INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-03021
- Event Type
- Injury
- Date Received
- July 7, 2014
- Report Date
- September 28, 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). 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.
(B)(4).
ON (B)(6) 2009 PREOP DIAGNOSIS: DELAYED UNION; POSSIBLE PSEUDOARTHROSIS L5-S1; POSSIBLY PAINFUL HARDWARE. PATIENT UNDERWENT THE FOLLOWING PROCEDURE: EXPLORATION OF PREVIOUS FUSION, LUMBAR FUSION L5-S1; REMOVAL OF INTERNAL FIXATION L5-S1; REPAIR OF DELAYED UNION USING BMP AND MASTERGRAFT; CONTINUOUS NEUROELECTROPHYSIOLOGICAL MONITORING THE ENTIRE CASE. END CAPS WERE REMOVED. RODS WERE REMOVED AND THERE APPEARED TO BE SOME LOOSENING OF THE SCREWS AT THE UPPER LEVEL. THESE WERE THEN REMOVED. THEY WERE PROBED AND APPEARED TO BE IN NO VIOLATION OF THE PEDICLES. BECAUSE OF THIS, AND THE PATIENT HAD JUST PREVIOUSLY HAD AN A-LIFT WITH A BUTTRESS PLATE THREE DAYS AGO, IT WAS FELT THAT RE-ENFORCEMENT SHOULD BE DONE POSTERIORLY AND THE TISSUE WAS REMOVED LATERALLY BETWEEN THE TRANSVERSE PROCESSES OF L5 AND THE SACRAL ALA AND THE LATERAL GUTTERS USED WERE THEN CURETTED AND CLEANED AND SCRAPED AWAY. DECORTICATION WAS DONE. BMP WITH MASTERGRAFT WERE TAKEN AND PLACED OUT LATERALLY IN THE GUTTERS BETWEEN L5 AND S 1. PRIOR TO DOING THIS COPIOUS IRRIGATION WAS DONE. ONCE THIS WAS DONE, DRAIN WAS LEFT DEEP BELOW THE FASCIA. THE FASCIAL WAS CLOSED USING 1-0 VICRYL, SUBCUTANEOUS TISSUE WAS CLOSED USING 1-0, 2-0 COATED VICRYL AND THE SKIN WAS CLOSED WITH SURGICAL STAPLES. THE PATIENT TOLERATED THE PROCEDURE WELL AND WENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. ON (B)(6) 2009 PATIENT WAS DISCHARGED. ON (B)(6) 2009 PATIENT PRESENTED FOR CT LUM SPINE W/O CONTR DUE TO BACK PAIN, HELICAL SCANNING T12-S2. IMPRESSION: FUSION AND INSTRUMENTATION AT L5-S1. THERE WAS A SLIVER OF BONE IN THE LEFT ANTERIOR CANAL JUST POSTERIOR TO THE UPPER MARGIN OF S1. THERE WAS ALSO MINIMAL PROTUSION OF THE LEFT SCREW INTO THE CANAL. ON (B)(6) 2010 PATIENT PRESENTED TO OFFICE FOR FOLLOW-UP DUE TO PAIN IN HER BACK, INTO THE RIGHT HIP, AND THIGH, AS WELL AS SOME IN THE NECK AND SHOULDERS. THE MRI OF THE LOWER BACK HAS A LOT OF ARTIFACT AND MAY BE A DEGENERATED DISC ABOVE HER PREVIOUSLY FUSED LEVELS. AS FAR AS THE NECK IS CONCERNED, SHE DOES HAVE A DEGENERATED DISC AT 5-6 AND 6-7 WITH A POSSIBLE DISC OSTEOPHYTE COMPLEXES AND SUBL IGAMENTOUS PROTRUSION. SHE SAYS PRIOR TO THE ACCIDENT, SHE HAS NEVER HAD PROBLEMS WITH HER NECK OR HER SHOULDERS. ON (B)(6) 2010 PATIENT PRESENTED TO OFFICE FOR FOLLOW-UP DUE TO PAIN HAS GOTTEN A LITTLE WORSE. SHE HAD CONTINUED TO HAVE DISCOMFORT IN HER NECK, RIGHT SHOULDER, RIGHT ARM AS WELL AS HER BACK, RIGHT HIP, AND RIGHT LEG. ON (B)(6) 2010 PATIENT VISITED HOSPITAL POST LUMBAR DISC SURGERY. IMPRESSION: RIGHT HERNIATED DISC, DEGENERATIVE. PATIENT HAD A MYELOGRAM. AFTER REVIEWING THE X-RAYS, SHE DOES HAVE DEGENERATIVE DISC PROBLEMS AT C5-6, C6-7, WHICH APPEARS TO BE CAUSING SOME EARLY ENCROACHMENT ON THE CANAL. SHE WAS HAVING SOME PAIN IN HER NECK, SHOULDER, OFF TO THE RIGHT SIDE. HER BIGGEST PROBLEM THOUGH APPEARS TO BE SEVERE PAIN IN HER BACK, RIGHT HIP, AND RIGHT LEG. SHE SAYS THAT SHE WAS DOING VERY WELL UNTIL A MOTOR VEHICLE ACCIDENT ON (B)(6) 2009. CT LUM SPINE POST MYELO: THE POST MYELOGRAPHY SCAN AND REVEALS A FRAGMENTED INTERBODY FUSION BONE GRAFT AT L5-S1. A DEFINITE DETERMINATION OF SOLIDARITY AT THE FUSION SITE CANNOT BE MADE. INCIDENTAL NOTE IS MADE OF THE REMOTE SCREW HOLES IN THE L5 AND S1 PEDICLES. ON (B)(6) 2010 PATIENT PRESENTED TO OFFICE FOR FOLLOW-UP DUE TO PAIN IN HER BACK, RIGHT BUTTOCK, AND DOWN THE BACK HIP FRONT OF THE LEG, AS WELL AS A RIGHT GROIN. PHYSICAL EXAMINATION: THE BACK BRACE WAS REMOVED. THERE IS MARKED MIDLINE TENDERNESS AND BILATERAL PARAVERTEBRAL SPASM WITH TENDERNESS. THERE WAS PAIN ON PALPATION OF BOTH BUTTOCKS CHEEKS. SCIATIC NOTCH DISCOMFORT WAS PRESENT ON THE RIGHT. SHE HAS A FOOT DROP ON THE RIGHT. STRAIGHT LEG RAISING WAS NOT TESTED BECAUSE THE PATIENT WAS IN A LOT OF PAIN. ON (B)(6) 2010 PATIENT EXPERIENCED SEVERE LOW BACK AND BILATERAL LEG PAIN AFTER AN AUTOMOBILE ACCIDENT 6 MONTHS AGO. THERE IS NO HISTORY OF DIABETES. DEEP TENDON REFLEXES ARE 2+ AND EQUAL. HER TOES ARE DOWNGOING. EMG SUMMARY: SUMMARY OF NCS THE LOWER EXTREMITY NERVE CONDUCTION VELOCITIES AN: WITHIN NORMAL LIMITS WITH ADEQUATE AMPLITUDES. THE AURAL RESPONSES AND H. REFLEXES WERE ALSO NORMAL. SUMMARY OF EMG: THE NEEDLE STUDY WAS COMPROMISED BY SIGNIFICANT PAIN ON TESTING MANEUVER. NO EVIDENCE OF DENERVATION WAS SEEN. THE MOTOR UNIT POTENTIAL OBSERVED APPEARED NORMAL. ASSESSMENTS: . RADICULOPATHY LUMBSACRAL NEC. THIS WAS NORMAL EMG OF BOTH LEGS THOUGH S FULL INTERFERENCE PATTERN WAS NOT SEEN ON NEEDLE STUDY SECONDARY TO PAIN. ON (B)(6) 2010 PATIENT PRESENTED TO OFFICE FOR FOLLOW-UP DUE TO WORSENING AXIAL BACK PAIN AS WELL AS RIGHT GREATER THAN LEFT HIP PAIN. THIS IS GETTING WORSE. SHE ALSO HAS HER BASELINE NECK PAIN, WHICH WAS ALSO NOT IMPROVING. ON (B)(6) 2010 PATIENT HAD THE FOLLOWING IMPRESSION: STATUS POST BACK PROCEDURES. FRACTURE OF THE FEMORAL RING ALLOGRAFT THAT WAS PLACED IN THE INTERSPACE FROM AN ANTERIOR APPROACH WITH OSTEOPHYTIC SPURRING.
IT WAS REPORTED THAT ON (B)(6) 2008, REPORTEDLY, A MRI WAS REVIEWED WHICH DEMONSTRATED SOME DEGENERATIVE CHANGES WITH THE CENTRAL PROTRUSION AT L4-5 AND L5-S1. ON (B)(6) 2008, REPORTEDLY, A LUMBAR MYELOGRAM REVEALED DEGENERATIVE DISC DISEASE L1-2, L2-3, L4-5, AND L5-S1. THERE WAS MODERATE NARROWING OF THE TWO LOWER INTERSPACES. A MYELOGRAM CT REVEALED DEGENERATIVE DISC DISEASE T12-L1, L1-2, L2-3, L4-5, AND L5-S1 WITHOUT EVIDENCE OF DOMINATE HERNIATION OR CANAL STENOSIS. ON (B)(6) 2008 THE PATIENT PRESENTED WITH LUMBAR DEGENERATED COLLAPSE, L5-S1. ON (B)(6) 2008 THE PATIENT PRESENTED WITH A 15 YR HISTORY OF LOWER BACK PAIN, HIP PAIN, AND LEG PAIN WITH OCCASIONAL NUMBNESS. SYMPTOMS HAD WORSENED SINCE APRIL. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF A POSTER-LATERAL FUSION L5-S1 BILATERALLY, DECOMPRESSION FORAMINOTOMIES L5-S1 BILATERALLY; INTERNAL FIXATION L5- SACRUM; AUTOGRAPH FROM LAMINAR DECOMPRESSION FOR USE IN LATERAL FUSION FOR DEGENERATIVE DISC DISEASE WITH DISC PROTRUSION; AND FORAMINAL ENCROACHMENT L5-S1 WITH LOW TAKEOFF OF S1 NERVE ROOT. PER THE OPERATIVE REPORT ¿¿ LOCAL BONE THAT HAD BEEN TAKEN WAS PLACED LATERALLY IN THE GUTTERS AS WELL AS BMP AND MASTERGRAFT¿¿ NEURO-ELECTROSURGICAL MONITORING WAS UNREMARKABLE. IT WAS NOTED THAT BECAUSE OF THE SIZE OF THE PATIENT ¿IT ADDED SIGNIFICANT DIFFICULTY AND TIME TO THE OPERATIVE PROCEDURE¿. IT WAS ALSO NOTED THAT THE PATIENT THAT THE PATIENT¿¿LOST 400 CC OF BLOOD AND WAS GIVEN 200CC BACK. ¿ ON (B)(6) 2008 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2009 THE PATIENT PRESENTED WITH BACK PAIN AND UNDERWENT A LUMBAR SPINE CT WHICH DEMONSTRATED POSTERIOR SPINAL FIXATION RODS AND INTER-PEDICULAR SCREWS AT L5-S1 THAT WERE NEW FROM THE COMPARISON T MYELOGRAM STUDY. THERE WAS PERSISTENT NARROWING OF THE INTERVERTEBRAL DISC HEIGHT AT L5-S1. THERE WAS MILD NARROWING OF THE INTERVERTEBRAL DISC HEIGHT AT L4-5. THERE WERE MILD ENDPLATE DEGENERATIVE SPURS OFF THE VERTEBRAL BODIES THROUGHOUT THE LUMBAR SPINE. THESE WERE PREDOMINATELY ANTERIOR. HOWEVER, POSTERIOR SPURRING OF THE INFERIOR ENDPLATE OF L1 WAS IDENTIFIED IN CONJUNCTION WITH A MODERATE DISC BULGE OR PROTRUSION. THERE ARE ALSO FOCI OF EFFACEMENT OF THE VENTRAL ASPECT OF THE THECAL CONTRAST COLUMN SUGGESTING DISC BULGES OR PROTRUSIONS AT T12-L1, L2-3 AND L4-5. THEY COULD NOT EXCLUDE A SUBTLE DISC BULGE OR PROTRUSION AT L3-4. THE CHANGES WERE RELATIVELY STABLE IN RETROSPECT BACK TO A PRIOR CT MYELOGRAM STUDY. THE LUMBAR VERTEBRAE AND INTERVERTEBRAL DISCS WERE OTHERWISE NORMAL IN HEIGHT AND ALIGNMENT. THERE WAS NO EVIDENCE OF FRACTURE OR SUBLUXATION. THE CONUS MEDULLARIS TERMINATED AT THE L1 LEVEL AND WAS OF NORMAL CONTOUR AND APPEARANCE. THERE WAS SOME REDUNDANCY OF THE INTRA-THECAL NERVE ROOTS WITH CURVILINEAR COURSE. THE REMAINDER OF THE INTRA-THECAL NERVE ROOTS WERE UNREMARKABLE. THERE ARE NO SIGNIFICANT PARAVERTEBRAL SOFT TISSUE ABNORMALITIES. THE PATIENT ALSO UNDERWENT A LUMBAR SPINE MYELOGRAM WHICH SHOWED FINDINGS SUGGESTIVE OF FAIRLY PROMINENT DISC BULGES OR PROTRUSIONS AT L1-2, L2-3, AND L4-5 AND POSSIBLY L3-4. THERE WAS NARROWING OF THE INTERVERTEBRAL DIS HEIGHT AT L4-5 AND L5-S1. THERE WAS NO SIGNIFICANT MYELOGRAPHIC BLOCK AND NERVE ROOTS SLEEVES APPEARED RELATIVELY WELL OPACIFIED. ON (B)(6) 2009 THE PATIENT PRESENTED WITH BACK, BUTTOCKS, AND THIGH PAIN. THE PATIENT EXPRESSED CONCERN THAT THE S1 PEDICLE SCREW WAS SHIFTING. ASSESSMENT: POSSIBLE PSEUDOARTHROSIS. ON (B)(6) 2009 THE PATIENT PRESENTED WITH PAIN AND THE PREOPERATIVE DIAGNOSIS OF A POSSIBLE PEDICLE SCREW SHIFTING AND PSEUDOARTHROSIS. THE PATIENT UNDERWENT ANTERIOR SPINAL FUSION L5-S1, ANTERIOR LUMBAR DISKECTOMY L5-S1, AND ANTERIOR SPINAL INSTRUMENTATION L5-S 1, WITH CONTINUOUS NEUROPHYSIOLOGICAL MONITORING THROUGHOUT THE ENTIRE CASE BY ACCESS SURGERY AN ANTERIOR LUMBAR INTERBODY FUSION AND HARDWARE REMOVAL WITH EXPLORATION OF FUSION AND WITH INSTRUMENTATION AND BONE MORPHOGENIC PROTEIN. IT SHOULD BE NOTED THAT A MIDLINE APPROACH WAS UNDERTAKEN TRANSABDOMINAL BECAUSE OF RETROPERITONEAL SCARRING. PER THE OPERATIVE REPORT: ¿A PIECE OF MACHINED ALLOGRAFT FEMORAL RING WAS OPENED AT THE BACK TABLE AND THEN FILLED WITH PROGENIES PLUS. AT THIS POINT END PLATES WERE SCRAPED ONE LAST TIME. ONCE THERE WAS BLEEDING BONE FROM BOTH END PLATED THE FEMORAL RING STRUT WAS INSERTED INTO THE DISC SPACE. ONCE AT THE APPROPRIATE DEPTH INSERTER WAS REMOVED AND THEN ATTENTION PAID TO INSTRUMENTATION. PYRAMID PLATE WAS USED INITIALLY; HOWEVER, GIVEN THE PA TIENT'S BONE QUALITY ONE SCREW WAS NOT ADEQUATE FOR THE SUPERIOR LEVEL. THEREFORE A FOUR-HOLE PLATE WAS USED. THIS WAS PLACED OVER THE ALLOGRAFT AND NEXT STERNAL WIRE WAS USED TO GAIN ENTRY TO THE VERTEBRAL BODY. 3.5 X 65 SCREWS WERE PLACED IN L5 AS WELL AS S1. AT THIS POINT INSTRUMENTATION WAS COMPLETE. PER THE OPERATIVE REPORTS IT SHOULD BE NOTED THAT ¿¿THERE WAS BONE POSTEROLATERALLY IN THE GUTTERS; HOWEVER, IT MAY HAVE BEEN A FLOATING BONE NOT HAVING A SOLID UNION FROM WHAT COULD BE APPRECIATED. AT THIS POINT APPROPRIATE DRIVERS WERE USED IN ORDER TO REMOVE THE LOCKING NUT. FOLLOWING THIS, THE RODS WERE REMOVED. NEXT THE ENDCAPS WERE SPUN AND THEN EACH OF THE FOUR SCREWS WAS REMOVED. AT THIS POINT EXPLORATION OF FUSION COMMENCED. SCRAPING OF LATERAL GUTTERS DEMONSTRATED THE FUSION MASS CAME UP TO, HOWEVER, NOT INCLUDING THE SUPERIOR PEDICLE. GIVEN THIS, LOCAL AUTOGRAFT WAS TAKEN FROM THE FUSION MASS ALONG WITH THE USE OF OSTEOTOME IN ORDER TO DECORTICATE THE LATERAL GUTTERS AND THEN A COMBINATION OF THIS MATERIAL ALONG WITH BONE MORPHOGENIC PROTEIN AND MASTERGRAFT WAS PLACED OUT LATERALLY IN THE GUTTERS.¿ NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2009 THE PATIENT UNDERWENT EXPLORATION OF PREVIOUS FUSION OF LUMBAR FUSION L5-S1 WITH REMOVAL OF INTERNAL FIXATION L5-S1, AND REPAIR OF DELAYED UNION USING BMP AND MASTERGRAFT, CONTINUOUS NEUROELECTROPHYSIOLOGICAL MONITORING DURING THE ENTIRE CASE FOR DELAYED UNION AND POSSIBLE PSEUDOARTHROSIS L5-S1, POSSIBLE PAINFUL HARDWARE, PER THE OPERATIVE REPORT ¿...SCAR TISSUE WAS REMOVED OFF THE LAMINA AND THE FACETS. ONCE THIS WAS DONE, SCAR TISSUE WAS REMOVED. END CAPS WERE REMOVED. RODS WERE REMOVED AND THERE APPEARED TO BE SOME LOOSENING OF THE SCREWS AT THE UPPER LEVEL. THESE WERE THEN REMOVED. THEY WERE PROBED AND APPEARED TO BE IN NO VIOLATION OF THE PEDICLES. BECAUSE OF THIS, AND THE PATIENT HAD JUST PREVIOUSLY HAD AN A-LIFT WITH A BUTTRESS PLATE THREE DAYS AGO, IT WAS FELT THAT RE-ENFORCEMENT SHOULD BE DONE POSTERIORLY AND THE TISSUE WAS REMOVED LATERALLY BETWEEN THE TRANSVERSE PROCESSES OF L5 AND THE SACRAL ALA AND THE LATERAL GUTTERS USED WERE THEN CURETTED AND CLEANED AND SCRAPED AWAY. DECORTICATION WAS DONE. BMP WITH MASTERGRAFT WERE TAKEN AND PLACED OUT LATERALLY IN THE GUTTERS BETWEEN L5 AND S 1¿¿ NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2009 THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE PATIENT WAS TO USE A BRACE FOR AMBULATION. ON (B)(6) 2009 THE PATIENT PRESENTED WITH PAIN AND UNDERWENT A LUMBAR SPINE CT WHICH DEMONSTRATED FUSION AND INSTRUMENTATION AT L5-S1. THERE WAS A SLIVER OF BONE IN THE LEFT ANTERIOR CANAL JUST POSTERIOR TO THE UPPER MARGIN OF S1 WHICH COULD HAVE BEEN PRODUCING PRESSURE ON THE SACRAL ROOT. THERE WAS ALSO MINIMAL PROTRUSION OF THE LEFT SCREW INTO THE CANAL. ON (B)(6) 2010 THE PATIENT PRESENTED WITH INTENSE PAIN IN NECK, STIFFNESS IN NECK, TOP OF SHOULDER AND DOWN THE RIGHT ARM AS WELL AS PAIN IN BACK AND SPASMS IN HIPS AND DOWN RIGHT LEG. THE PATIENT STATED THIS LAST PAIN WAS ALMOST THE SAME AS BEFORE THEIR SURGERY. X-RAYS OF THE LUMBAR SPINE WERE TAKEN WHICH SHOWED A SOLID L5-S1 EFFUSION. A MRI OF THE LOWER BACK REVEALED A LOT OF ARTIFACT AND WHAT MAY HAVE BEEN DEGENERATIVE DISC DISEASE ABOVE THE PREVIOUSLY FUSED LEVELS. ON (B)(6) 2010 THE PATIENT PRESENTED WITH SEVERE PAIN IN BACK, RIGHT THIGH, NECK AND SHOULDERS. A PREVIOUS MRI HAD SHOWN A LOT OF ARTIFACT WHICH MAY HAVE REPRESENTED DEGENERATIVE DISC DISEASE AT C5-6 AND C6-7 WITH POSSIBLE DISC OSTEOPHYTE COMPLEXES AND SUBLIGAMENTOUS PROTRUSION. THE PATIENT REPORTED THAT PRIOR TO THE MVA THEY HAD NEVER HAD PROBLEMS WITH NECK OR SHOULDERS. ON (B)(6) 2010 THE PATIENT PRESENTED WITH WORSENING PAIN. THE PATIENT REPORTED THAT PHYSICAL THERAPY HAD NOT HELPED AT ALL AND THEY HAD CONTINUED DISCOMFORT IN THE NECK, RIGHT SHOULDER, AND RIGHT ARM AS WELL AS BACK, RIGHT HIP AND RIGHT LEG. ON (B)(6) 2010 THE PATIENT PRESENTED WITH WORSENING BACK, RIGHT HIP, RIGHT LEG, NECK, AND SHOULDER PAIN. THE PATIENT REPORTED THAT THEY HAD BEEN DOING VERY WELL UNTIL A MVA ON (B)(6) 2009. THE PATIENT UNDERWENT A CERVICAL/THORACIC/AND LUMBAR MYELOGRAPHY. RESULTS LUMBAR: MILD DISC BULGES AT L5-S1. RESULTS CERVICAL: SPONDYLOLISTHESIS WITH POSTERIOR DISPLACEMENT OF THE CORD AND NARROWING OF THE SAC AT C5-6 AND C6-7 LEVELS. IN AN ADDENDUM TO THIS REPORT IT WAS REPORTED THAT MYELOGRAPHY REVEALED A FRAGMENTED INTERBODY FUSION BONE GRAFT AT L5-S1. NO DETERMINATION OF THE SOLIDITY OF FUSION COULD BE MADE. THERE WAS AN INCIDENTAL NOTE MADE ON THE REMOTE SCREW HOLES IN THE L5 AND S1 PEDICLES. IT WAS RECOMMENDED THAT THE PATIENT UNDERGO AN EMG NERVE CONDUCTIVE STUDY. ON (B)(6) 2010 THE PATIENT PRESENTED WITH SEVERE PAIN IN BACK, RIGHT BUTTOCKS, RIGHT GROIN, FRONT OF LEG, AND DOWN THE BACK OF HIP. THE PATIENT WAS IN TEARS. THERE WAS MARKED MIDLINE TENDERNESS AND BILATERAL PARAVERTEBRAL SPASM WITH TENDERNESS. THERE WAS PAIN ON PALPITATION OF BOTH BUTTOCKS; SCIATIC NOTCH DISCOMFORT ON THE RIGHT; AND RIGHT SIDE FOOT DROP. THE PATIENT REPORTED GOING TO THE ER (ON THE DOCTOR¿S RECOMMENDATION) OVER THE WEEKEND AND RECEIVING AN INJECTION FOR PAIN. THE PATIENT WAS PRESCRIBED PERCOCET, MEDROL DOSEPAK, AND A MUSCLE RELAXANT. ON (B)(6) 2010 THE PATIENT PRESENTED WITH SEVERE LOW BACK AND BILATERAL LEG PAIN THE PATIENT UNDERWENT AN EMG NERVE CONDUCTIVE STUDY WHICH SHOWED A NORMAL EMG OF BOTH LEGS THOUGH A FULL INTERFERENCE PATTERN WAS NOT SEEN ON NEEDLE STUDY SECONDARY TO PAIN. ON (B)(6) 2010 THE PATIENT PRESENTED WITH WORSENING SEVERE AXIAL BACK PAIN; RIGHT > THAN LEFT HIP PAIN; AND BASELINE NECK PAIN. PER THE ENCOUNTER NOTES THAT PATIENT HAD BEEN SEEN IN ER SEVERAL TIMES SINCE THEIR LAST VISIT. IT WAS NOTED THAT THE PATIENT HAD A KNOWN FRACTURE OF THE FEMORAL ALLOGRAFT USED IN THEIR ALIF SURGERY. IN ADDITION THE PATIENT HAD DEVELOPED OSTEOPHYTIC SPURRING. ¿THIS ALL STEMS FROM A CAR WRECK.¿ IT WAS RECOMMENDED THAT THE PATIENT UNDERGO SURGERY TO REMOVE THE ANTERIOR PLATE AND FRACTURED ALLOGRAFT; PLACEMENT OF A UNIPLATE ANTERIORLY; AND THEN UNDERGO A POSTEOLATERAL ARTHRODESIS WITH 3DX GUIDANCE (DUE TO DISTORTED ANATOMY). THE PATIENT WAS PRESCRIBED OXYCONTIN FOR THE SHORT TERM. ON (B)(6) 2010 THE ¿PATIENT PRESENTED WITH FRACTURE OF THE FEMORAL RING ALLOGRAFT; POSSIBLE PLATE AND SCREW SHIFT TOWARD THE CANAL WHERE NERVE ROOT STARTS; OSTEOPHYTIC SPURRING AND COMPLAINED OF PAIN IN BACK WITH SPASMS IN LEFT HIP AND DOWN THE RIGHT HIP INTO THE LEG. ON (B)(6) 2010 THE PATIENT PRESENTED WITH PAIN AND ALIF HARDWARE FAILURE WITH PSEUDARTHROSIS. THE PATIENT UNDERWENT SURGERY WHICH C ONSISTED OF AN EXPLORATION OF ANTERIOR LUMBAR INTERBODY FUSION WITH REMOVAL OF ANTERIOR INSTRUMENTATION L5-S1, ARTHRODESIS WITH ALLOGRAFT L5-S1, AND ANTERIOR INSTRUMENTATION. THIS WAS FOLLOWED BY A L5-S1 POSTERIOR NONSEGMENTAL INSTRUMENTATION. IT SHOULD BE NOTED THAT WHILE OBTAINING RETROPERITONEAL ACCESS TO THE L5-S1 DISC SPACE, SEVERAL DENSE ADHESIONS BETWEEN THE LEFT COMMON ILIAC VEIN AND THE HARDWARE WERE NOTED. THESE WERE CAREFULLY DISSECTED OFF. SEVERAL SMALL HOLES WERE PLACED IN THE LILAC VEIN AND THESE WERE CLOSED OFF THEN THE HARDWARE WAS REMOVED AND NEW HARDWARE PLACED¿.¿ IT SHOULD ALSO BE NOTED PER THE OPERATIVE REPORT: ¿¿ONCE THE L5-51 PRIOR MEDTRONIC PYRAMID PLATE WAS EXPOSED, THE PLATE WAS REMOVED ALONG WITH THE THREE SCREWS. AFTER REMOVING IT, WE EXPLORED THE L5-51 ARTHRODESIS. THERE WAS A SMALL CHIP OF BONE OFF ON THE RIGHT SIDE THAT WAS REMOVED BUT SURPRISINGLY A LARGE PORTION OF THE MOST ANTERIOR PART OF THE BONE HAD INCORPORATED AND WAS QUITE SOLID. BASED ON THIS, I DID NOT WANT TO TAKE THIS DOWN TO EXPLORE DEEPER INTO THE FUSION MASS AND WE ELECTED TO LEAVE THIS IN PLACE. IN THE GAP TO THE RIGHT SIDE, THERE WAS AN OPENING IN THE DEFT. AN INFUSE BONE WAS PLACED INTO THIS CLEFT INSIDE OF THE PRIOR FUSION MASS. NEXT, A GLOBUS INDEPENDENCE PLATE, SMALL 17 WAS PUT INTO PLACE. HOLES WERE DRILLED, TWO UP AND ONE DOWN, THEN 25 X 5.5 SCREWS WERE PLACED¿¿ C-ARM CONFIRMATION PLACEMENT AND SCREWS STIMULATION SHOWED GOOD NUMBERS .THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2010 THE PATIENT PRESENTED WITH PROGRESSIVELY WORSENING PAIN, VOMITING AND NAUSEA. THE PATIENT REPORTED HEMATEMESIS. ON (B)(6) 2010 THE PATIENT PRESENTED WITH NAUSEA, VOMITING, HEMATEMESIS AND PAIN. THE PATIENT UNDERWENT AN ABDOMINAL AND PELVIC CT WHICH DEMONSTRATED STATUS POST FUSION AT L5-S1 WITH INTRAMUSCULAR AND LEFT RETROPERITONEAL HEMATOMA; RIGHT TRANS-PEDICLE SCREW OF S1 WHICH MAY HAVE BEEN TRAVERSING THE RIGHT S1 NEURAL FOREMAN; EVIDENCE OF A LEFT PARA-MEDIUM INCISION SITE OF THE ANTERIOR ABDOMINAL WALL; SMALL AIR COLLECTION WITHIN THE ANTERIOR BLADDER WHICH WAS FELT TO BE DUE TO PRIOR FOLEY CATHETER PLACEMENT. THERE WAS ALSO A SMALL LEFT PLEURAL EFFUSION IN THE LEFT LUNG BASE. THE PATIENT UNDERWENT LABS WHICH SHOWED A LOW. THE PATIENT RECEIVED 200CC OF BLOOD. ON (B)(6) 2010 THE PATIENT PRESENTED WITH S1 RADICULITIS AND UNDERWENT SURGERY FOR PERCUTANEOUS REMOVAL OF POSTERIOR SEGMENTAL HARDWARE. PER THE INDICATION NOTES IT WAS REPORTED THAT THE PATIENT HAD HAD A ALIF FOLLOWED WITH PERCUTANEOUS L5-S1 INSTRUMENTATION SEVERAL DAYS PRIOR AND THAT DURING A POST SURGICAL WORK-UP FOR LOW HEMOCRIT, IT WAS DETERMINED THAT RIGHT S1 PEDICLE SCREW HAD BROKEN INTO A PRIOR PEDICLE SCREW TRACT ON THAT SIDE. THE PATIENT REQUESTED REMOVAL OF THE HARDWARE AND IT WAS NOTED THAT SINCE THE PATIENT WAS FUSED ANTERIORLY AND HAD LEFT-SIDE PERCUTANEOUS SCREWS THAT REMOVAL WAS REASONABLE. SET SCREWS WERE REMOVED PERCUTANEOUSLY, THEN THE ROD, AND FINALLY TWO PEDICLE SCREWS ON THE RIGHT SIDE. NO PATIENT COMPLICATIONS WERE REPORTED. POST SURGICALLY THERE WAS NO FURTHER NAUSEA AND HEMOCRIT GOOD. ON (B)(6) 2010 THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE PATIENT WAS TO UTILIZE A BRACE FOR AMBULATION. ON (B)(6) 2010 THE PATIENT PRESENTED WITH IMPROVED SYMPTOMS. THE PATIENT STILL HAD PAIN IN THEIR BACK AND RIGHT HIP. THE PATIENT HAD LOST 20 LBS AND WAS FEELING BETTER OVERALL. ON (B)(6) 2011 AN ADDENDUM WAS ADDED TO THE (B)(6) 2010 OFFICE NOTE STATING THAT THE PATIENT¿S RIGHT HIP AND RIGHT LEG WERE SLIGHTLY BETTER. THAT THE PATIENT WAS HAVING ISSUES WITH THEIR NECK. THE PATIENT HAD BEEN ADVISED THAT THERE WAS LITTLE THAT COULD BE DONE FROM A SURGICAL POINT. ON (B)(6) 2011 THE PATIENT PRESENTED WITH DISPLACEMENT OF THE CERVICAL INTERVERTEBRAL DISC FORM C4 TO C7 WITH PAIN IN BOTH SHOULDERS RADIATING INTO BOTH ARMS AND TINGLING IN THE RIGHT HAND. THE PATIENT UNDERWENT A CERVICAL EPIDURAL INJECTION IN THE PROXIMAL INTERFACE C7-T1. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2010 THE PATIENT PRESENTED WITH PAIN AND UNDERWENT A LUMBAR SPINE X-RAY WHICH SHOWED ADDITIONAL HARDWARE PLACEMENT SINCE LAST X-RAY PLACED POSTERIORLY TO THE LEFT OF MIDLINE; BONE GRAFT MATERIAL IN THE INTRA-TRANSVERSE PLANE BILATERALLY; AND ENDPLATE SPURRING. ON (B)(6) 2011 THE PATIENT PRESENTED WITH PAIN AND A HISTORY OF PSEUDOARTHROSIS. THE PATIENT UNDERWENT X-RAYS WHICH SHOWED FUSION AT L5-S1; NO EVIDENCE OF HARDWARE COMPLICATION; ENDPLATE SPURRING THROUGHOUT; AND NORMAL ALIGNMENT. ON (B)(6) 2011 THE PATIENT PRESENTED WITH IMPROVED BACK AND HIP PAIN. THE PATIENT ALSO REPORTED PAIN IN THE NECK AND ACROSS BOTH SHOULDERS, LEFT> RIGHT. IN THE ENCOUNTER NOTES, IT MENTIONED THAT THE PATIENT HAD PREVIOUSLY DEVELOPED PHLEBITIS AND HAD BEEN PLACED ON COUMADIN. ON (B)(6) 2014 THE PATIENT PRESENTED WITH LOW BACK PAIN AND UNDERWENT A SPIRAL CT SCAN ON THE LUMBAR SPINE WHICH DEMONSTRATED ENDPLATE SPURRING; ANTERIOR FUSION AT L5-S1; MILD BILATERAL FACET ARTHROPATHY AT L3-4; BILATERAL FACET ARTHROPATHY AT L4-5; NO DISC HERNIATION OR STENOSIS IDENTIFIED; NO EVIDENCE OF HARDWARE COMPLICATION; AND PARASPINAL SOFT TISSUES WERE REMARKABLE FOR PREVIOUS CHOLECYSTECTOMY CONCLUSION: LUMBAR SPONDYLOLISTHESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393957 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110808AAF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |