THE ENTIRE OSTEOPHYTE DUE TO THE EXTENSIVE SCARRING TO THE BACK OF THE THECAL SAC. HOWEVER, WE WERE ABLE TO BREAK THE SCAR TISSUE DOWN AND DISTRACT THE INTERVAL." THERE WERE NO NOTED COMPLICATIONS. AT 812 DAYS POST-OP, THE PATIENT PRESENTED WITH COMPLAINTS OF INTERMITTENT PAIN AND NUMBNESS RADIATING DOWN THE LEFT LOWER EXTREMITY. AN EMB/NCS INDICATED "LEFT L5 RADICULOPATHY: THE PATTERNS OF DENERVATION SUGGESTS A CHRONIC PROCESS (PRIOR AXON LOSS WITH SUBSEQUENT REINNERVATION). I DID NOT APPRECIATE ANY ELECTRICAL ABNORMALITIES TO SUGGEST ONGOING AXON LOSS (ACUTE DENERVATION)." AT 917 DAYS POST-OP, THE PATIENT PRESENTED WITH RECURRENT STENOSIS AND POST LAMINECTOMY SYNDROME. THE PATIENT UNDERWENT A SURGICAL PROCEDURE INCLUDING COMPLETION OF L4 LAMINECTOMY WITH REVISION RIGHT SIDED L4-5 AND L5-S1 LEFT SIDED NEURAL FORAMINOTOMIES. PER THE OPERATIVE NOTES, THE SURGEON FOUND "SEVERE COMPRESSION OF THE L5 AND S1 NERVE ROOTS ON THE LEFT SECONDARY TO BONY OSTEOPHYTIC OVERGROWTH." AT 1210 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK PAIN WITH LEFT LOWER EXTREMITY RADICULOPATHY, POST-OP LUMBAR SPINE SURGERY X4. AN MRI OF THE LUMBAR SPINE INDICATED "L4/L5 LEFT NEURAL FORAMINAL STENOSIS AND LEFT LATERAL RECESS NARROWING RELATED TO LEFT POSTERIOR OPPOSING ENDPLATE HYPERTROPHIC CHANGES. FACET HYPERTROPHIC CHANGES, AND SOME ENHANCING SCAR FORMATION IN THE LATERAL AND ANTEROLATERAL LEFT SPINAL CANAL. RECURRENT DISK IS NOT CONVINCINGLY DEMONSTRATED. THERE IS RESULTANT LEFT L5 DORSAL ROOT DISPLACEMENT. L5/S1 LEFT NEURAL FORAMINAL STENOSIS WITH LEFT S1 DORSAL ROOT DISPLACEMENT. THIS APPEARS TO BE RELATED TO LEFT POSTERIOR ECCENTRIC OPPOSING ENDPLATE HYPERTROPHIC CHANGES AS WELL AS PROMINENT ENHANCING SCAR AND THE LEFT LATERAL AND ANTEROLATERAL SPINAL CANAL. DISK HERNIATION NOT CONVINCINGLY DEMONSTRATED. STABLE POSTOPERATIVE CHANGES FROM L5/S1 LAMINECTOMY, ANTERIOR FUSION AT L4/L5 AND L5/S1 AND SOME LEFT POSTERIOR BONE GRAFT." AT 1217 DAYS POST-OP, THE PATIENT UNDERWENT AN EPIDURAL STEROID INJECTION. AT 1409 DAYS POST-OP, THE PATIENT UNDERWENT AN EPIDURAL STEROID INJECTION. AT 1813 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK PAIN AND POST LAMINECTOMY SYNDROME. AN MRI OF THE LUMBAR SPINE INDICATED "INTERVAL L5-S1 FUSION. SATISFACTORY POSTOPERATIVE APPEARANCE. NO ABNORMAL ENHANCEMENT. MILD L4-5 AND MODEST L5-S1 RESIDUAL LEFT BONY FORAMINAL ENCROACHMENT. NO RECURRENT OR RESIDUAL SOFT DISC PROTRUSION OR HERNIATION SEEN. SMALL LEFT L2-3 DISC BULGE." AT 1814 DAYS POST-OP, A CT SCAN OF THE LUMBAR SPINE INDICATED "L4-5 INTACT ANTERIOR PLATE AND SCREW DEVICE AND BONY FUSION. EPIDURAL FAT IS DISPLACED FROM AROUND THE LEFT L5 NERVE ROOT BY POSTERIOR SPUR BUT NO RECURRENT DISC PROTRUSION OR POSTOP FIBROSIS OR FLUID COLLECTION IS SEEN. L5-S1 INTACT ANTERIOR INTERBODY FUSION WITH LEFT S1 ROOT DISPLACEMENT BY A LARGE LEFT POSTERIOR SPUR. NO RECURRENT DISC PROTRUSION, SIGNIFICANT POSTOP FIBROSIS OR ABNORMAL FLUID COLLECTION." AT 1833 DAYS POST-OP, EMG/NCS INDICATED "LEFT L5 RADICULOPATHY: THE PATTERN OF DENERVATION SUGGESTS A CHRONIC PROCESS (PRIOR AXON LOSS WITH SUBSEQUENT REINNERVATION)." AT 1918 DAYS POST-OP, THE PATIENT UNDERWENT A REVISION LAMINECTOMY, FACETECTOMY AND FORAMINOTOMY ON THE LEFT TO TREAT POST-LAMINECTOMY SYNDROME, LUMBAR RADICULITIS, LUMBAR STENOSIS, AND CALCIFIED DISK HERNIATION. PER THE OPERATIVE NOTES, "THE CALCIFIED DISK AT THE 5-1 LEVEL HAD A MASSIVE OVERGROWTH." THERE WERE NO NOTED COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION AT LEVELS L4-S1 WITH A COUGAR SPACER CAGE DEVICE AND RHBMP-2/ACS. THE PATIENT¿S POST-OPERATIVE PERIOD WAS MARKED BY INCREASING BACK PAIN, SHOOTING AND BURNING PAIN DOWN HIS LEFT LEG, AND LEFT FOOT NUMBNESS. POST-OPERATIVE IMAGING STUDIES REPORTEDLY REVEALED THAT THE PATIENT HAD DEVELOPED UNCONTROLLED BONE GROWTH AND RESULTING RADICULOPATHY RELATED TO BONE OVERGROWTH AT OR NEAR THE SITE OF IMPLANT. A (B)(6) 2009 LUMBAR SPINE CT REPORTEDLY REVEALED ¿¿ LEFT POSTERIOR OSTEOPHYTE(S) DISPLACING THE LEFT ¿ NERVE ROOT(S)¿ AT LEVELS L4-S1. ON (B)(6) 2009, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE BONE OVERGROWTH IN HIS SPINE. THE REVISION SURGERY TO REMOVE BONEOVERGROWTH PROVIDED LIMITED RELIEF. THE PATIENT¿S CHRONIC PAIN SYMPTOMS REPORTEDLY RETURNED, AS WELL AS THE BONE OVERGROWTH. AN (B)(6) 2010, LUMBAR SPINE MRI REPORTEDLY REVEALED L4-S1 STENOSIS DUE TO ¿¿ HYPERTROPHIC CHANGES (AND) PROMINENT ENHANCING SCAR[RING]¿¿ AN (B)(6) 2012 LUMBAR SPINE MRI REPORTEDLY INDICATED ¿... RESIDUAL LEFT BONE FORAMINAL ENCROACHMENT¿ AT LEVELS L4-S1. ON (B)(6) 2012, THE PATIENT UNDERWENT A SECOND REVISION SURGERY TO REMOVE BONE OVERGROWTH. IN THE OPERATIVE NOTES, THE PHYSICIAN ALLEGEDLY OBSERVED THAT THE PATIENT ¿HAS RECURRENT STENOSIS OVER THE FORAMINA AT [LEVELS] 4-5 5-1. THIS IS DUE TO CALCIFIED DISK AND OVERGROWTH OF THE POSTEROLATERAL FUSION ¿¿ THE PATIENT NOW REPORTEDLY HAS SEVERE INJURIES, INCLUDING BUT NOT LIMITED TO BONE OVERGROWTH CAUSING CHRONIC RADICULOPATHY, CHRONIC PAIN, SHOOTING AND BURNING PAIN IN HIS LEFT LEG, LEFT FOOT NUMBNESS, AND RETROGRADE EJACULATION. EVEN AFTER THE REVISION SURGERIES, THE PATIENT REPORTEDLY CONTINUES TO EXPERIENCE SIGNIFICANT PAIN. AS A RESULT OF HIS ONGOING CHRONIC PAIN, THE PATIENT IS UNABLE TO SIT AND WORK FOR MORE THAN ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110605AAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention