INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-03043
- Event Type
- Injury
- Date Received
- July 7, 2014
- Report Date
- July 27, 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
- ATTORNEY
Narratives
(B)(4).
(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.
IT WAS REPORTED THAT ON (B)(6) 2007 PATIENT PRESENTED WITH LOW BACK PAIN WITH LEFT LEG PAIN. FLEXION-EXTENSION VIEWS SHOW MOTION AT L4-5, AND PATIENT HAS ¿PRETTY SIGNIFICANT SPINAL STENOSIS AT L3-L4 WITH DEGENERATIVE DISC AT L3-L4.¿ ON (B)(6) 2007 PATIENT PRESENTED WITH PSEUDOARTHROSIS L5-S1 WITH SPINAL STENOSIS AND INSTABILITY OF L3-4. THE PATIENT UNDERWENT POSTEROLATERAL FUSION L3-S1 AND IMPLANTATION OF AN EBI STIMULATOR. POSTERIOR INSTRUMENTATION AND RHBMP-2/ACS WERE USED. ON (B)(6) 2007, PATIENT PRESENTED FOR POST-OP FOLLOW UP. ¿PLAIN X-RAYS SHOW THE ROD AND SCREW DEVICE IS IN GOOD POSITION. BONE GRAFT IS INCORPORATING.¿ ON (B)(6) 2007, PATIENT PRESENTED WITH CERVICAL DEGENERATIVE DISC DISEASE. PATIENT UNDERWENT EPIDURAL STEROID INJECTION C6-7. ON (B)(6) 2007 PATIENT PRESENTED FOR FOLLOW UP. ESI DID NOT HELP HER SYMPTOMS. IMPRESSION: STATUS POST CERVICAL FUSION WITH NEW HERNIATION AND STENOSIS WITH RADICULOPATHY. DECOMPRESSION AND FUSION WITH PLATING WAS PLANNED. ON (B)(6) 2007 THE PATIENT PRESENTED WITH HNP AT C6-7. PATIENT UNDERWENT ACDF C6-7 USING A CORNERSTONE PEEK INTERBODY SPACER, DMX, AND ATLANTIS ANTERIOR PLATING. ON (B)(6) 2007 PATIENT PRESENTED FOR POST-OP FOLLOW UP WITH COMPLAINTS OF LEFT LEG PAIN. PATIENT HAD A POSITIVE STRAIGHT LEG RAISE. ON (B)(6) 2007 MEDICAL RECORDS STATE ¿HER MRI SHOWS SOME STENOSIS ABOVE THE LEVEL OF HER FUSION, BUT OVERALL EVERYTHING LOOKS GOOD.¿ ON (B)(6) 2007 THE PATIENT PRESENTED WITH LUMBAR STENOSIS L1-2 WITH INSTABILITY STATUS POST POSTERIOR FUSION. PATIENT UNDERWENT POSTERIOR FUSION L1-2 AND REMOVAL OF HARDWARE L2-5 USING RHBMP-2/ACS. ON (B)(6) 2007 PATIENT PRESENTS FOR POST-OP FOLLOW UP. ¿X-RAYS SHOW THE ROD AND SCREW DEVICE IS IN GOOD POSITION. EVERYTHING IS WELL ALIGNED. GOOD BONE GRAFT IS FORMING IN THE POSTEROLATERAL GUTTER.¿ ON (B)(6) 2007 PATIENT PRESENTED FOR POST-OP FOLLOWUP. ¿X-RAYS OF THE LUMBAR SPINE SHOW THE ROD AND SCREWS IN GOOD POSITION. GONE GRAFT IS FORMING IN THE LATERAL GUTTERS. EVERYTHING LOOKS GOOD. IN THE CERVICAL SPINE THE TWO ANTERIOR CERVICAL PLATES ARE IN GOOD POSITION. THERE IS BONE GRAFT FORMING.¿ ON (B)(6) 2008 PATIENT PRESENTED FOR POST-OP FOLLOW UP. ¿X-RAYS SHOW THE ROD AND SCREW DEVICE IS IN GOOD POSITION. THERE IS BONE GRAFT FORMING IN THE POSTEROLATERAL GUTTERS.¿ ON (B)(6) 2008 PATIENT PRESENTED WITH SI JOINT DYSFUNCTION AND LOW BACK PAIN. PATIENT UNDERWENT BILATERAL SACROILIAC JOINT INJECTIONS. ON (B)(6) 2008 PATIENT PRESENTED WITH DDD AND DISCOGENIC PAIN AT L3-4. PATIENT UNDERWENT ALIF L3-4 USING A SYNTHES ANTERIOR PLATE, AN INTERFIX INTERBODY DEVICE, AND RHBMP-2/ACS. ON 1/26/2009 THE PATIENT PRESENTED WITH SI JOINT DYSFUNCTION AND LOW BACK PAIN. PATIENT UNDERWENT BILATERAL SACROILIAC JOINT INJECTIONS. ON 7/6/2009 THE PATIENT PRESENTED WITH S1 JOINT DYSFUNCTION AND LOW BACK PAIN. PATIENT UNDERWENT BILATERAL SACROILIAC JOINT INJECTIONS. ON (B)(6) 2009 THE PATIENT PRESENTED WITH DISCOGENIC PAIN L4-5 WITH FORAMINAL STENOSIS. THE PATIENT UNDERWENT TLIF AND FORAMINOTOMY L4-5 WITH IMPLANTATION OF A PEEK SPACER AND RHBMP-2/ACS. ON (B)(6) 2011 THE PATIENT PRESENTED WITH STENOSIS WITH INSTABILITY. THE PATIENT UNDERWENT POSTERIOR NONSEGMENTAL INSTRUMENTATION OF L1-2, POSTEROLATERAL FUSION L1-2, LAMINOTOMY AT L1 WITH FORAMINOTOMIES, REMOVAL OF PREVIOUS HARDWARE AT L2-3, AND EXPLORATION OF FUSION AT 2-3. ON (B)(6) 2011 PATIENT PRESENTED WITH LEFT S1 JOINT DYSFUNCTION AND LOW BACK PAIN. PATIENT UNDERWENT LEFT S1 JOINT INJECTION. ON (B)(6) 2011 THE PATIENT PRESENTED WITH NECK PAIN AND CERVICAL SPINE INSTABILITY. THE PATIENT UNDERWENT ACDF C7-T1 USING A PEEK SPACER AND ANTERIOR PLATING. ON (B)(6) 2011 PATIENT PRESENTED FOR FOLLOW UP FOR NECK SURGERY. X-RAYS INDICATED ¿THE ANTERIOR CERVICAL PLATE TO BE IN GOOD POSITION AT C3-4. YOU CAN ALSO SEE THE PLATE AT C6-C7. EVERYTHING IS WELL ALIGNED.¿ ON (B)(6) 2012 PATIENT PRESENTS FOR FOLLOW UP WITH COMPLAINTS OF NECK AND LOW BACK PAIN. X-RAYS INDICATED ¿ANTERIOR PLATE AND SCREWS ARE IN GOOD POSITION AT L4-L5. THE ROD AND SCREW DEVICE IS IN GOOD POSITION AT L1-L2. THERE APPEARS TO BE INCORPORATING BONE GRAFT. I CAN SEE THE ANTERIOR CERVICAL PLATES AT C3-C4 AND C7-T1. THE FUSION IS SOLID INTERCEDING THE TWO. ON (B)(6) 2012 PATIENT PRESENTED WITH SACROILIITIS WITH SI JOINT DYSFUNCTION. PATIENT UNDERWENT LEFT SI JOINT FUSION. ON (B)(6) 2012 PATIENT PRESENTED FOR POST-OP FOLLOW UP. ON (B)(6) 2012 PATIENT PRESENTED FOR FOLLOW UP. SHE IS NOT HAVING ANY RADICULAR COMPONENT TO HER PAIN. RANGE OF MOTION IS GOOD. THERE IS NO CLONUS. X-RAYS INDICATE BONE IMPLANTS IN GOOD POSITION. THERE APPEARS TO BE SOLID FUSION ALL THE WAY TO THE SACRUM. ON (B)(6) 2012 PATIENT PRESENTED FOR FOLLOW UP. X-RAYS INDICATED THAT ¿THE LOWER IMPLANT COULD BE IMPINGING ON THE NEURAL FORAMINA.¿ ON (B)(6) 2012 PATIENT PRESENTED FOR FOLLOWUP. CT INDICATED THAT THE IMPLANTS IN THE SI JOINT ARE WERE WELL AWAY FROM THE NERVE. ON (B)(6) 2012 PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2012 PATIENT PRESENTED FOR FOLLOW-UP AFTER LEFT S1 JOINT FUSION. PATIENT CONTINUES TO COMPLAIN OF PAIN, BUT STATES THAT SHE IS BETTER THAN PREOP. ON (B)(6) 2012 THE PATIENT PRESENTED WITH CONTINUED SYMPTOMS IN HER LEG AND NECK PAIN. X-RAYS INDICATED CERVICAL PLATES IN GOOD POSITION AT C3-4 AND C7-T1. LUMBAR FILMS SHOW THE S1 BONE IMPLANTS IN GOOD POSITION. ¿IT LOOKS LIKE THE LOWER IMPLANT MAY BE MIGRATED INTO THE NEURAL FORAMINA¿¿ ON (B)(6) 2013 THE PATIENT WAS DIAGNOSED WITH FORAMINAL STENOSIS L3-4, CERVICALGIA AND CERVICAL AND LUMBAR RADICULOPATHY.
(B)(6) 2007: INTRAOPERATIVE LATERAL LUMBAR SPINE: POSTERIOR FIXATION HAS BEEN PERFORMED. IT IS EXTREMELY DIFFICULT TO IDENTIFY THE LEVEL. L2 AND L3 WERE FAVORED. THE PATIENT WAS PRESENTED WITH PRE-OP DIAGNOSIS WAS LUMBAR STENOSIS L1-2 WITH INSTABILITY STATUS POST POSTERIOR FUSION. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR INSTRUMENTATION L1-2, POSTERIOR LATERAL FUSION L1-2, LUMBAR LAMINECTOMY L1-2, REMOVAL OF THE HARDWARE L2-3. 3-4, 4-5, REMOVAL OF BATTERY PACK. BONE MORPHOGENIC PROTEIN. POSTEROLATERAL FUSION 1-2 WITH DECOMPRESSION. THE HARDWARE WAS REMOVED AND DISTRACTION SHOWED NO MOTION AND IT WAS FELT THAT THE PATIENT HAD A SOLID FUSION. PEDICLES WERE SOUNDED BILATERALLY AT 1 AND 6.5 X 40 MM SCREWS WERE PUT IN PLACE. 40 X 7.5 MM SCREWS WERE PLACED IN L2. DECORTICATION OF THE LATERAL GUTTERS HAD BEEN PERFORMED, CULTURES HAD BEEN OBTAINED AND IRRIGATION WAS PERFORMED. THEN, BONE MORPHOGENIC PROTEIN WAS MIXED WITH HYDROXYAPATITE AND PLACED IN THE POSTERIOR LATERAL GUTTERS. USING THE KENISON LEKSELL, LAMINECTOMY WAS PERFORMED AT L1 WITH WIDE FORAMINOTOMIES. FOLLOWING THIS A PROBE COULD BE PASSED OUT THE NEURO-FORAMINA. IRRIGATION HAD BEEN PERFORMED, AND THEN TWO 5.5 RODS WECE CUT AND CONTOURED IN APPROPRIATE AMOUNT OF LORDOSIS, PUT INTO PLACE. TIGHTENED AND TORQUED TO THE APPROPRIATE FOOT POUNDS OF PRESSURE, AND A SINGLE HOLE 5 CROSS LENGTH WAS PUT INTO PLACE, TIGHTENED AND TORQUED TO THE APPROPRIATE FOOT POUNDS OF PRESSURE. THE BREAK-OFF SCREWS WERE BROKEN OFF. NO PATIENT COMPLICATION WAS NOTED. (B)(6) 2008: PATIENT VISITED THE OFFICE FOR FOLLOW UP OF SURGERY. X-RAYS: PLAIN X-RAY SHOWED THE ROD AND SCREW DEVICE WAS IN GOOD POSITION. BONE GRAFT IS INCORPORATING. IMPRESSION: LOW BACK PAIN. (B)(6) 2009: THE PATIENT HAD PRE AND POST OP OF SI JOINT DYSFUNCTION, LOW BACK PAIN. THE FOLLOWING PROCEDURE WAS PERFORMED: BILATERAL SACROILIAC JOINT INJECTIONS. NO COMPLICATIONS WAS REPORTED. (B)(6) 2008: PATIENT PRESENTED FOR THE FOLLOW-UP: SHE COMPLAINED OF PAIN IN THE LOWER BACK. SHE HAD THE SI JOINT INJECTIONS WHICH DID HELP HER ONLY TEMPORARILY. SHE GOT ABOUT 2 DAYS OF RELIEF. RANGE OF MOTION WAS LIMITED. BECAUSE OF HER CONTINUED PAIN WE ARE GOING TO GO AHEAD AND SET HER UP FOR A DISCOGRAM. IMPRESSION: OW BACK PAIN. (B)(6) 2008: PATIENT PRESENTED FOR DX LUMBOSACRAL SPINE AP/LAT: FINDINGS LUMBAR SPINE, AP AND LATERAL VIEWS SHOW LUMBAR FUSIONS WITH POSTERIOR DECOMPRESSIONS AT L4-S AND LS-S1. THERE ARE ALSO PEDICLE SCREWS AND FIXATION HARDWARE IN PLACE AT THE L2-3 LEVELS. NO SUBLUXATIONS WERE EVIDENT. IMPRESSION: EXTENSIVE LUMBAR FUSIONS. (B)(6) 2008 :PATIENT ADMITTED FOR LOW BACK PAIN, DEGENERATIVE DISC DISEASE, SPINAL STENOSIS (B)(6) 2008 : THE PATIENT PRESENTED FOR FOLLOW UP OF HER SURGERY. X-RAYS SHOW THE PLATE AND SCREWS IN GOOD POSITION. EVERYTHING IS WELL ALIGNED. THE CAGES ARE IN GOOD POSITION. IMPRESSION: LOW BACK PAIN (B)(6) 2008: PATIENT REPORTED LOW BACK PAIN. (B)(6) 2009: PATIENT PRESENTED FOR POSTOP FOLLOWUP. X-RAY SHOWED GOOD BONE GRAFT FORMING IN POSTEROLATERAL GUTTERS. (B)(6) 2009 : THE PATIENT PRESENTED WITH LEFT HIP AND LEFT LEG PAIN AND PAIN IN RIGHT THIGH. (B)(6) 2009: PATIENT PRESENTED FOR FOLLOW UP OF INJECTION. PATIENT REPORTED LITTLE PAIN AROUND SI JOINT ALSO THERE WAS PAIN AROUND LEFT CALF. (B)(6) 2009: PATIENT PRESENTED FOR POSTOP FOLLOWUP. X-RAY SHOWED INSTRUMENTATION IN GOOD POSITION AND FUSION APPEARS TO BE INCORPORATED. (B)(6) 2009: LOW BACK PAIN, DEGENERATIVE DISC DISEASE, SPINAL STENOSIS. (B)(6) 2009: PATIENT PRESENTED FOR POSTOP FOLLOW-UP. X-RAY SHOWED INSTRUMENTATION IN GOOD POSITION AND FUSION APPEARS TO BE INCORPORATED. (B)(6) 2009: PATIENT UNDERWENT MRI OF LUMBAR SPINE WITHOUT AND WITH CONTRAST DUE TO HISTORY OF PAIN, NUMBNESS AND WEAKNESS. IMPRESSION: EXTENSIVE DECOMPRESSIVE LAMINECTOMY CHANGE IN THE LUMBAR REGION AS DESCRIBED WITH INTERBODY FUSION CHANGES AL L3-L4. MILD DISC BULGES AT THE L3-L4 LEVEL. ENHANCING EPIDURAL SCAR TISSUE AT THE OPERATIVE SITE. (B)(6) 2009: THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: LUMBAR DEGENERATIVE DISC DISEASE. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: LUMBAR DISCOGRAPHY AT L2-3 AND L4-S UNDER FLUOROSCOPY WITH INJECTION OF CONTRAST. NO PATIENT COMPLICATIONS WERE REPORTED. IMPRESSION: POSITIVE PROVOCATIVE DISCOGRAPHY AT L4-5 WITH A NEGATIVE CONTROL DISC AT L2-3. THERE ARE MULTIPLE FLUOROSCOPIC IMAGES SHOWING CONTRAST INJECTED INTO THE DISCS AT L2-3 AND L4MS. RESULTS ARE AS FOLLOWS: AT L2-3, CONTRAST IS CENTRALLY CONTAINED 'WITHIN THE DISC. THERE IS NO EXTRAVASATION APPRECIATED. AT L4-5 CONTRAST IS EXTRAVASATED THROUGHOUT THE ANNULUS AND POSTERIORLY INTO THE EPIDURAL SPACE. IMPRESSION: ABNORMAL DISCOGRAPHY AT L4-5. (B)(6) 2009: PATIENT PRESENTED FOR FOLLOWUP OF DISCOGRAM, DISCOGRAM SHOWED REPRODUCTION OF PAIN AT L4-5. (B)(6) 2009: PATIENT UNDERWENT DX LUMBAR SPINE AP LATERAL: FINDINGS: FOUR INTRAOPERATIVE RADIOGRAPHS DEMONSTRATE A TRANSPEDICULAR FIXATION HARDWARE SPANNING THE L3-L4 LEVELS, AS WELL AS AN INTERBODY CAGE STRUT GRAFT AND ANTERIOR LUMBAR FUSION PLATE TRANSFIXING THE L4 AND L5 LEVELS. THE PATIENT HAD PRE AND POST OP DIAGNOSIS: DISCOGENIC PAIN, 4-5 WITH FORAMINAL STENOSIS. THE FOLLOWING PROCEDURES WERE PERFORMED: TRANSFORAMINAL LUMBAR INTERBODY FUSION, L4-5. FORAMIOTOMY, 4-5, WITH DISKECTOMY AT 4-5. IMPLANTATION OF PEEK SPACER. INTEROP AN X-RAY WAS OBTAINED TO VERIFY THE LEVEL. AFTER VERIFICATION OF THE LEVEL USING AN OSTEOTOME, RONGEUR AND KERRISONS, THE FUSION MASS WAS TAKEN DOWN AND THE NEURAL FORAMINA WAS OPENED. FACETECTOMY WAS DONE WITH COMPLETE OPENING OF THE FORAMINA. THE DISK SPACE WAS THEN LOCALIZED, AND AN ANNULOTOMY WAS PERFORMED, A DISCECTOMY WAS THEN PERFORMED. THEN, THE DISK SPACE WAS REAMED TO 9 MM, AND THE SPACER WAS INSERTED. UNDER FLUOROSCOPIC GUIDANCE, IT WAS POSITIONED IN THE PROPER POSITION. PRIOR TO THIS, BMP HAD BEEN PLACED ANTERIORLY. ONCE THE SPACER WAS IN, THE WAFER DEVICE WAS DISTRACTED TO 10 MM. THIS WAS CHECKED UNDER AP AND LATERAL FLUOROSCOPY, FELT TO BE IN GOOD POSITION. NO COMPLICATION WAS REPORTED. (B)(6) 2009: PATIENT PRESENTED FOR POSTOP FOLLOWUP, PATIENT REPORTED PAIN IN LEGS. (B)(6) 2010: PATIENT PRESENTED FOR POSTOP FOLLOW-UP, PATIENT REPORTED PAIN IN LOWER BACK RADIATING DOWN THE LEGS. (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW UP. X-RAY SHOWED SOLID CERVICAL FUSION. X-RAY OF HAND SHOWS DEGENERATIVE ARTHRITIC CHANGES. (B)(6) 2010: PATIENT REPORTED LEG PAIN. (B)(6) 2010: PATIENT UNDERWENT MRI SCAN OF THE LUMBAR SPINE: FINDINGS: SAGITTAL VIEWS REVEALED POSTOPERATIVE DECOMPRESSIVE LAMINECTOMY CHANGES AT L3-4, L4-5 AND L5-S1 WITH INTERBODY FUSION CHANGES AT THE L 3-4 LEVEL. POSTERIOR STABILIZING RODS AND ANCHORING PEDICLE SCREWS EXTEND FROM L2 TO L4. MINIMAL DISC BULGES WERE NOTED AT L3-4 AND L4-5. SAGITTAL T2 IMAGES REVEAL SIGNAL LOSS FROM THESE TWO DISCS CONSISTENT WITH DEGENERATION AND DESICCATION. THE CONUS MEDULLARIS APPEARED NORMAL. AXIAL VIEWS REVEAL THE DECOMPRESSIVE LAMINECTOMY CHANGES AT L3-4, L4-5 AND L5-S1. THERE ALSO APPEARED TO BE FUSION AT THE L4-5 LEVEL WITH DISC SPACER IN THE RIGHT SIDE OF THE DISC SPACE AT THIS LEVEL EXTENDING POSTERIOR TO ME POSTERIOR MARGIN OF THE DISC. THERE IS SCAR TISSUE TO THE RIGHT OF THE THECAL SAC AT THE L4-5 LEVEL AND SCAR TISSUE SEEN POSTERIOR TO THE THECAL SAC AT THE L5-S1 LEVEL. SCAR TISSUE ENHANCES ON POSTCONTRAST VIEWS WITH NO OTHER ENHANCING LESIONS. (B)(6) 2010: PATIENT UNDERWENT CT OF LUMBAR SPINE: HISTORY: BACK PAIN WITH LEFT LEG PAIN FOR TWO MONTHS. HISTORY OF FOUR BACK SURGERIES, SPINAL FUSION. SAGITTAL/ AXIAL, AND CORONAL IMAGES WERE PRODUCED. NO INTRAVENOUS OR INTRATHECAL CONTRAST WAS UTILIZED. COMPARISON IS MADE TO INTRAOPERATIVE VIEWS OF LUMBAR SPINE DATED (B)(6) 2009 AS WELL AS A CT SCAN OF THE LUMBAR SPINE PERFORMED ON (B)(6) 2008. FINDINGS: PEDICLE SCREW FIXATION HARDWARE IS IN PLACE AT THE LEVEL OF L2 AND L3 UNCHANGED SINCE PRIOR STUDY OF (B)(6) 2008. THERE IS A NEW ANTERIOR LUMBAR FUSION PLATE, ECCENTRIC TO THE LEFT, TRANSFIXING THE L3-4 LEVEL AS WELL AS AN INTERBODY CAGE STRUT GRAFT. ADDITIONALLY AN INTERBODY DEVICE IS SEEN AT THE LEVEL OF L4-S. THIS APPEARS ECCENTRICALLY LOCATED ON THE RIGHT EXTENDING INTO THE INFERIOR ASPECT OF THE RIGHT NEURAL FORAMEN. THERE IS DISC SPACE NARROWING AT LS-S1. HYPERTROPHIC CHANGES ARE NOTED IN THE POSTERIOR FACETS RELATED TO WIDE LAMINECTOMY AND POSTERIOR FUSION. IMPRESSION: POSTOPERATIVE CHANGES IN LUMBAR SPINE AS DETAILED ABOVE. THE INTERBODY DEVICE AT THE L4-S LEVEL APPEARS ECCENTRICALLY LOCATED AND EXTENDS INTO THE INFERIOR ASPECT OF RIGHT NEURAL FORAMEN. (B)(6) 2010: X-RAY SHOWED KICKED BACK CAGE AT L4-5. (B)(6) 2010: PATIENT REPORTED LEFT HIP PAIN. CAGE HAD SLIPPED BACK ON RIGHT AT L4-5. PATIENT ALSO HAD MORE SI JOINT PAIN ON LEFT SIDE. (B)(6) 2011: PATIENT UNDERWENT CERVICAL SPINE FINDINGS: TWO VIEW CERVICAL SPINE DEMONSTRATES ANTERIOR CERVICAL FUSION HARDWARE TRANS FIXING THE C3-C4 LEVEL AS WELL AS THE C6-C7 LEVEL. BONY ANKYLOSIS OF C5 AND C6 WAS NOTED. PREVERTEBRAL SOFT TISSUES WERE NOT WELL CHARACTERIZED. THERE WAS NO HARDWARE LOOSENING OR FAILURE. (B)(6) 2011: PATIENT UNDERWENT MRI OF THE LUMBAR SPINE: SPINE ECHO IMAGING WAS OBTAINED IN SAGITTAL AND AXIAL PLANES USING T1 AND T2 WEIGHTING. PATIENT HAD MULTILEVEL LUMBAR FUSIONS. PEDICLE SCREW ARTIFACTS IN PLACE AT L2 AND L3. ANTERIOR PLATE AND SCREW FIXATION WAS SEEN ACROSS L3 AND L4. PEDICLE SCREW TRACTS WERE SEEN AT L4, LS, AND S1. EXTENSIVE POSTERIOR DECOMPRESSIONS FROM L2 TO 51 ARE PRESENT. JUST SLIGHT BULGING DISC ANNULUS WAS SEEN AT L3-4. THERE IS NEURAL FORAMEN NARROWING BILATERALLY AT L3-4 AND L4-5 CAUSED BY FACET HYPERTROPHY. THERE WAS NO MASS IN THE SPINAL CANAL. NO SPINAL STENOSIS WAS EVIDENT. THERE WAS A SLIGHT BULGING DISC ANNULUS AT T11-T12. IMPRESSION: EXTENSIVE LUMBAR FUSIONS FROM L2 DOWN TO S1. NEURAL FORAMEN NARROWING DUE TO FACET HYPERTROPHY AT L3-4 AND L4-5. SLIGHT BULGING DISC AT T11-T12. PATIENT ALSO UNDERWENT MRI OF CERVICAL SPINE: PATIENT HAD EXTENSIVE C-SPINE SURGERY TO INCLUDE ACF PLATE WITH ANCHORS AT C3 AND 4, BONY FUSION BETWEEN C5- AND C6 AND AN ACF PLATE ANCHORED AT C6 AND C7. THE CANAL, LATERAL RECESSES, AND NEURAL FORAMEN ARE WIDELY PATENT WITHOUT NARROWING BY DISC OR BONE. NO SYMPTOMS OF DISC HERNIATIONS, BONE SPURS, OR SIGNIFICANT COMPRESSION OF THE CORD AT ANY LEVEL. THE CORD HAS NORMAL SIZE AND SIGNAL INTENSITY FROM THE CERVICOMEDULLARY JUNCTION DOWN THROUGH THE T4 LEVEL OF THORACIC SPINE. THE C2-3 DISC WAS STILL WELL PRESERVED. THE C6-7 DISC SPACE WAS NARROWED AND THERE WAS A LITTLE BULGE OF THE DISC AT C7-T1 WITHOUT CORD COMPRESSION. NO EVIDENCE OF INFECTION SEEN ABOUT THE NEITHER CERVICAL SPINE NOR EDEMATOUS BONE OR PARASPINAL SOFT TISSUES. BONE MARROW INTENSITY LOOKED NORMAL. POSTERIOR ELEMENTS WERE INTACT. THE 4TH VENTRICLE AND CERVICOMEDULLARY JUNCTION ARE ALSO NORMAL. IMPRESSION: EXTENSIVE SURGICAL FINDINGS WITH BOTH BONY FUSION AND ACF PLATES NOTED. THE CORD LOOKS NORMAL AT ALL LEVELS WITHOUT ANY COMPRESSION OF THE CANAL, LATERAL RECESSES, OR NEURAL FORAMEN AT ANY LEVEL OF THE CERVICAL SPINE. MILD BULGING OF DISC WITHOUT CORD COMPRESSION OR STENOSIS AT C7-TL. NO TUMOR, INFECTION, OR FRACTURE. (B)(6) 2011: PATIENT CAME IN FOR A WOUND CHECK. (B)(6) 2011: PATIENT REPORTED LOW BACK PAIN, X-RAY SHOWED PIECE OF BONE THAT WAS PLACED ANTERIORLY HAD RETROPULSED BACK INTO CANAL. (B)(6) 2011: XRAY SHOWED DEGENERATIVE CHANGES AT LEVEL ABOVE FUSION OF C7-T1. (B)(6) 2011: PATIENT PRESENTED FOR POST OP FOLLOWUP AND REPORTED BACK PAIN. XRAY SHOWED THAT FUSION WAS INCORPORATING. (B)(6) 2011, PATIENT REPORTED SHE HAD LEG PAIN AND BACK PAIN WAS RESOLVED AFTER LUMBAR SURGERY. (B)(6) 2011, PATIENT REPORTED NECK PAIN DOCTOR PRESCRIBED ACDF C7- T1. (B)(6) 2011: THE PATIENT HAD FOLLOWING DIAGNOSIS. LEFT SI JOINT DYSFUNCTION. LOW BACK PAIN. THE FOLLOWING PROCEDURE WAS PERFORMED LEFT SI JOINT INJECTION. NO COMPLICATIONS WAS REPORTED. (B)(6) 2011: PATIENT PRESENTED FOR POSTOP FOLLOWUP OF ANTERIOR CERVICAL FUSION. (B)(6) 2011: PATIENT UNDERWENT MR ARTHROGRAM LEFT SHOULDER. MULTIPLANAR MULTI ECHO IMAGES WERE OBTAINED INCLUDING MULTIPLANAR 'I1I IMAGES WITH FAT SUPPRESSION. FINDINGS: ON THE FAT SUPPRESSED T1 IMAGES WAS NOTED CONTRAST MATERIAL CONTAINED WITHIN THE JOINT SPACE WITH NO EXTRAVASATION INTO THE SURROUNDING BURSA. SUPRASPINATUS. INFRASPINATUS AND SUBSCAPULARIS TENDONS APPEAR INTACT WITH NO ABNORMAL SIGNAL FOCUS. BICEPS TENDON WAS SEEN IN THE BICIPITAL GROOVE. (B)(6) 2011: PATIENT REPORTED LEFT SHOULDER AND BACK PAIN. MRI SHOWED PREVIOUS DISTAL CLAVICLE RESECTION. (B)(6) 2012: PATIENT CAME FOR PREOP EVALUATION AND REPORTED LOW BACK PAIN. (B)(6) 2012: CT OF THE LUMBAR SPINE: HISTORY: LOW BACK PAIN, LEFT SI JOINT PAIN. FINDINGS: COMPARISON WAS MADE WITH (B)(6) 2010. AGAIN SEEN WAS POST-SURGICAL ANTERIOR FUSION OF L3-L4, SIMILAR WHEN COMPARED WITH THE PRIOR STUDY. L2-L3 POSTERIOR SPINAL FIXATION HARDWARE HAD BEEN REMOVED AND THERE HAS BEEN PLACEMENT OF L 1-L2 POSTERIOR SPINAL FIXATION HARDWARE. POSTERIOR DECOMPRESSION OF L4 AND L5 WAS SIMILAR WHEN COMPARED WITH THE PRIOR STUDY. VERTEBRAL BODY HEIGHTS WERE PRESERVED. ALIGNMENT WAS UNCHANGED. THERE WAS MULTILEVEL DEGENERATIVE FACET ARTHROPATHY, LIKELY WITH BILATERAL POSTEROLATERAL BONE GRAFTING AT THE L4-L5 AND LS-S1 LEVELS. THERE WAS NO EVIDENCE OF HARDWARE FAILURE; THERE WAS PERSISTENT OSSEOUS OVERGROWTH AT L4-L5 ON THE RIGHT RESULTING IN RIGHT L4-L5 NEURAL FORAMINAL STENOSIS. THERE HAD BEEN NO SIGNIFICANT INTERVAL CHANGE IN POSITION OF THE ECCENTRICALLY LOCATED INTERBODY SPACER AT L4-L5 ON THE RIGHT. IMPRESSION: INTERVAL REMOVAL OF L3-L4 POSTERIOR SPINAL FIXATION HARDWARE AND PLACEMENT OF L1-L2 POSTERIOR SPINAL FIXATION HARDWARE. NO OTHER SIGNIFICANT INTERVAL CHANGE. (B)(6) 2012: DX CHEST 2 VIEW: PA AND LATERAL CHEST: INDICATION: PREOPERATIVE EVALUATION. FINDINGS/IMPRESSION: POSTOPERATIVE CHANGES ARE SEEN NEAR THE CERVICOTHORACLC JUNCTION AND ALSO NEAR THE THORACOLUMBAR JUNCTION WITH NO GROSS HARDWARE COMPLICATION IDENTIFIED. THERE WAS RESORPTION OF THE DISTAL CLAVICLES BILATERALLY WHICH COULD BE SEEN WITH SUCH ENTITIES AS HYPERPARATHYROIDISM AND HYPERTHYROIDISM-PLEASE CORRELATE. THE LUNGS WERE CLEAR AND THE HEART SIZE WAS NORMAL. DX LUMBAR SPINE AP AND LAT: FINDINGS: FIXED GRADE I ANTEROLISTHESIS OF L3 ON L4. POSTERIOR INTERPEDICULAR SCREW/CABLE CONSTRUCT IS SEEN SPANNING L112WITH NO HARDWARE COMPLICATION IDENTIFIED. THERE WAS ANTERIOR DISKECTOMY AND FUSION AT L3/4 WITH NO HARDWARE COMPLICATION. EXTENSIVE LAMINECTOMY CHANGES WERE SEEN THROUGHOUT THE LUMBAR SPINE WITH MATURE-APPEARING ANKYLOSIS INVOLVING THE POSTERIOR ELEMENTS ESSENTIALLY FROM L2-3 THROUGH THE SACRUM. MILDLY ADVANCED DISCOGENIC DEGENERATIVE DISEASE AT THE THORACOLUMBAR JUNCTION AND ALSO NEAR THE LUMBOSACRAL JUNCTION. NO INCIDENTAL FINDINGS. IMPRESSION: POSTOPERATIVE AND DEGENERATIVE CHANGES AS ABOVE. NO ACUTE ABNORMALITY. (B)(6) 2012: PATIENT CAME FOR PREOP EVALUATION AND REPORTED LOW BACK PAIN. (B)(6) 2012: THE ANTERIOR DEVICE AT L3-4 POSITION ROLLED FUSION WAS SOLID ALL THE WAY FROM ONE DOWN TO THE SACRUM WE DO SEE THE SMO IMPLANTS THEY LOOKED GOOD THERE WAS NO LUCENCY AROUND THE PATIENT WAS QUITE SOME TIME SHE STATES SHE WAS BETTER THAN SHE WAS PREOPERATIVELY. FOLLOWED ALONG OSCAR BACK IN THE OFFICE AGAIN HER X-RAYS LOOKED GOOD SHOW SOLID FUSION FROM L1 TO THE SACRUM. (B)(6) 2012: PATIENT REPORTED LOW BACK PAIN. X-RAY SHOWED ANTERIOR DEVICE TO BE IN GOOD POSITION AT L3-4, OLD FUSION IS SOLID FROM L1 TILL SACRUM. THERE IS NO LUCENCY AROUND THEM. (B)(6) 2013: THE PATIENT UNDERWENT MR- LUMBAR SPINE DUE TO LOWER EXTREMITY PAIN: FINDINGS: SAGITTAL VIEWS REVEAL MILD SCOLIOSIS IN THE LUMBAR SPINE WITH CONVEXITY TO THE LEFT. POSTOPERATIVE ANTERIOR INTERBODY FUSION CHANGES WERE NOTED AT L3-4 WITH DISC SPACER IN PLACE WITH COMPRESSION PLATE ANCHORS AND ANTERIOR ASPECT OF THESE VERTEBRAL BODIES WITH METAL SCREWS. THERE WAS ALSO NOTED DECOMPRESSIVE LAMINECTOMY CHANGES AT L3-4, L4-S, AND L5-S1. DECOMPRESSIVE LAMINECTOMY CHANGES ARE ALSO NOTED AT L1-2 WITH POSTERIOR STABILIZING RODS WITH ANCHOR AND PEDICLE SCREWS. THERE WAS RESIDUAL SPONDYLOSIS AT L3-4 AND L4-5. MILD DISC BULGE IS NOTED IN THE LOWERS THORACIC SPINE. NEURAL FORAMINAL STENOSIS IS SEEN. THE CONUS MEDULLARIS APPEARS NORMAL. AXIAL VIEWS AGAIN REVEAL THE POSTOPERATIVE DECOMPRESSIVE LAMINECTOMY CHANGES AT L3-4, L4-5, AND L5-S1 WITH INTERBODY FUSION CHANGES AT L3-4. THERE WAS ALSO NOTED INTERBODY FUSION CHANGES AT THE L4-S LEVEL WITH DISC SPACER ON THE RIGHT SIDE OF THIS DISC SPACE. THE DECOMPRESSIVE LAMINECTOMY CHANGES. L1-2 WERE NOTED WITH FLUID COLLECTION POSTERIORLY. SCAR TISSUE WAS NOTED IN THE CANAL AT THE L3-4 LEVEL SURROUNDING THE THECAL WITH ENHANCEMENT ON POST CONTRAST VIEWS. THERE WAS ALSO NOTED SOME ENHANCEMENT POSTERIOR TO THE THECAL SAC AT L4-5 AND L5-S1. IMPRESSION: MILD SCOLIOSIS LUMBAR SPINE. POSTOPERATIVE DECOMPRESSIVE LAMINECTOMY CHANGES AT L3-4, L4-5, AND L5-S1 WITH FUSION CHANGES AT L3-4 AND L4-S. ENHANCING EPIDURAL SCAR TISSUE AT THESE LEVELS, AS DESCRIBED. POSTOPERATIVE DECOMPRESSIVE LAMINECTOMY CHANGES AT LL-2 WITH POSTERIOR FUSION. FLUID COLLECTION POSTERIOR TO THE THECAL SAC POSSIBLY REPRESENTING, PSEUDOMENINGOCELE. RESIDUAL SPONDYLOSIS AT L3-4 AND L4-5. MILD DISC BULGE IN THE LOWER THORACIC SPINE AS DESCRIBED. (B)(6) 2013: HISTORY: NECK PAIN RADIATING INTO THE LEFT SHOULDER WITH NUMBNESS AND TINGLING IN THE LEFT ARM FOR FOUR MONTHS. CERVICAL FUSION ONE YEAR AGO. MULTIPLE OTHER NECK SURGERIES OVER THE PAST FIVE YEARS. SAGITTAL T1 T2 STIR AXIAL T2, 3D AND AXIAL GRADIENT ECHO IMAGES WERE OBTAINED. FINDINGS: COMPARISON IS MADE WITH THE EXAM DATED (B)(6) 2011. PATIENT HAS HAD MULTIPLE ANTERIOR FUSIONS WITH ANTERIORMETAL ARTIFACT AT C3-4, ANTERIOR FUSION WITHOUT A METAL PLATE AT C5-6 THERE ALSO APPEARS TO BE AN ANTERIOR PLATE AT C7-T1. THERE IS NARROWING OF THE AP DIAMETER OF THE THECAL SAC THROUGHOUT THE CERVICAL SPINE BUT I DO NOT SEE ANY DEFINITE CORD IMPINGEMENT BY DSC MATERIAL. THERE DOES APPEAR TO BE SOME POSTERIOR OSTEOPHYTE AT C4 WHICH IS UNCHANGED FROM THE PREVIOUS EXAM. NO OTHER SIGNIFICANT FINDINGS. NO DEFINITE INTERVAL CHANGE. IMPRESSION: EXTENSIVE POST-OPERATIVE CHANGES THROUGHOUT THE CERVICAL SPINE WITH SMALL CENTRAL OSTEOPHYTE AT THE LEVEL OF C4 WHICH CAUSES MILD IMPINGEMENT OF THE CORD. NO OTHER ACUTE RADIOGRAPHIC ABNORMALITIES OR INTERVAL CHANGES IDENTIFIED. (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW-UP, DOCTOR ADVISED SELECTIVE NERVE ROOT BLOCK AT L3-4, FACET BLOCKS AT C3-4, 4-5, AND 5-6.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 394800 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110608AAI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |