BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5044121 · Received September 1, 2015

    Report

    Report Number
    1030489-2015-02127
    Event Type
    Injury
    Date Received
    September 1, 2015
    Report Date
    August 3, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT UNDERWENT A CT SCAN FOR LUMBAR SPINE. IT WAS OBSERVED THAT THERE WAS LOSS OF DISC HEIGHT AT L4-LS AND LS-S1. THERE IS FACET DEGENERATIVE CHANGE AT L4-LS AND LS-SL. ON (B)(6) 2008 THE PATIENT WAS PRESENTED WITH CHRONIC LOW BACK AND LEFT LEG PAIN. FINDINGS SHOW TWO LEVELS OF MILD TO MODERATE INTERVERTEBRAL DISC DEGENERATION FROM L4 TO S1 WITH FACET DISEASE AND A NORMAL L3-4 DISC. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR AN OFFICE VISIT. IT WAS REPORTED THAT CHRONIC LOWER BACK AND LEFT LEG PAIN GRADUALLY WORSENING OVER THE COURSE OF SEVERAL YEARS. THE POSSIBILITY OF LYME'S DISEASE WAS ALSO OBSERVED. ON (B)(6) 2008 THE PATIENT PRESENTED WITH POSITIVE LYME'S DISEASE AFFECTING THE MUSCULOSKELETAL SYSTEM, NERVOUS SYSTEM OR CARDIOVASCULAR SYSTEM THAT IS LABORATORY CONFIRMED. ON (B)(6) 2008 THE PATIENT WAS PRESENTED WITH CHRONIC LOW BACK AND LEFT LEG PAIN THAT HAS GRADUALLY WORSENED. ON (B)(6) 2008 THE PATIENT WAS DIAGNOSED WITH 1) LUMBAR INTERVERTEBRAL DISC DEGENERATION AT L4-S, L5-S1; 2) LEFT IEG RADICULOPATHY; 3) LUMBAR HERNIATED NUCLEUS PULPOSUS L5-S1; 4) LOWER BACK PAIN. PROCEDURES PERFORMED WERE 1) ANTERIOR LUMBAR FUSION VIA INTERBODY TECHNIQUE, L4-LS, LS-S1; 2) INTERVERTEBRAL DEVICES PLACED AT L4-L5 AND L5-S1 USING MACHINED SPACERS; 3) POSTERIOR PEDICLE SCREW INSTRUMENTATION L4 TO S1 USING PEDICLE SCREW SYSTEM PER-OP NOTES, A 12-MM MACHINED SPACER WAS THEN SELECTED. A LARGE RH-BMP2/ACS KIT HAD BEEN RECONSTITUTED ON THE BACK TABLE. AFTER IRRIGATING, THEN PACKED TWO H-BMP2/ACS SPONGES INTO THE CENTER OF THE SPACER, AND THIS WAS THEN INSERTED VIA THE INSERTER INTO THE CENTER OF THE L4-5 DISC. OVERALL EXCELLENT ALIGNMENT, THE GRAFT WAS SLIGHTLY RECESSED FROM THE ANTERIOR CORTEX. THEN PLACED ONE ADDITIONAL RH-BMP2/ACS SPONGE TO THE LEFT OF THE SPACER. THE RETRACTORS WERE THEN MOVED TO EXPOSE THE L5-S1 DISC. THEN PERFORMED A BLOCK DISCECTOMY THERE AS WELL, REMOVING THE ANTERIOR ANNULUS AND THEN DISSECTING BACK TO THE POSTERIOR ANNULUS. THEN USED THE DILATORS AND THEN RASPS UP TO SIZE #12, AND THEN SELECTED A 12-MM MACHINED SPACER. PLACED RH-BMP2/ACS SPONGES INSIDE OF THE SPACE BEFORE IT WAS ADVANCED INTO THE CENTER OF THE L5-S1 DISC. AN ADDITIONAL RH-BMP2/ACS SPONGE WAS THEN PLACED LEFT OF THE SPACER. WE THEN CHECKED FOR BLEEDING WHICH WAS ABSENT. FINAL AP AND LATERAL X-RAYS WERE THEN TAKEN SHOWING THAT ALL INSTRUMENTS, AS WELL AS LAP PADS, WERE REMOVED. PERFORMED MULTIPLE ANTERIOR AND POSTERIOR FLUOROSCOPIC X-RAYS TO PROPERLY LOCALIZE THE PEDICLE SCREW INSTRUMENTATION AS WELL AS LOCALIZE THE POSITIONING OF THE INTERBODY IMPLANTS. THEN ENLARGED THE SKIN INCISIONS AND THEN PASSED DILATORS OVER THE GUIDEWIRES, TAPPED OVER THE GUIDEWIRES AND THEN PLACED 6.5-MM SEXTANT SCREWS MEASURING 45-MM AT L4 AND 35-MM AT S1. THEN ATTACHED THE TOP TOWERS ON THE TOPS OF THE SCREWS AND THEN USING THE SEXTANT DEVICE, MADE A SKIN INCISION AT THE MID LUMBAR SPINE AND THEN PASSED A 70-MM ROD THROUGH THE TOPS OF BOTH SCREWS. THEN PLACED TOP TIGHTENING NUTS, AND COMPRESSED ACROSS THE L4 TO S1 SCREWS. THIS WAS PERFORMED ON THE LEFT AND THE RIGHT. THEN REMOVED ALL INSTRUMENTS AND THEN AP AND LATERAL FLUOROSCOPIC X-RAYS SHOWED EXCELLENT POSITION OF THE PEDICLE SCREW INSTRUMENTATION AND INTERBODY GRAFTS. ON (B)(6) 2008 THE PATIENT PRESENTED WITH AN OFFICE VISIT FOR STATUS POST L4-S1 FUSION ON (B)(6) 2008. NO COMPLICATIONS WERE REPORTED. SHE UNDERWENT XRAYS OF AP AND LATERAL LUMBAR SPINE IN WHICH NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2009 THE PATIENT PRESENTED WITH AN OFFICE VISIT FOR STATUS POST L4-S1 FUSION ON (B)(6) 2008. NO COMPLICATIONS WERE REPORTED. SHE UNDERWENT XRAYS OF AP AND LATERAL LUMBAR SPINE IN WHICH NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2009 THE PATIENT UNDERWENT CT SCAN OF CERVICAL SPINE IN WHICH IT WAS OBSERVED THAT THERE WAS STRAIGHTENING AND REVERSAL OF THE CERVICAL LORDOSIS WITH SOME NARROWING OF THE DISC SPACE AT C4-5 AND C5-15 AND SLIGHT OSTEOPHYTE. ON (B)(6) 2009 THE PATIENT UNDERWENT MRI FOR CERVICAL SPINE. IMPRESSIONS OF MRI WERE : 1) DEGENERATIVE CHANGES WERE IDENTIFIED FROM C3-4 THROUGH C6- 7, AS DESCRIBED ABOVE, THERE WAS A CENTRAL AND LEFT SIDED DISC PROTRUSION AT C4-5 WHICH CONTACTS THE VENTRAL BORDER OF THE CERVICAL SPINAL CORD, MILD NARROWING OF THE THECAL SAC WAS SEEN AT C5-6. THERE WAS A SMALL RIGHT PARACENTRAL DISC PROTRUSION AT C6-7 WHICH CAUSED MILD NARROWING OF THE THECAL SAC AND NEAR EFFACEMENT OF THE VENTRAL SUBARACHNOID SPACE. 2) NEURAL FORAMINAL NARROWING WAS IDENTIFIED FROM C3-4 THROUGH C6-1 AS DESCRIBED ABOVE. 3) THERE WAS LOSS OR NORMAL CERVICAL LORDOSIS THERE WAS MILD RETROLISTHESIS OF C4 ON C5 WITH SLIGHT RETROLISTHESIS ON C5 ON C6. 4) DEGENERATIVE CHANGES WERE DESCRIBED AT THE C4-5 AND C5-6 LEVELS ON A PREVIOUS CT OF THE CERVICAL SPINE. REVERSAL OR THE CERVICAL LORDOSIS WAS ALSO SEEN ON THIS STUDY. THE PATIENT ALSO UNDERWENT MRI FOR LUMBAR SPINE IN WHICH IT WAS OBSERVED THAT 1) NEW POSTOPERATIVE CHANGES WERE IDENTIFIED STATUS POST FUSION OF THE L4 THROUGH S1 VERTEBRAL BODLES, THERE IS NO GROSS MALALIGNMENT OF THE LUMBAR VERTEBRAL BODIES. 2) A SMALL BROADBASED DISC BULGE IS NOTED AT L3-4. THERE WAS NO THECAL SAC COMPRESSION OR FOCAL DISC HERNIATION AT THE REMAINING LUMBAR LEVELS. 3) HYPERTROPHIC FACET ARTHROPATHY WAS SEEN FROM L3-4 THROUGH L5-S1. THE NEURAL FORAMINA ARE PATENT. ON (B)(6) 2010 THE PATIENT WAS ADMITTED DUE TO DIAGNOSIS OF C4-5 HERNIATED DISC. PATIENT UNDERWENT FOLLOWING PROCEDURE : C4-5 ANTERIOR CERVICAL DISCECTOMY AND FUSION EXTENSIVE DISCECTOMY, ARTHRODESIS C4-5, INTRUMENTATION C4-5, APPLICATION OF BIOMECHANICAL DEVICE C4-5, AND USE OF OPERATING MICROSCOPE. PER-OP NOTES, AN EXTENSIVE DISCECTOMY WAS PERFORMED AT C4-5 USING CURETTE INSTRUMENTS, THE MICROPITUITARY AND THE 2MM AND 1MM KERRISONS. THE RHOTON NERVE HOOK WAS THEN USED TO REMOVE FRAGMENTS OF DISC THE APPEARED TO BE HERNIATED TOWARDS THE LEFT C5 NERVE ROOT. TWO LARGE FRAGMENTS WERE REMOVED. THE INTERVERTEBRAL WAS IRRIGATED. HEMOSTASIS WAS VERIFIED. A 7MM*11MM*11MM GRAFT WAS PACKED WITH DBX AND PLACED WITHIN THE C4-5 INTERVERTEBRAL SPACE. THE DISTRACTION DEVICE WAS THEN DISENGAGED. A SIZE 25 PLATE WAS PLACED ACROSS THE C4-5 INTERVERTEBRAL SPACE. THIS WAS SECURED WITH FOUR 12MM SCREWS IN A STANDARD FASHION. A FINAL FLUOROSCOPY WAS THEN PERFORMED TO VERIFY THE CONSTRUCT. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577622 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