BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 4261394 · Received November 19, 2014

    Report

    Report Number
    1030489-2014-04439
    Event Type
    Injury
    Date Received
    November 19, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART NUMBER OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART #S 75444545, 75445545, 7540020, 869-013, 811-322, 811-323, AND 75446545. (B)(6). 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 THE PATIENT HAD A MOTOR VEHICLE ACCIDENT ON (B)(6) 2008. ON (B)(6) 2009 : THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF DEGENERATIVE DISK DISEASE L2-3, L3-4, L4-5, AND LS-SI; LUMBAR STENOSIS FROM L3-5 IVITH SEVERE STENOSIS AT THESE LEVELS; HERNIATED NUCLEUS PULPOSUS CENTRALLY LS-S1; WORSENING LOW BACK PAIN AND LEFT LOWER EXTREMITY RADICULOPATHY; LEFT ULNAR NEUROPATHY AND LEFT CARPAL TUNNEL SYNDROME; NECK PAIN; LUMBAR SPONDYLOSIS L2-3, L3-4, L4-5 AND LS-S1. THE PATIENT UNDERWENT BILATERAL LAMINECTOMY WITH BILATERAL MEDIAL FACETECTOMIES AND BILATERAL TOTAL RADICAL DISKECTOMIES, L2-3, L3-4, L4-5 AND L5-S1 FOR NEURAL DECOMPRESSION; BILATERAL POSTERIOR LUMBAR INTERBODY FUSION L2-3, L3-4, L4-5, AND LS-SL UTILIZING NOVEL PEEK INTERBODY CAGES PACKED WITH MORCELLIZED AUTOGRAFT FROM THE SAME SKIN INCISION AND CANCELLOUS ALLOGRAFT BONE CHIPS; BILATERAL POSTERIOR LATERAL FUSION FROM L2 TO THE SACRUM UTILIZING INFUSE BONE MORPHOGENIC PROTEIN BONE GRAFT ALONG WITH MORCELLIZED AUTOGRAFT FROM THE SAME SKIN INCISION; BILATERAL PEDICLE SCREW PLACEMENT WITH SEGMENTAL FIXATION FROM L2 TO THE SACRUM UTILIZING DANEK LEGACY PEDICLE SCREW INSTRUMENTATION ALONG WITH CROSSLINK PLACEMENT AT L2-3 AND L4-5; A 360 DEGREE FUSION OF THE LUMBAR SPINE THROUGH THE SAME SKIN INCISION POSTERIORLY WHICH INVOLVES INTERBODY FUSION AND POSTERIOR LATERAL FUSION ALL DONE THROUGH THE SAME SKIN INCISION POSTERIORLY FROM 1.2 TO THE SACRUM BILATERALLY. AS PER OP NOTES, A BILATERAL NOVEL PEEK CAGE WAS PLACED AT EACH LEVEL ON BOTH SIDES FOR THE INTERBODY FUSION AND THESE CAGES WERE PACKED WITH MORCELLIZED AUTOGRAFT FROM THE SAME SKIN INCISION WHICH WAS FROM THE MIDLINE DECOMPRESSION BONE ALONG WITH SOME CANCELLOUS ALLOGRAFT BONE CHIPS AND SOME BLOOD FROM THE EPIDURAL SPACE WHICH WAS COLLECTED DURING THE PROCEDURE. ILIAC CREST BONE GRAFTING WAS NOT PERFORMED AFTER THE CAGE PLACEMENT AT EACH LEVEL. LATERAL FUSION WAS DONE BY PEDICLE SCREW PLACEMENT USING DANEK LEGACY PEDICLE SCREW INSTRUMENTATION. THE PEDICLE SCREWS THAT WERE PLACED WERE BILATERAL, THE PEDICLE SCREW PLACED AT L2 WAS 4.5 X 45 MM PEDICLE SCREW, AT L3 THEY WERE 4.5 X 45 MM AS WELL, AT L4 DOCTOR PLACED 5.5 X 45 MM PEDICLE SCREW, AT L5 DOCTOR PLACED 6.5 X 45 MM PEDICLE SCREWS AND THE SAME SCREWS WERE USED IN THE SACRUM BILATERALLY WHICH WERE 6.5 X 45 MM PEDICLE SCREWS AS WELL. ALL THE PEDICLE SCREWS PLACED WERE 45 MM. INTRAOPERATIVE EMG MONITORING WAS THEN PERFORMED. FINAL AP AND LATERAL FLUOROSCOPIC IMAGES. ABOUT 2 LITERS OF ANTIBIOTIC CONTAINING SOLUTION WAS USED TO IRRIGATE THE POSTERIOR LUMBAR WOUND. DOCTOR THEN EXPOSED THE LATERAL GUTTER AND OVER THE DECORTICATED BONE LATERALLY DOCTOR PLACED GENEROUS ROLLS OF INFUSE BONE MORPHOGENIC PROTEIN BONE GRAFT PACKED WITH MORCELLIZED AUTOGRAFT FROM THE SAME SKIN INCISION AND SOME CANCELLOUS ALLOGRAFT BONE CHIPS. A VERY GENEROUS SUPPLY OF BONE GRAFT WAS PLACED LATERALLY OVER THE DECORTICATED BONE AT L2, L3, L4, L5 AND S1 TO COMPLETE THE POSTERIOR LATERAL FUSION BILATERALLY FROM L2 TO THE SACRUM AND ESSENTIALLY COMPLETE A 360 DEGREE FUSION OF THE LUMBAR SPINE THROUGH THE SAME SKIN INCISION POSTERIORLY. ILIAC CREST BONE GRAFTING WAS NOT PERFORMED. EACH OF THE CAGES AND THE DISK SPACES WERE APPROPRIATELY POSITIONED IN THE DISK SPACE AND COUNTERSUNK TO AN EQUAL DEGREE IN THE DISK SPACE AT EACH LEVEL. THERE WAS NO MOTION AT ANY OF THE CAGES OF THE DISK SPACE AFTER COMPRESSION OF THE PEDICLE SCREWS PRIOR TO FINAL LOCK DOWN OF THE HARDWARE. DOCTOR DID USE TWO SEPARATE LARGE KITS OF INFUSE BONE MORPHOGENIC PROTEIN BONE GRAFT AND A LARGE KIT WAS USED EACH SIDE AND DIVIDED IN HALF AND COMBINED IN ROLLS TO PLACE OVER DECORTICATED BONE LATERALLY LATERAL TO THE HARDWARE AT EACH LEVEL. ON (B)(6) 2009: THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2009: ASSESSMENT: STATUS POST MULTI-LEVEL LAMINECTOMY/FUSION WITH PEDICLE SCREWS. 2. CHRONIC POSTOPERATIVE PAIN SYNDROME, NOW WITH, NEUROPATHIC SIGNS WITH A BURNING SENSATION. ON (B)(6) 2009 : THE PATIENT UNDERWENT CT SCAN OF LUMBAR SPINE. IMPRESSION: NEW MULTILEVEL POST SURGICAL CHANGES ARE SEEN; THERE IS A WELL DEFINED FRACTURE THROUGH THE POSTERIOR SUPERIOR CORNER OF L2 WITHOUT SIGNIFICANT RETROPULSION OR DISPLACEMENT. THIS FAILS TO PRODUCE SIGNIFICANT DEFORMITY OF THE THECAL SAC OR CENTRAL STENOSIS BUT MAY CONTRIBUTE TO THE PATIENT¿S RESIDUAL BACK PAIN; LUCENCY ABOUT THE TRANS PEDICULAR SCREWS BILATERALLY AT L2 IS SEEN RAISING THE POSSIBILITY OF LOOSENING OF THE SCREWS; LUCENCY ABOUT THE INTERBODY GRAFT AT L2-3 IS NOTED WORRISOME FOR INTERBODY FUSION FAILURE. THE REMAINING INTERBODY GRAFTS ARE IN GOOD POSITION AND THOSE FUSIONS APPEAR GROSSLY COMPLETE. THE PATIENT UNDERWENT LUMBAR MYELOGRAM. IMPRESSION: MULTILEVEL POST SURGICAL CHANGES FROM L2 THROUGH S1. SURGICAL HARDWARE APPEARS INTACT. INTERBODY GRAFTS ARE WELL LOCATED; NO OBVIOUS LUMBAR NERVE ROOT ABNORMALITY IS SEEN; THE POSSIBILITY OF A POSTOPERATIVE SEROMA SEEN WITHIN POSTERIOR PARASPINOUS SOFT TISSUES IS SUSPECT. ON (B)(6) 2009: THE PATIENT UNDERWENT MOTOR NERVE CONDUCTION STUDY: IMPRESSIONS: LEFT RADIAL SENSORY CONDUCTION STUDIES ARE NORMAL; THE LEFT MEDIAN SENSORY LATENCY IS MILDLY PROLONGED AT 2.4 MSEC, UPPER LIMIT 2.2 MSEC. MOTOR CONDUCTION STUDIES ARE NORMAL; THE LEFT ULNAR SENSORY LATENCY IS PROLONGED AT 2.5 MSEC, UPPER LIMIT 2.2 MSEC. THERE IS MILD SLOWING OF THE LEFT ULNAR NERVE ACROSS THE ELBOW AT 46 M/SEC, LOWER LIMIT 52 M.SEC; NEEDLE ELECTRODE EXAMINATION OF THE LEFT UPPER EXTREMITY AND CERVICAL PARASPINAL MUSCLES IS NORMAL. ON (B)(6) 2009: THE PATIENT PRESENTED WITH SEVERE PAIN AND A PERSISTING BURNING SENSATION THAT RADIATES INTO HIS BUTTOCKS. ASSESSMENT: MULTI-LEVEL DECOMPRESSION/FUSION FROM L2 THROUGH THE SACRUM WITH PERSISTENT AND CHRONIC DEVELOPING PAIN WITH NEUROPATHIC PROCESS. ON (B)(6) 2009: THE PATIENT PRESENTED WITH COMPLAINING OF SEVERE LOWER BACK PAIN. ASSESSMENT: STATUS POST MULTI-LEVEL FUSION/DECOMPRESSIVE LAMINECTOMY WITH SIGNIFICANT POSTOP ISSUES INCLUDING POSTOP NEUROPATHY, NEURALGIA AND PAIN. THE PATIENT¿S MEDICATION NEURONTIN WAS DECREASED TO 200 MG. ON (B)(6) 2009: THE PATIENT PRESENTED WITH COMPLAINING OF BACK PAIN WITH RADIATION INTO BUTTOCKS. ASSESSMENT: FAILED BACK SYNDROME, IN NEED OF HARDWARE REMOVAL ONCE BONE REGROWTH HAS OCCURRED. CHRONIC PAIN SYNDROME. ON (B)(6) 2009: THE PRESENTED WITH THE FOLLOWING PRE-OPERATIVE DIAGNOSES: SACROILIAC JOINT ARTHROPATHY IN A BILATERAL FASHION. 2. O OSTEOARTHRITIS OF THE LEFT KNEE. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: SACROILIAC JOINT INJECTIONS, BILATERAL. LEFT-SIDED KNEE JOINT INJECTION. FLUOROSCOPIC UTILIZATION FOR APPROPRIATE NEEDLE POSITIONING AND INTERPRETATION. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2009: THE PRESENTED WITH THE FOLLOWING PRE-OPERATIVE DIAGNOSES: BURSITIS NOT OTHERWISE SPECIFIED. POST LAMINECTOMY SYNDROME OF THE LUMBAR SPINE. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: BURSA INJECTION INTO THE PATIENT'S PAINFUL BURSITIS OVERLYING EACH PEDICLE SCREW INSERTION SITE (A TOTAL OF SIX BURSAE WERE INJECTED, THREE ON EACH SIDE). FLUOROSCOPIC UTILIZATION FOR APPROPRIATE NEEDLE POSITIONING AND INTERPRETATION. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2010: THE PATIENT PRESENTED WITH COMPLAINING OF CHRONIC BACK PAIN. THE PATIENT HAS BEEN UNDER EXTENSIVE THERAPY. ASSESSMENT: ACUTE BRONCHITIS. PERSISTENT BACK PAIN FOLLOWING EXTENSIVE BACK SURGERY. ON (B)(6) 2010 : THE PATIENT PRESENTED WITH PREOP DIAGNOSIS OF PAINFUL RETAINED LUMBAR HARDWARE BILATERALLY FROM L2 TO THE SACRUM, WHICH IS DANEK LEGACY PEDICLE SCREW INSTRUMENTATION; LEFT ULNAR NEUROPATHY AND LEFT CARPAL TUNNEL SYNDROME; PERSISTENT SEVERE LOWER BACK PAIN AFTER LUMBAR FUSION FROM L2 TO THE SACRUM POSTERIORLY; SOLID ARTHRODESIS, L3-4, L4-5 AND L5-S1 WITH POSSIBLE PSEUDARTHROSIS OFL2-3. THE PATIENT UNDERWENT EXPLORATION OF POSTERIOR LUMBAR FUSION FROM L2 TO THE SACRUM BILATERALLY; EXPLORATION AND REMOVAL OF LUMBAR PEDICLE SCREW INSTRUMENTATION BILATERALLY FROM L2 TO THE SACRUM, WHICH IS REMOVAL OF DANEK LEGACY PEDICLE SCREW INSTRUMENTATION SYSTEM AND CROSS LINK REMOVAL. RE-DO POSTER LATERAL FUSION, L2-3, USING INFUSE BONE MORPHOGENIC PROTEIN BONE GRAFT ALONG WITH CANCELLOUS ALLOGRAFT BONE CHIPS AND MORSELIZED AUTOGRAFT IN SAME SKIN INCISION; RE-DO PEDICLE SCREW PLACEMENT, L2-3 , USING DANEK LEGACY PEDICLE SCREW INSTRUMENTATION SYSTEM ALONG WITH CROSSLINK PLACEMENT AGAIN AT L2-3 POSTERIORLY; HARVESTING OF MORSELIZED AUTOGRAFT FROM THE SAME SKIN INCISION FOR THE RE-DO POSTEROLATERAL FUSION, L2-3; INTRAOPERATIVE AP AND LATERAL FLUOROSCOPY FOR LEVEL LOCALIZATION AND CONFIRMATION OF HARDWARE REMOVAL AND HARDWARE PLACEMENT AT L2-3 AGAIN. AS PER OP NOTES, THE PEDICLE SCREWS WERE LOOSE AT L2 SIGNIFICANTLY. AFTER PEDICLE SCREWS INSTRUMENTATION WAS REMOVED IT WAS NOTICED THAT THE FUSION WAS NOT HEALED AT L2-3. DOCTOR USED A LARGE KIT OF INFUSE BONE MORPHOGENIC BONE GRAFT COMBINED WITH SOME MORSELIZED AUTOGRAFT, WHICH HAS BEEN HARVESTED FROM SOME MIDLINE BONE ALONG WITH SOME CANCELLOUS ALLOGRAFT BONE CHIPS. THERE WAS SIGNIFICANT OSTEOLYSIS AROUND THE PEDICLE SCREWS AT L2 AND DOCTOR DID HAVE TO USE MUCH LARGER PEDICLE SCREWS AT L2. THE PEDICLE SCREWS THAT HAD BEEN PLACED PREVIOUSLY AT L2 WERE 4.5-MM SCREWS AND DOC TOR HAD TO USE 7.5-MM SCREWS AT L2 TO OBTAIN PURCHASE. THESE SCREWS HAD EXCELLENT PURCHASE THOUGH. DOCTOR WAS NOT ABLE TO ACHIEVE PURCHASE WITH 5.5- OR 6.5-MM SCREWS AT L2 AND HAD TO USE 7.5-MM SCREWS. THESE WERE 45 MM IN LENGTH. DOCTOR PLACED NEW PEDICLE SCREWS AT L3 AS WELL. THESE WERE PLACED DOWN THE OLD PEDICLE TRACTS AT L2 AND L3 WITH GOOD PURCHASE. DOCTOR USED 5.5 X 45-MM PEDICLE SCREWS AT L3 AND 7.5 X 45-MM PEDICLE SCREWS AT L2. AGAIN, THE OLD PEDICLE SCREWS THAT WERE REMOVED AT THESE LEVELS WERE 4.5 MM AND AGAIN. THE PEDICLE SCREWS WERE PLACED WITH LARGER PEDICLE SCREWS. THE PEDICLE SCREWS WERE LINED UP AND RODS WERE PLACED BETWEEN THE PEDICLE SCREW HEADS. THE RODS WERE LOCKED INTO POSITION WITH SET SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751754 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention