INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-03017
- 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).
(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) 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 (B)(6). 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 PATIENT'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 13(B)(4) 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 POSTEROLATERAL 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) THE PATIENT PRESENTED WITH PAIN AND ALIF HARDWARE FAILURE WITH PSEUDARTHROSIS. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED 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 AN ALIF FOLLOWED WITH PERCUTANEOUS L5-S1 INSTRUMENTATION SEVERAL DAYS PRIOR AND THAT DURING A POST SURGICAL WORK-UP FOR LOW HEMATOCRIT, 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 HEMATOCRIT 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.
IT WAS REPORTED THAT (B)(6) 2008 PATIENT PRESENTED WITH DENERATIVE SPONDYLOSIS, CENTRAL AND FORAMINAL STENOSIS. OPERATION: POSTEROLATERAL FUSION, L5-S1; POSTERIOR LUMBAR DISKECTOMY WITH DECOMPRESSION L5-S1; INSTRUMENTATION L5-S1, SPINAL SYSTEM; POSTEROLATERAL GRAFTING WITH AUTOGRAFT FROM LOCAL BONE; CONTINUOUS NEUROELECTRPHYSIOLOGICAL MONITORING WITH STIMULATION OF THE SCREWS. ON (B)(6) 2008 PREOP DIAGNOSIS: DEGENERATED DISK WITH DISK PROTRUSION, FORAMINAL ENCROACHMENT- L5-S1. OPERATION: POSTLATERAL FUSION L5-S1 BILATERALLY; DECOMPRESSION FORAMINOTOMIES AT L5-S1 BILATERALLY; USING INTERNAL FIXATION L5 TO THE SACRUM; AUTOGRAFT FROM LAMINAR DECOMPOSITION TO BE USED FOR LATERAL FUSION; CONTINUOUS NEURO ELECTRO PHYSICOLOGICAL MONITORING DURING THE ENTIRE CASE; THE DIFFICULTY CODE BECAUSE OF THE SIZE AND DIFFICULTY OF THE PATIENT. PROCEDURE: PARAVERTEBRAL MUSCLES WERE TAKEN DOWN OFF THE SPINOUS PROCESS OF L4, L5 AND THE SACRUM BILATERALLY. X-RAYS WERE TAKEN IDENTIFYING THIS TO BE THE 5-1 INTERSPCAE. BECAUSE OF THIS, WORKING OUT LATERALLY, THE TRANSVERSE PROCESS AND SACRAL ALA WERE IDENTIFIED. THE DEEPEST RETRACTORS HAD TO BE USED FOR THIS. THESE WERE THEN PACKED AWAY WITH SPONGES. DEEP COLLIS RETRACTORS WERE PLACED INTO THE WOUND, OPENING THE SPACE. INTERSPINOUS LIGAMENT BETWEEN L5 AND S1 WAS REMOVED AND INTERTAMINAR SPREADER WAS PUT INTO THE WOUND. WORKING FIRST OF THE LEFT SIDE, THE POSTERIOR HALF OF T HE LAMINA OF L5 WAS REMOVED. LIGAMENTUM FLAVUM WAS IDENTIFIED AND TAKEN DOWN. NERVE ROOT WAS IDENTIFIED AT S1, BUT THERE APPEARED TO BE A LOW TAKE OFF OF THE ROOT AT L5. IN FACT, THE L5 ROOT TRANSVERSED RIGHT OVER THE DISK SPACE ON THE LEFT SIDE. ON THE RIGHT SIDE, DECOMPRESSION WAS DONE SIMILARLY. POSTERIOR HALF OF THE LAMINA, INFERIOR FACET WAS REMOVED. LIGAMENTUM FALVUM WAS TAKEN HOW AND THE SUPERFACIAL FACET OF S1 WAS REMOVED UNTIL THE S1 PEDICLE WAS IDENTIFIED. THE SAME THING WAS FOUND ON THE RIGHT SIDE. THERE WAS A VERY LOW TAKE OFF OF THE L5 ROOT COVERING OVER THE DISK SPACE. ATTEMPTS WERE MADE TO TRY TO MONILIZE THE ROOT, NUT IT WAS VERY DIFFICULT AND AN INTERBODY FUSION WAS FELT TO BE TOO RISKY WITH HIS ANATOMIC ANOMALY. ONCE DECOMPRESSION WAS DONE OF BOTH NERVE ROOTS, THE LONG THIN-BLADE RETRACTORS WERE PLACED INTO THE WOUND FOR BETTER RETRACTION. TRANSVERSE PROCESSES WERE IDENTIFIED AT L5, THE PARS AS WELL AS THE MANIMALLARY PROCESS. SMALL AWL GAINSHIRG. THEY WERE PROBED, THEY WERE TAPPED AND 6.5, 40MM LENGTH SCREWS WERE PASSED INTO THE VERTEBRAL BODY AT L5 BILATERALLY. SAME WAS DONE AT THE SCRUM AND THE MEDIAL WALLS OF THE S1 PEDICLES WERE IDENTIFIED. THE TOP OF THE S1 PEDICLES WERE IDEDTIFIED AND CANNULATION WAS DONE OF S1 PEDICLE ON BOTH SIDES USING STARTING AND GAINSHRIG. THEY WERE PROBED THEY WERE TAPPED AND 7.5MM, 35MM LENGTH SCREWS WERE PASSED INTO THE SACRUM VIA THE S1 PEDICLES. AT THIS POINT, CHECKING WAS DONE OF ALL THE SCREWS AND THEY CHECKED OUT ABOVE THRESHOLD ELECTROPHYSIOLOGICALLY. A 3.0 ROD WAS USED TO CONNECT THE RODS. FOUR SET SCREWS WERE USED TO CONNECT THE RODS. THEY WERE THEN TIGHTENED AND SLIGHT COMPRESSION WAS DONE. THEY WERE TORQUED AND THE SCREW HEADS WERE TORQUED OFF. ONCE THIS WAS DONE, TRANSVERSE PROCESSES WERE DECORTICATED, SACRAL ALA WERE DECORTICATED. LOCAL BONE THAT HAD BEEN TAKEN WAS TAKEN AND PLACED LATERALLY OUT IN THE GUTTERS AS WELL AS BMP AND BONEGRAFT. CORPIOUS IRRIGATION WAS DONE. FLOW SEAL WAS TAKEN AND PLACED OVER THE INTERLAMINAL SPACE. DRAFT WAS LEFT DEEP IN THE CLOSED USING 1-2 AND 2-0 COATED VICRYL AND THE SKIN WAS CLOSED USING WITH THE SURGICAL STAPLES. DRAIN WAS ATTACHED TO THE SKIN IN A ROUTINE FASHION. BECAUSE OF THE SIZE OF THE PATIENT, IT ADDED SIGNIFICANT DIFFICULTY AND TIME TO THE OPERATIVE PROCEDURE. AGAIN AT THE END OF THE CASE, NEURO-ELECTROPHYSIOLOGICAL MONITORING WAS UNREMARKABLE. ON (B)(6) 2008 PATIENT GOT DISCHARGED FROM HOSPITAL. ON (B)(6) 2008 PATIENT PRESENTED DUE TO LOWER BACK PAIN, PAIN IN THE RIGHT LEG AND CALF. PATIENT STARTED HAVING SEVERE PAIN IN HER BACK, RIGHT HIP, RIGHT LEG ALL THE WAY TO THE CALF. OCCASIONALLY, SHE HAD SOME DISCOMFORT ON THE LEFT SIDE BUT THE RIGHT SIDE WAS MUCH WORSE THAN THE LEFT SIDE BUT THE RIGHT SIDE WAS MUCH WORSE THAN THE LEFT. SHE HAD ALSO NOTICED ON OCCASIONAL NUMBNESS IN THE RIGHT LEG. SHE DOES FEEL THERE WAS SOME WEAKNESS IN THE RIGHT LEG MORE SO THAN THE LEFT. WHEN SHE ATTEMPTED TO SIT, STAND OR WALK, ALL OF THIS AGGRAVATES THE PROBLEM AND IT DOES INTERFACE WITH HER SLEEP. SHE DENIED ANY CHANGE IN BOWL OR BLADDER CONTROL. IMPRESSION: LUMBAR DEGENERATED COLLAPSED DISC, L5-S1. BILATERAL FIXATION USING INTERNAL FIXATION L5 TO THE SACRUM; AUTOGRAFT FROM LAMINAR DECOMPRESSION TO BE USED FOR LATERAL FUSION; CANCELLOUS NEURO-ELECROPHYSICOLOGICAL MONITORING DURING THE ENTIRE CASE; THE DIFFICULTY COD, BECAUSE OF THE SIZE AND DIFFICULTY OF THE PATIENT. PROCEDURE: ON (B)(6) 2008 PATIENT PRESENTED FOR FOLLOW-UP DUE TO PAIN IN HER BACK AND LEGS. IMPRESSION: RULE OUT OF HERNIATED DISK. (B)(6) 2009 PATIENT ADMITTED DUE TO TENDERNESS IN THE RIGHT PARAVERTEBRAL REGION IN THE RIGHT SCIATIC NOTCH. IMPRESSION: LOW-BACK PAIN, POSSIBLE PSEUDOARTHROSIS. PATIENT HAD PERSISTENT TO HAD RIGHT BUTTOCKS AND CHECK AND PAIN GOING DOWN THE THIGH. CONCERN WAS THAT THERE COULD BE A PROBLEM WITH THE PEDICLE SCHREW SIFTING AT S1. SHE WILL UNDERGO FURTHER EVALUATION WITH A LUMBAR MYELOGRAM AND POST-MYELOGRAM CT. PHYSICAL EXAMINATION: THERE WAS A MIDLINE SCAR. THERE IS SOME TENDERNESS IN THE RIGHT PARAVERTEBRAL REGION AND RIGHT SCIATIC NOTCH. MOTOR EXAM WAS NORMAL. REFLEXES WERE SYMMETRICAL. IMPRESSION: RIGHT HERNIATED DISK. SCREW DISPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393269 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110711AAA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |