BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4231773 · Received November 6, 2014

    Report

    Report Number
    1030489-2014-04252
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 9, 2014
    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)(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)-2002: THE PATIENT INJURED HERSELF WHILE TRANSFERRING A PATIENT WHILE AT WORK. (B)(6)-2002 : THE PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF A PAINFUL LEFT SACROILIAC. THE PATIENT UNDERWENT A LEFT SACROILIAC FUSION USING TITANIUM INTERPOSITION DEVICE, AND RHBMP-2/ACS. PER THE OP NOTES, THE RHBMP-2/ACS WAS MIXED AND A SMALL PLEDGET WAS PLACED BENEATH THE FUSION CAGE AND OVERLYING THE BONE. A 16MM CHANGE WAS USED AND THIS WAS REAMED TO 14MM, AND TAPED TO 14MM. A 16MM CAGE WAS THEN TORQUED INTO PLACE, AND THEN THE REMAINING RHBMP-2/ACS WAS PLACED WITHIN IT. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2004 : THE PATIENT PRESENTED WITH LOW BACK PAIN, LEFT GREATER THAN RIGHT, LEFT LEG PAIN RADIATES POSTERIORLY. ASSESSMENT: FACET JOINT ARTHROPATHY, POST SI JOINT FUSION; SACROILIAC JOINT DISEASE. (B)(6)-2004 : THE PATIENT UNDERWENT CT SCAN OF THE PELVIS. CONCLUSION: EXAMINATION SUGGESTS THERE IS A NON-DISPLACED STRESS FRACTURE OF THE LEFT ILIAC ADJACENT TO THE SI JOINTS ON AXIAL IMAGES 15 AND 16; THERE IS SOLID BONY ANKYLOSIS OF THE LEFT SI JOINT AND WITHOUT HARDWARE COMPLICATION; THERE IS MARKED ATROPHY OF THE GLUTEUS MEDIUS MUSCLE ON THE LEFT; PROBABLE SMALL BENIGN BONE ISLAND IN THE ANTEROMEDIAL ASPECT OF THE ACETABULUM ON THE RIGHT, OR COULD REPRESENT A BENIGN ENCHONDROME. (B)(6)-2005: THE PATIENT PRESENTED WITH LOW BACK PAIN AND STATUS POST SI JOINT FUSION. THE PATIENT UNDERWENT A FACET JOINT BLOCK L5-S1, DIAGNOSTIC, BILATERAL. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2005: THE PATIENT PRESENTED WITH LOW BACK PAIN. HER PREVIOUS INJECTION ONLY PROVIDED RELIEF FOR 3.5 HOURS. (B)(6)-2005: THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF LOW BACK PAIN AND TROCHANTERIC BURSITIS. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: PERCUTANEOUS RADIOFREQUENCY FACET NERVE ROOT BLOCK, L4, L5, S1, BILATERALLY; LEFT TROCHANTERIC BURSA INJECTION. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2005: THE PATIENT PRESENTED AFTER UNDERGOING MEDIAL BRANCH BLOCKS WITH NO RELIEF OF HER PAIN. (B)(6)-2005 : THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE DUE TO LOW BACK PAIN RADIATING DOWN THE LEFT LEG. CONCLUSION: STATUS POST LEFT SI JOINT FUSION USING METAL CAGEWHICH RESULT IN METAL BLOOMING ARTIFACT, BUT THE OPPOSITE SIDE IS INTACT INCLUDING THE VISUALIZED UPPER SACRUM; THE OVERALL BONE ALIGNMENT IS ANATOMIC WITHOUT DISC HERNIATION, BUT THERE IS FACET ARTHROPATHY WITH FLUID WITHIN THE JOINT SPACE ON THE RIGHT SIDE AT THE LUMBOSACRAL AREA. THERE IS ALSO MILD ARTHROPATHY AT L3-4. (B)(6)-2006: THE PATIENT PRESENTED WITH LOW BACK PAIN. THE PATIENT UNDERWENT A FACET JOINT BLOCK, L5-S1 BILATERALLY. (B)(6)-2007 : THE PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF PAINFUL DEGENERATIVE ARTHRITIS OF THE FACET JOINTS L5-S1. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: POSTEROLATERAL FUSION L5-S1; AUTOLOGOUS BONE GRAFT HARVESTED FROM THE RIGHT ILIAC CREST FROM A SEPARATE FASCIAL INCISION. PER THE OP NOTES, THE FACET JOINT OF L5-S1 WAS MARKEDLY ENLARGED. THERE WAS CALCIFICATION OF THE CAPSULE. THERE WAS A SYNOVIAL CYST. THERE WAS ACTUALLY A LARGE AMOUNT OF SYNOVIAL FLUID THAT WAS EVACUATED FROM THE FACET JOINT ITSELF. THAT PORTION OF THE INCISION WAS PACKED AND A SEPARATE INCISION WAS THEN MADE TO HARVEST BONE FROM THE RIGHT ILIAC CREST. FOLLOWING DECORTICATION OF THE TRANSVERSE PROCESSES OF L5 AND S1. A MEDIUM DOSE OF RHBMP-2/ACS WAS USED COMBINED WITH HER AUTOLOGOUS BONE. A LAYER OF RHBMP-2/ACS WAS LAID DOWN ON THE RAW BONE AND A LAYER OF AUTOLOGOUS BONE, THEN ANOTHER LAYER OF RHBMP-2/ACS AND ANOTHER LAYER OF AUTOLOGOUS BONE. (B)(6)-2007: THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE DUE TO LOW BACK PAIN. IMPRESSION: ORTHOPEDIC HARDWARE OVERLYING THE LEFT ASPECT OF THE SACRUM; MILD DEGENERATIVE CHANGES OF THE DISCS. (B)(6)-2007 : THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE WITHOUT CONTRAST DUE TO LOW BACK PAIN. CONCLUSION: POSTOPERATIVE CHANGES OF DECOMPRESSIVE LAMINECTOMY AND PARTIAL BILATERAL FACETECTOMIES AT L5-S1 WITH BONY DORSOLATERAL FUSION BILATERALLY AT L5-S1, MULTILEVEL DEGENERATIVE DISC DISEASE; NO RESIDUAL CENTRAL SPINAL CANAL OR SUBARTICULAR RECESS NARROWING AT L5-S1; ONGOING HEALING OF THE BILATERAL DORSOLATERAL BONY FUSION MASSES AT L5-S1; UNCHANGED 1-2 MM AP DIAMETER POSTERIOR MIDLINE TO LEFT PARACENTRAL DISC PROTRUSION AT L4-5 WITH RESULTANT MILD TO MODERATE LEFT SUBARTICULAR RECESS NARROWING, BUT NO SIGNIFICANT CENTRAL SPINAL CANAL STENOSIS; CHRONIC FORAMINAL NARROWING, MILD ON THE RIGHT AT L5-S1 AND MILD BILATERALLY AT L4-5 WITHOUT EXITING GANGLIONIC IMPINGEMENT; SOLID APPEARING LEFT SACROILIAC JOINT FUSION. (B)(6)-2007 : THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE DUE TO LOW BACK PAIN. IMPRESSION: ORTHOPEDIC HARDWARE ALONG THE LEFT ASPECT OF THE SACRUM WITHOUT CHANGE; MILD DEGENERATIVE CHANGES OF THE DISCS. (B)(6)-2008: THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF LOW BACK PAIN AND STATUS POST SPINAL FUSION. THE PATIENT UNDERWENT A FACET JOINT BLOCK, L4-5. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2008: THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE DUE TO BACK AND BILATERAL BUTTOCK AND SI JOINT REGION PAIN. CONCLUSION: SOLID LEFT SI JOINT FUSION; NO SOLID DORSAL FUSION AT L4-5 OR L5-S1 WITH FRAGMENTED INCOMPLETE DORSOLATERAL FUSION BONE MATERIAL; NO DISC HERNIATION OR CENTRAL STENOSIS IDENTIFIED. (B)(6)-2008 : THE PATIENT PRESENTED WITH THE FOLLOWING PREOPERATIVE DIAGNOSES: PAINFUL DEGENERATIVE DISC DISEASE AND FACET ARTHROPATHY L4-5, L5-S1; PSEUDOARTHROSIS L5-S1 OF PREVIOUS POSTERIOR FUSION L5-S1. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR INTERBODY FUSION L5-S1, L4-5, WITH PYRAMID LORODTIC INTERBODY CAGE L5-S1 WITH RHBMP-2/ACS; ANTERIOR PLATE FIXATION L5-S1 WITH PYRAMID PLATE; SYNFIX LORDOTIC INTERBODY CAGE, ENDPLATE L4-5 WITH RHBMP-2/ACS , 17 MM SYNFIX WITH 12 DEGREES OF LORDOSIS AND 16 MM PYRAMID WITH 12 DEGREES OF LORDOSIS. PER THE OP NOTES, AT L5-S1, THE ACTUAL IMPLANTS 16 MM LARGE FOOTPRINT 12 DEGREE LORDOSIS WAS FILLED WITH RHBMP-2/ACS AND MASTERGRAFT. ADDITIONAL RHBMP-2/ACS AND MASTERGRAFT AND DBX WERE PLACED POSTERIOR TO THE IMPLANT. THE IMPLANT WAS INSERTED USING A CATALYST INSERTER TO MINIMIZE TRAUMA TO THE IMPLANT AND BONE. AT L4-5, THE LARGE IMPLANT WAS FILLED WITH THE REMAINDER OF THE RHBMP-2/ACS ALONG WITH MASTERGRAFT AND DBX PUTTY. IMPLANT WAS INSERTED AND THEN THE PLATE FIXATION WAS TIGHTENED SECURELY USING FOUR 20 MM SCREWS. NO PATIENT COMPLICATIONS WERE NOTED. 03-AUG-2008: THE PATIENT WAS DISCHARGED HOME. (B)(6)-2009 : THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE L4-S1 TO EVALUATE FUSION. IMPRESSION: SOLID L5-S1 ANTERIOR AND POSTERIOR FUSION WITHOUT INSTRUMENTATION COMPLICATIONS, NO EVIDENCE OF RECURRENT SPINAL STENOSIS; THE L4-5 INTERBODY FUSION IS NOT SOLID AS THERE IS GAS INTERPOSED BETWEEN ENDPLATE AND GRAFT AS WELL AS THROUGH SUPERIOR BONE GRAFT, NO EVIDENCE OF ANY SOLID DORSAL FUSION WITH MODERATELY ADVANCED LEFT L4-5 FACET JOINT DEGENERATION; L4-5 AT LEAST MILD CENTRAL SPINAL STENOSIS WITH THICKENED LIGAMENTA FLAVA AND ANNULAR BULGING, DISC BULGING EXTENDS INTO EACH NERVE ROOT CANAL MORE PROMINENT ON THE LEFT CONTACTING UNDERSURFACE LEFT L4 GANGLION; NO EVIDENCE OF INSTRUMENTATION LOOSENING OR FATIGUE. (B)(6)-2009: THE PATIENT UNDERWENT X-RAYS OF THE SACRUM AND COCCYX DUE TO COCCYDYNIA. IMPRESSION: POSTOPERATIVE CHANGES INVOLVING THE LUMBOSACRAL SPINE WITH ORTHOPEDIC HARDWARE IN PLACE; NEGATIVE SACRUM AND COCCYX. (B)(6)-2009: THE PATIENT PRESENTED WITH A DIAGNOSIS OF COCCYODYNIA AND UNDERWENT A COCCYX INJECTION. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2009 : THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE WITHOUT CONTRAST DUE TO SPINE PAIN. IMPRESSION: POST-OPERATIVE CHANGES R EFLECTING ANTERIOR SPINAL FUSION L4-5 AND L5-S1 WITH SOLID FUSION AT L5-S1 BUT LUCENCY AND INCOMPLETE BONY BRIDGING AT L4-5, NO OBVIOUS HARDWARE COMPLICATION, SOLID FUSION OF THE LEFT SI JOINT NOTED, LEFT L4-5 NEURAL FORAMINAL NARROWING WITH IMPINGEMENT OF EXITING LEFT L4 NERVE ROOT. (B)(6)-2009: THE PATIENT UNDERWENT MRI OF THE CERVICAL SPINE DUE TO NECK PAIN WITH BILATERAL HAND NUMBNESS AND BILATERAL SHOULDER PAIN. CONCLUSION: SINGLE LEVEL FINDINGS AT C5-6 WHERE THERE IS KYPHOSIS AND AN ANNULAR FISSURE AND SLIGHT BULGE TO THE LEFT OF MIDLINE WITHOUT HERNIATION OR NEURAL CONTACT, REMAINING CERVICAL LEVELS ARE UNREMARKABLE. (B)(6)-2009: THE PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF CERVICAL SPONDYLOSIS. THE PATIENT UNDERWENT A BILATERAL C5-6 AND C6-7 FACET JOINT INJECTIONS. NO PATIENT COMPLICATIONSWERE NOTED. (B)(6)-2009: THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF NECK PAIN AND COCCYDYNIA. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: FLUOROSCOPICALLY GUIDED CONTRAST CONTROLLED BILATERAL C5-6-7 MEDIAL BRANCH ANESTHETIC BLOCKADE; FLUOROSCOPICALLY GUIDED CONTRAST CONTROLLED COCCYGEAL REGION INJECTION WITH SEDATION. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2009: THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF NECK PAIN/CERVICALGIA, CERVICAL RADICULAR PAIN, AND CERVICAL SPONDYLOSIS. THE PATIENT UNDERWENT A LEFT C5-7 RF NEUROTOMY. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2009: THE PATIENT PRESENTED FOR AN OFFICE VISIT. DIAGNOSIS: PSEUDOARTHROSIS OF L4-5 FUSION. (B)(6)-2009: THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF NECK PAIN/CERVICALGIA AND CERVICAL SPONDYLOSIS. THE PATIENT UNDERWENT A RIGHT C5-7 RF NEUROTOMY. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2009: THE PATIENT PRESENTED WITH NECK PAIN AND INTERMITTENT NUMBNESS AND TINGLING IN BOTH HANDS AS WELL AS WEAKNESS. THE PATIENT UNDERWENT NERVE CONDUCTION STUDIES. IMPRESSION: THIS IS A NORMAL ELECTRODIAGNOSTIC EXAMINATION OF THE BILATERAL UPPER EXTREMITIES. THERE IS NO DEFINITE EVIDENCE FOR RESIDUAL OR RECURRENT CARPAL TUNNEL SYNDROME, OTHER FOCAL OR GENERALIZED PERIPHERAL NEUROPATHY, BRACHIAL PLEXOPATHY ORCERVICAL RADICULOPATHIC CHANGES IN EITHER UPPER EXTREMITY. (B)(6)-2010: THE PATIENT UNDERWENT MRI OF THE THORACIC SPINE DUE TO NECK AND UPPER BACK PAIN WITH BILATERAL SHOULDER PAIN AND ALSO PAIN AND NUMBNESS IN HANDS. CONCLUSION: MILD TO MODERATE DIFFUSE THORACIC SPONDYLOSIS WITH A MILD THORACIC SCOLIOSIS; NO DISC HERNIATION OR FACET ARTHROPATHY AND NO STENOSIS OR IMPINGEMENT; NO INTRINSIC CORD LESION AND NO CORD EDEMA OR MYELOMALACIA; NO OSSEOUS OR PARASPINOUS NEOPLASM OR INFECTION. THE PATIENT ALSO UNDERWENT X-RAYS OF THE THORACIC SPINE. CONCLUSION: REVERSE CERVICAL LORDOSIS FROM C5-C7 WITHOUT DISC SPACE NARROWING, THERE IS AN ANTERIOR OSTEOPHYTE FROM THE ANTEROINFERIOR MARGIN OF THE C6 VERTEBRAL BODY; THE ANTERIOR ALIGNMENT IS NORMAL. (B)(6)-2010: THE PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF THORACIC PAIN. THE PATIENT UNDERWENT A FLUOROSCOPICALLY GUIDED CONTRAST CONTROLLED BILATERAL T3-4/4-5 FACET JOINT INJECTION. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2010 : THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE DUE TO LOW BACK PAIN AND NUMBNESS IN THE RIGHT LOWER EXTREMITY. CONCLUSION: SOLID 360 DEGREE INSTRUMENTED L5-S1 AND LEFT SACROILIAC JOINT FUSION, NO RESIDUAL OR RECURRENT CENTRAL OR FORAMINAL COMPROMISE; FAILED INTERBODY AND DORSOLATERAL L4-5 FUSION WITH EVIDENCE OF MOTION, MILD TO MODERATE CENTRAL AND MODERATELY SEVERE LEFT FORAMINAL STENOSIS WITH LEFT L4 IMPINGEMENT; NORMAL OR NEAR NORMAL L3-4 AND NORMAL L2-3 AND L1 TO ANNULAR MORPHOLOGY WITH MULTILEVEL FACET DEGENERATION; MODERATE RIGHT SACROILIAC JOINT DEGENERATION; IN COMPARISON TO 2009 CT, THERE HAS BEEN PROGRESSION OF FACET DEGENERATION LEFT L3-4 AND EQUIVOCAL SLIGHT PROGRESSION OF LEFT L4-5 FORAMINAL STENOSIS. (B)(6)-2010: AN OFFICE VISIT NOTE STATES THE PATIENT CONTINUES TO HAVE PSEUDOARTHROSIS AT L4-5 WITH DEFINITE LUCENCY AROUND THE SCREWS OF THE ANTERIOR INTERBODY DEVICE WHICH IS A SYNFIX DEVICE. (B)(6)-2010: THE PATIENT PRESENTED WITH UPPER THORACIC PAIN. (B)(6)-2010: THE PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF THORACIC PAIN. THE PATIENT UNDERWENT A FLUOROSCOPICALLY GUIDED CONTRAST CONTROLLED BILATERAL T3-4 AND T4-5 FACET JOINT INJECTION. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2011 : THE PATIENT PRESENTED WITH THE FOLLOWING PREOPERATIVE DIAGNOSES: PSEUDOARTHROSIS OF ANTERIOR INTERBODY FUSION, L4-5; CENTRAL AND FORAMINAL STENOSIS, L4-5 BILATERALLY, WITH RADICULOPATHY SECONDARY TO SUBSIDENCE OF ANTERIOR INTERBODY GRAFT AT L4-5; PREVIOUS ANTERIOR-POSTERIOR FUSION OF THE L5-S1 LEVEL. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: POSTEROLATERAL FUSION L4-5; BILATERAL LAMINOTOMY, MEDIAL FACETECTOMY, AND COMPLETE FORAMINOTOMY, L4-5 WITH DECOMPRESSION OF CENTRAL AND FORAMINAL STENOSIS; NON-SEGMENTAL INTERLAMINAR FIXATION, L4-5, USING COFLEX-F IMPLANT, BONE GRAFT SOURCE: ALLOSTEM BONE GRAFT, PLUS RHBMP-2/ACS MEDIUM DOSE. PER THE OP NOTES, ONCE THE L4-5 LEVEL HAD BEEN EXPOSED JUST DIRECTLY OPPOSITE THE LAMINA OF L3, THE TRANSVERSE PROCESS OF L4, AND THE FUSION MASS AT L5-S1 WAS IDENTIFIED AND EXPOSED. ONCE IT WAS EXPOSED ON THE RIGHT SIDE, I DECORTICATED AND PLACED A LAYER OF RHBMP-2/ACS, A LAYER OF ALLOSTEM BONE GRAFT, AND ANOTHER LAYER OF RHBMP-2/ACS. THIS WAS THEN PACKED OFF FOR THE REMAINDER OF THE PROCEDURE . ON THE LEFT SIDE, THE SAME PROCESS WAS ACCOMPLISHED. DURING THE BILATERAL LAMINOTOMY, MEDIAL FACETECTOMY, AND BILATERAL FORAMINOTOMY, THE TWO LAMINA OF L4 AND L5 WERE ALMOST TOUCHING EACH OTHER. HALF OF THE LAMINA OF L5 AND A 3RD OF THE LAMINA OF L4 HAD TO BE REMOVED. THE DOCTOR THEN REMOVED THE THICKENED BUCKLED HYPERTROPHIC LIGAMENTUM FLAVUM. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2011: THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE DUE TO LOW BACK PAIN. IMPRESSION: NO INTERVAL CHANGE FROM (B)(6)-2008 WITH POSTSURGICAL CHANGES AT L4-5 AND L5-S1 LEVELS AND LEFT SACROILIAC JOINT LEVEL. (B)(6)-2011: THE PATIENT PRESENTED WITH NECK PAIN, DIZZINESS, LIMITED CERVICAL RANGE OF MOTION, AND INTERSCAPULAR PAIN. IMPRESSION: PROGRESSIVE NECK PAIN WITH LIMITATION TO RANGE OF MOTION AND RADIATION TO THE INTERSCAPULAR REGION; LUMBAR AND THORACIC FACET ARTHROPATHY. (B)(6)-2011: THE PATIENT UNDERWENT X-RAYS OF THE CERVICAL SPINE. CONCLUSION: THERE IS MILD REVERSAL OF THE NORMAL CERVICAL LORDOTIC CURVE BUT THE ALIGNMENT IS ANATOMIC INCLUDING ATLANTOAXIAL RELATIONSHIP AND WITHOUT RADIOGRAPHIC EVIDENCE FOR DYNAMIC INSTABILITY; THERE MAY BE AN OLD AVULSION FRACTURE BETWEEN C6 AND C7 ANTERIORLY. THE PATIENT UNDERWENT MRI OF THE CERVICAL SPINE. CONCLUSION: MILD TO MODERATE C5-6 DISC DEGENERATION AND LEFT POSTEROLATERAL DISC HERNIATION WITH LEFT VENTRAL LATERAL CORD IMPINGEMENT AND ENCROACHMENT OR MILD IMPINGEMENT OF CISTERNAL C6 AND C7 ROOTLETS; MINIMAL C6-7 DISC DEGENERATION AND ANNULAR BULGING WITHOUT NEURAL COMPROMISE; OTHERWISE NORMAL CERVICAL AND UPPER THORACIC DISC MORPHOLOGY WITH MILD REVERSAL OF CERVICAL LORDOSIS AND CERVICAL THORACIC SCOLIOSIS; IN COMPARISON TO PRIOR STUDY THERE HAS BEEN PROGRESSION OF DISC DEGENERATION WITH DEVELOPMENT OF C5-6 DISC HERNIATION. (B)(6)-2011: THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF NECK PAIN/CERVICALGIA, CERVICAL RADICULAR PAIN AND CERVICAL SPONDYLOSIS. THE PATIENT UNDERWENT A C7-T1 INTERLAMINAR EPIDURAL STEROID INJECTION. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2011: THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF NECK PAIN, CERVICAL SPONDYLOSIS, AND DISC PROTRUSION. THE PATIENT UNDERWENT A FLUOROCOPICALLY GUIDED CONTRAST CONTROLLED BILATERAL C4,5,6 MEDIAL BRANCH ANESTHETIC BLOCKADE. (B)(6)-2011: THE PATIENT PRESENTED WITH NECK PAIN, CERVICALGIA, CERVICAL SPONDYLOSIS AND HEADACHE. THE PATIENT UNDERWENT A BILATERAL C4, C5, C6 MEDIAL BRANCH BLOCK. NO PATIENT COMPLICATIONS WERE NOTED. 29-NOV-2011: THE PATIENT PRESENTED WITH NECK PAIN, CERVICAL SPONDYLOSIS, AND FACET ARTHROPATHY. THE PATIENT UNDERWENT FLUOROSCOPICALLY GUIDED STIMULUS CONTROLLED RIGHT C4, C5, C6 MEDIAL BRANCH RF NEUROTOMY. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2011 : THE PATIENT UNDERWENT A CT OF THE LUMBAR SPINE. CONCLUSION: SOLID INTERBODY FUSIONS AT L4-5 AND L5-S1, SOLID L5-S1 DOR SAL FUSION AND INTACT INSTRUMENTATION, ALSO SOLID LEFT SI JOINT ARTHRODESIS; INTERSPINOUS PROCESS DEVICE AT L4-5 IS INTACT WITHOUT COMPLICATIONS, NO RECURRENT BONY CENTRAL STENOSIS AT THE POSTOPERATIVE LEVELS; RESIDUAL CHRONIC SEVERE LEFT AND MODERATE RIGHT L4-5 FORAMINAL STENOSIS, NO FRACTURES ARE IDENTIFIED; FACET JOINT DEGENERATION AT L3-4 AND L2-3 AS REPORTED. (B)(6)-2012: THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF THORACIC PAIN, SPONDYLOSIS, AND FACET ARTHROPATHY. THE PATIENT UNDERWENT A FLUOROSCOPICALLY GUIDED CONTRAST CONTROLLED BILATERAL T3-4, T4-5 FACET JOINT INJECTION. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6)-2012: THE PATIENT PRESENTED WITH INTERSCAPULAR CATCHING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714583 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