BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3085908 · Received April 30, 2013

    Report

    Report Number
    1030489-2013-01388
    Event Type
    Injury
    Date Received
    April 30, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    ON (B)(6) 2007, THE PATIENT UNDERWENT POSTERIOR CERVICAL DECOMPRESSIVE LAMINECTOMY, C3 THROUGH TL BILATERAL DECOMPRESSION OF SPINAL CANAL AND SPINAL NERVE ROOTS, POSTERIOR CEREBRAL ARTHRODESISF C3 THROUGH TL. POSTERIOR CERVICAL INSTRUMENTATION C3 THROUGH TL WITH STRYKER TITANIUM LATERAL MAST SCREW SYSTEM. POSTERIOR CERVICAL REDUCTION OF DEFORMITY, C4/C5, WITH APPLICATION OF ALLOGRAFT. STRYKER TITANIUM SCREW SYSTEM, BONE GRAFT HARVEST, MORCELLIZED BONE GRAFT COMBINED WITH RHBMP-2/ACS, APPLICATION OF ALLOGRAFT. SURGERY WAS TO TREAT CERVICAL SPONDYLOSIS, CERVICAL MYELOPATHY, CERVICAL DEGENERATIVE DISK DISEASE, CERVICAL DEFORMITY. X-RAY OF SPINE ON (B)(6) 2007: X-RAYS OBTAINED IN OPERATING ROOM. EXTENSIVE POSTERIOR SPINAL FUSION FROM C3 TO C7. OVERLYING SOFT T ISSUE. TWO SCREWS AT EACH LEVEL. FIVE VERTEBRAE CAN BE SEEN. LOWER CERVICAL SPINE IS OBSCURED BY SOFT TISSUE. PATIENT DISCHARGED ON (B)(6) 2007. (B)(6) 2008: X-RAY OF C-SPINE. IMAGES COMPARED WITH (B)(6) 2007 STUDY, EVIDENCE OF POSTERIOR CERVICAL FUSION WITH PEDICLE SCREWS AND ROD SYSTEM FROM C3 TO T1 APPEAR TO BE IN POSITION. (B)(6) 2008: X-RAY C-SPINE. THERE HAS BEEN NO INTERVAL CHANGE IN THE APPEARANCE OF THE CERVICAL SPINE SINCE THE PRIOR EXAM. LAMINECTOMY OF C3, C4, C5, C6 AND C7 HAS BEEN PERFORMED. POSITION AND APPEARANCE OF PEDICLE SCREWS AS WELL AS POSTERIOR STABILIZATION STRUTS APPEAR UNCHANGED. THERE IS NO EVIDENCE OF MALALIGNMENT OF INDIVIDUAL CERVICAL VERTEBRAL BODIES. ANTERIOR OSTEOPHYTE FORMATION ABOUT C3-4, C4-5, AND C5-6 IS EVIDENT AND IS ASSOCIATED WITH SOME SPURRING OF THE C6-7 INTERSPACE ANTERIORLY. THERE WAS NO EVIDENCE OF PREVERTEBRAL SOFT TISSUE SWELLING. STABLE APPEARANCE OF CERVICAL FUSION SINCE PRIOR EXAMINATION OF (B)(6) 2008. (B)(6) 2008: X-RAY C-SPINE. EXAM OF LATERAL CERVICAL SPINE. AP AND LATERAL RADIOGRAPHS OF THE CERVICAL SPINE WHEN COMPARED TO (B)(6) 2008 STUDY REVEAL NO INTERVAL CHANGE IN THE POSTERIOR CERVICAL FUSION OF C3 TO T1. ADVANCED ANTERIOR SPURRING AND LIPPING IS AGAIN NOTED. NO INTERVAL CHANGE IN THE OVERALL APPEARANCE OF THE POSTERIOR CERVICAL FUSION SINCE LAST STUDY. (B)(6) 2008: X-RAY C-SPINE. PATIENT HAS PAIN. METALLIC ROD FUSION, POSTERIOR APPROACH, SPANNING THE SPINE. ROD, SCREWS, PLATES MAINTAIN THEIR POSITION FROM C3 TO T1, SOFT TISSUE WITHIN NORMAL LIMITS. SPINE SPURS AS SEEN PREVIOUSLY. NO SIGNIFICANT CHANGES NOTED. (B)(6) 2008: X-RAY C-SPINE: POST-OP FUSION, IMAGES COMPARED WITH (B)(6) 2008 STUDY DEMONSTRATES DIFFUSION OF CERVICAL VERTEBRA WITH PEDICLE SCREWS AND RODS REMAIN IN ANATOMICAL POSITION AND ALIGNMENT. (B)(6) 2009: X-RAY C-SPINE, PATIENT HAS PAIN: INTERPRETATION: METALLIC ROD FUSION OVER 3-4-5-6-7-TI LEVE. DEGENERATIVE CHANGES THROUGHOUT CERVICAL SPINE WITH SPURS AT 4-5 LEVEL. DEGENERATIVE ENDPLATE AND LOSS OF DISC SPACE HEIGHT. PLATE, ROD, SCREWS MAINTAINED. (B)(6) 2009 CT C-SPINE WITH CONTRAST: POST-OP CHANGES CONSISTENT WITH METALLIC ROD FUSION POSTERIOR APPROACH SPANNING C3-T1 LEVELS. HARDWARE INTACT AND NOT LOOSE. VERTEBRAL BODY ALIGNED AND STABILE. NO LISTHESIS SEEN. DEGENERATIVE CERVICAL SPINE WITH LOSS OF DISC SPACE AND HEIGHT WITH VENTRAL SPURS THROUGHOUT. DEGENERATIVE CHANGES THROUGHOUT THE VERTEBRAL BODIES. (B)(6) 2009: CERVICAL SPINE MYELOGRAM CT 3-D IMAGING PATIENT HAS NUMBNESS AND PAIN IN ARMS: (B)(6) 2009 EKG (B)(6) 2009: STRESS TEST (B)(6) 2009: NM MYOCARD PERF SPECT MULT W/ CARD, EXAMINATION EXERCISE MYOCARDIAL PERFUSION (B)(6) 2009: RIGHT REVERSE SHOULDER TOTAL ARTHROPLASTY (PLATES AND SCREWS ZIMMER SYSTEM) DISCHARGED (B)(6) 2009. POST-OP X-RAYS SHOW NO EVIDENCE OF FRACTURES OR LOOSENING OF HARDWARE (B)(6) 2009: MEDICAL CONSULTATION FOR MANAGEMENT OF HYPERTENSION AND OTHER MEDICAL PROBLEMS POST RIGHT SHOULDER SURGERY. PHYSICAL EXAMINATION UNREMARKABLE WILL CONTINUE OUTPATIENT MEDS AND FOLLOW ORTHO DOCTORS' ORDERS (B)(6) 2009: ADMITTED TO HOSPITAL AFTER FALL AND SHOULDER DISLOCATION WITH CHIEF COMPLAINT, RIGHT SHOULD PAIN. CT AND X-RAYS OF SHOULDER DONE IN EMERGENCY ROOM (DO NOT SEE FRACTURE OR DISLOCATION), PATIENT ADMITTED FOR MONITORING, CONSULT ORTHO, PAIN MEDS GIVEN, ARM SPLINTED. DISCHARGED ON (B)(6) 2009. (B)(6) 2010: LEFT TOTAL KNEE ARTHROPLASTY, HOSPITAL 3 DAYS POST-OP, DISCHARGED ON (B)(6) 2010. (B)(6) 2011: MT SHOULDER TOTAL ARTHROPLASTY RIGHT , RIGHT REVISION REVERSE SHOULDER EXCHANGE POLY (B)(6) 2011: MAR HEAD W/O CONTRAST TO CHECK FOR POSSIBLE STROKE. FINDINGS: NO RESTRICTED DIFFUSION, INTRACRANIAL HEMORRHAGE, MASS EFFECT, MIDLINE SHIFT, OR AREA OF ABNORMAL ENHANCEMENT IS IDENTIFIED. CSF SPACES ARE SYMMETRIC. THE PATIENT IS STATUS POST POSTERIOR CERVICAL FUSION. THERE IS SLIGHT ANTERIOR DISPLACEMENT OF THE DENS ALMOST TO THE TIP OF THE CLIVUS. NO ACUTE INTRACRANIAL PROCESS. MILD MICROANGIOPATHY SEEN WITH GRAY MATTER CHANGES. NO ACUTE ISCHEMIC INTARCTION. (B)(6) 2011: MRI BRAIN WITH AND WITHOUT CONTRAST. THE PATIENT IS STATUS POST POSTERIOR CERVICAL FUSION. THERE IS SLIGHT ANTERIOR DISPLACEMENT OF THE DENS ALMOST TO THE TIP OF THE CLIVUS. NO CERVICAL TONSILIS IDENTIFIED. SMALL OVOID FOCUS OF DIFFERENTIAL TL SHORTENING IS SEEN WITHIN THE POSTERIOR NASOPHARYNX. THE PARANASAL SINUSES AND MASTOID AIR CELLS ARE CLEAR. ORBITS AND ORBITAL CONTENTS ARE UNREMARKABLE. (B)(6) 2012: CT HEAD WITH CONTRAST. HISTORY: LEFT CRANIOTOMY AND MIDDLE CEREBRAL ANEURYSM CLIP NOTED. NO ACUTE INTRACRANIAL HEMORRHAGE, MASS EFFECT OR MIDLINE SHIFT. NO ABNORMAL ENHANCEMENT. MAJOR INTRACRANIAL VESSELS ENHANCE NORMALLY HOWEVER, THERE IS LIMITED EVALUATION OF THE LEFT MIDDLE CEREBRAL ARTERY BRANCHES AT THE BIFURCATION OF THE LEFT MCA. THE SINUSES, ORBITS, ORBITAL CONTENTS AND MASTOID AIR CELLS ARE UNREMARKABLE. NO ACUTE PROCESS. POSTOPERATIVE CHANGES RELATED TO PRIOR LEFT MIDDLE CEREBRAL ARTERY ANEURYSM CLIPPING. (B)(6) 2013 - SURGERY ON RIGHT HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186042 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