INFUSE BONE GRAFT

MDR report key: 5052375 · Received September 3, 2015

Report

Report Number: 1030489-2015-02181
Event Type: Injury
Date Received: September 3, 2015
Report Date: August 11, 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

Additional Manufacturer Narrative · 1

(B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES RETURNED TO MANUFACTURER FOR EVALUATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2007 THE PATIENT UNDERWENT MRI FOR LUMBAR SPINE. IMPRESSIONS : GRADE 1 SPONDYLISTHESIS L5 ON S1 WITH LEFT SIDED HNP L5-S1. ON (B)(6) 2008 THE PATIENT PRESENTED FOR OFFICE VISIT. IMPRESSIONS: GRADE1 SPONDYLOLISTHESIS L5 ON S1 WITH LEFT SIDED HNP L5-S1. ON (B)(6) 2007 THE PATIENT WAS ADMITTED TO HOSPITAL. ADMITTING DIAGNOSIS: SPONDYLOLISTHESIS L5-S1 WITH DISK HERNIATION. HE UNDERWENT SURGERY. PREOPERATIVE DIAGNOSIS: SPONDYLOLISTHESIS L5-S1; DISK HERNIATION LEFT SIDE L5-S1. MORBID OBESITY. OPERATIVE PROCEDURES: POSTERIOR L5-S1 ARTHRODESIS. POSTERIOR GILL DECOMPRESSION L5. TRANSFORAMINAL LUMBAR INTERBODY FUSION L5-S1. POSTERIOR NON-SEGMENTAL INSTRUMENTATION WITH ZIMMER ST-360. PLACEMENT OF 13MM PEEK INTERBODY SPACERS. 30ML MORSELLIZED ALLOGRAFT CHIPS FOR ARTHRODESIS. FLUOROSCOPY GREATER THAN ON HOUR. PER OP NOTES: A 10MM INCISION WAS MADE IN THE MIDLINE AND BOVIE ELECTROCAUTERY WAS USED TO MAINTAIN HEMOSTASIS. DISSECTION WAS CARRIED OUT OVER THE FACET JOINTS AND THE SACRAL ALA AND TRANSVERSE PROCESS OF L5 WERE IDENTIFIED. THE LEFT SIDE WAS DISSECTED FIRST, FOLLOWED BY THE RIGHT SIDE. THE TRANSVERSE PROCESS AND SACRAL ALA WERE DECORTICATED WITH A LEKSELL RONGEUR PRIOR TO REMOVAL OF THE MAMMILLARY PROCESS. A PROBE WAS THEN USED TO BREECH THE PEDICLE WITH A MALLET USED TO TAP IT THROUGH THE PEDICLE INTO THE VERTEBRAL BODY. A 6.5MM*45MM PEDICLE SCREW WAS PLACED IN L5. 6.5*35MM WAS PLACED IN THE SACRUM, AND THIS WAS ON THE LEFT SIDE. ON THE RIGHT SIDE, A 35MM SACRAL SCREW AND A 40MM L5 SCREW WAS USED. RAY-TEC SPONGES WERE USED TO PACK OUT THE POSTEROLATERAL GUTTERS. THE DISK WAS IDENTIFIED THEN INCISED WITH 15 BLADE KNIFE. GIVEN THE TRIANGULAR SHAPE OF THE L5-S1 DISK, ONCE THE MAJORITY OF THE DISK AS EVACUATED, ALLOGRAFT BONE WHICH HAD BEEN SOAKING IN THE PATIENT¿S BLOOD WAS PLACED INTO L5-S1 INTERSPACE AFTER ML OF NORMAL SALINE IRRIGATION. A 13MM PEEK INTERBODY SPACER WAS THEN IMPACTED INTO THE L5-S1 INTERSPACE. TOO MUCH OF THE BONE WAS PACKED ANTERIORLY AND THE INTERBODY SPACER WAS PROMINENT POSTERIORLY AND THUS HAD TO BE REMOVED THEN RE-IMPACTED AFTER TAKING OUT SOME OF THE GRAFT. GELFOAM WAS PLACED OVER THE ANNULOTOMY DEFECT. THE CONNECTING PLATES WERE AFFIXED TO THE PEDICLE SCREWS IN STANDARD TECHNIQUE USING A POST TO GUIDE THEM OVER. THE REMAINDER OF THE BONE GRAFT, BOTH ALLOGRAFT AND AUTOGRAFT WERE MIXED TOGETHER, DIVIDED AND PLACED OVER THE DECORTICATED TRANSVERSE PROCESSES OF L5 AND THE SACRAL ALA AS A GRAFTING PROCEDURE. H E UNDERWENT C-ARM STUDY OF THE SPINE. IMPRESSIONS: C-ARM FLUOROSCOPY WAS PROVIDED DURING THE POSTERIOR LUMBOSACRAL FUSION. BILATERAL PEDICLE SCREWS AND PROSTHETIC DISC. ON (B)(6) 2007 THE PATIENT WAS DISCHARGED. DISCHARGE DIAGNOSIS: STATUS POST TRANSFORAMINAL LUMBAR INTERBODY FUSION L5-S1. ON (B)(6) 2007 THE PATIENT PRESENTED FOR FOLLOW UP VISIT. IMPRESSIONS: CLINICALLY IMPROVING S/P TLIF L5-S1. ON (B)(6) 2008 THE PATIENT PRESENTED FOR OFFICE VISIT. IMPRESSIONS: CLINICAL IMPROVEMENT IN SOME AREAS; CLINICAL DETERIORATION IN OTHERS; LEFT LEG RADICULOPATHY; POSSIBLE HARDWARE MIGRATION. THE PATIENT ALSO UNDERWENT XRAYS . IMPRESSIONS: LEFT SIDED CAGE MAY BE IMPINGING ON LEFT L5 NERVE ROOT. ON (B)(6) 2008 THE PATIENT UNDERWENT CT SCAN FOR LUMBAR SPINE. IMPRESSIONS: PEEK SPACER APPEAR TO BE POSTERIOR TO THE POSTERIOR CORTEX OF L5. AT L5-S1 NARROWING OF THE ENTRANCE OF THE LEFT NEURAL FORAMEN. THE LEFT L5-S1 NEURAL FORAMEN APPEAR NARROWED DUE TO OSTEOPHYTES FORMATION. INTRAFORAMINAL NERVE IMPINGEMENT WAS CONSIDERED. ON (B)(6) 2008 THE PATIENT PRESENTED FOR OFFICE VISIT. IMPRESSIONS: HW MIGRATION L5-S1 SPACER. ON (B)(6) 2008 THE PATIENT PRESENTED FOR OFFICE VISIT FOR FOLLOW UP. IMPRESSIONS: S/P TLIF L5-S1 CLINICAL DETERIORATION. ON (B)(6) 2008 THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR GRAFT MIGRATION L5-S1, LEFT SIDE. IMPRESSIONS: GRADE 1 GRADE 1 SPONDYLO LISTHESIS L5 ON S1 WITH LEFT SIDED MIGRATION OF PEEK SPACER. REVIEW OF SYSTEMS : NEUROLOGICAL- HEADACHES, WEAKNESS, TINGLING, OR NUMBNESS IN THE LEGS, RESTLESS AT NIGHTS. MUSCULOSKELETAL- BACKACHE. THE PATIENT UNDERWENT SURGERY. PREOPERATIVE DIAGNOSIS: MIGRATION OF L5-S1 INTERBODY SPACER. SPONDYLOLISTHESIS AT L5-S1. PROCEDURE PERFORMED: REMOVAL OF L5- S1 INTERBODY SPACER. REINSERTION OF L5-S1 INTERBODY SPACER. FLUOROSCOPY GREATER THAN 1 HOUR. PER-OP NOTES: DISSECTION WAS CARRIED DOWN ON THE LEFT SIDE ONLY AND THE MEDIAL ASPECT OF THE INSTRUMENTATION WAS IDENTIFIED. AND THEN THE FACET JOINTS WARE EASILY FOLLOWED DOWN TO THE INTERBODY SPACE. THE REAPPEARED TO BE A LARGE AMOUNT OF GRANULATION TISSUE OR DISK MATERIAL WHICH WAS IN THE LS - 51 FORAMEN , AND THIS WAS REMOVED WITH THE PITUITARY RONGEUR. ONCE THE PEEK INTERBODY SPACER WAS IDENTIFIED. IT WAS REMOVED WITH MODERATE DIFFICULTY USING A FREER ELEVATOR TO UNDERMINE ITS SUPERIOR AND INFERIOR SURFACES. THE THREADING DEVICE WAS USED TO ENGAGE THE PEEK INTERBODY SPACER AND THEN ONCE IT WAS LEVERED FREE. IT WAS EASILY REMOVED. THIS INTERBODY SPACER WAS MEASURED FOR ITS SIZE AND HEIGHT , AND A SMALLER AND SHORT INTERBODY SPACER WAS THE N FILLED WITH THE BONE GRAFT WHICH CAME FROM THAT INTERBODY SPACER AND IMPACTED BACK INTO THE LS-51 INTERSPACE ON (B)(6) 2008 THE PATIENT WAS DISCHARGED. DISCHARGE DIAGNOSIS: STATUS POST REVISION GRAFTING INSTRUMENTATION OF L5-S1. ON (B)(6) 2008 THE PATIENT UNDERWENT XRAYS FOR LUMBAR SPINE. IMPRESSIONS: POSTOPERATIVE CHANGE AT L5-S1. MILD DEGENERATIVE CHANGE. ON (B)(6) 2008 THE PATIENT PRESENTED FOR OFFICE VISIT FOR POST-OP FOLLOW UP. IMPRESSIONS: CLINICALLY STABLE ; LEFT LEG RSD AND POSTERIOR MIGRATION OF PEEK SPACER. THE PATIENT ALSO PRESENTED FOR XRAYS. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2008 THE PATIENT PRESENTED FOR XRAYS. POSTSURGICAL CHANGES AT LUMBOSACRAL JUNCTION. OTHERWISE NEGATIVE LEFT HIP. ON (B)(6) 2008 THE PATIENT PRESENTED FOR OFFICE VISIT DUE TO PAIN IN HIS LEFT HIP. IMPRESSION: PATIENT CLINICALLY APPEARS TO BE IMPROVING SLOWLY. ON (B)(6) 2008 THE PATIENT PRESENTED FOR A PROCEDURE. PREOPERATIVE DIAGNOSIS: POST-LAMINECTOMY SYNDROME- LUMBAR. RIGHT-SIDED LUMBAR RADICULOPATHY. PROCEDURES PERFORMED: FLUOROSCOPIC LOCALIZATION AND PLACEMENT OF NEEDLE INTO CAUDAL EPIDURAL SPACE.; INJECTION OF THE CONTRAST TO CONFIRM EPIDUROGRAM. INTERPRETATION OF EPIDUROGRAM; INJECTION OF LOCAL ANESTHETIC AND STEROID INTO THE CAUDAL EPIDURAL SPACE. ON (B)(6) 2008 THE PATIENT PRESENTED FOR OFFICE VISIT DUE TO INJECTION DIDN¿T WORK DUE TO POSSIBLE PINCHED NERVE IN BACK. COMPLICATION: AMBULATION. IMPRESSIONS: PROGRESSIVE LEFT LEG RADICULOPATHY. ON (B)(6) 2008 THE PATIENT PRESENTED FOR A PROCEDURE. PREOPERATIVE DIAGNOSIS: POST-LAMINECTOMY SYNDROME- LUMBAR. RIGHT-SIDED LUMBAR RADICULOPATHY. PROCEDURES PERFORMED: FLUOROSCOPIC LOCALIZATION AND PLACEMENT OF NEEDLE INTO THE LUMBAR.; INJECTION OF THE CONTRAST TO CONFIRM EPIDUROGRAM. INTERPRETATION OF EPIDUROGRAM; INJECTION OF LOCAL ANESTHETIC AND STEROID INTO THE LUMBAR EPIDURAL SPACE AT RIGHT L4-5. ON (B)(6) 2008 THE PATIENT UNDERWENT CT SCAN FOR LUMBAR SPINE. IMPRESSIONS: THE BONE GRAFT MATERIAL DOES NOT APPEAR ENTIRELY INCORPORATED. AT L4-5 THERE WAS A VERY MINIMAL BULGE. AT L5-S1 THERE IS AGAIN NOTED TO BE GRADE1 ANTEROLISTHESIS OF L5 ON S1 WITH RESULTING MILD "PEEUBULGE" OF THE DISC. SURGICAL HARDWARE APPEARED TO BE INTACT. (B)(6) 2008 THE PATIENT PRESENTED FOR OFFICE VISIT. COMPLICATION: PAIN IS CONSTANT. MEDICATIONS REVIEWED. ON (B)(6) 2008 THE PATIENT UNDERWENT XRAYS FOR CHEST. IMPRESSIONS: UNREMARKABLE PA AND LATERAL CHEST. ON (B)(6) 2008 THE PATIENT WAS ADMITTED TO THE HOSPITAL . ADMITTING DIAGNOSIS: PERSISTENT LEFT LEG PAIN. THE PATIENT UNDERWENT A SURGERY. PREOPERATIVE DIAGNOSIS: PSEUDOARTHROSIS AT L5-S1. RETAINED SPINAL INSTRUMENTATION. LEFT LEG RADICULOPATHY MORBID OBESITY. PROCEDURES PERFORMED: REMOVAL OF ST360 FROM THE LEFT SIDE L5-S1. FORAMINAL DECOMPRESSION VIA FACETECTOMY L5-S1. FLUOROSCOPY. PER OP NOTES: DISSECTION WAS CARRIED DOWN ON THE LEFT SIDE ONLY AND THE INSTRUMENTATION WAS EASILY IDENTIFIED AND REMOVED BY UNCOUPLING THE LOCKING NUT AND THEN THE CONNECTING ROD FOLLOWED BY THE PEDICLE SCREWS BEING REMOVED. THE MEDIAL BORDER OF THE FACETS WERE THEN IDENTIFIED AND ISOLATED USING A CURETTE TO SEPARATE IT FROM THE SCAR TISSUE AND AN OSTEOTOME AND A MALLET WERE USED FOR A FACETECTOMY. HARRISON PUNCH RONGEUR WAS USED FOR FURTHER DECOMPRESSION ALONG THE MEDIAL BORDERS OF THE PEDICLES OF L6 AND S1 ON THE LEFT SIDE. FOLLOWING THE S1 PEDICLE DOWN, THE L5-51 DISC SPACE WAS IDENTIFIED AND INCISED WITH AN 11-BLADE KNIFE. A FAR LATERAL DISCECTOMY WAS DONE WITHOUT DIFFICULTY. THE POSTERIOR BORDER OF THE PEAK INTERBODY CAGE WAS VISUALIZED AND FOUND TO BE ANTERIOR TO THE POSTERIOR BORDER OF THE L5 AND S1 VERTEBRAL BODIES AND THUS, WAS LEFT IN PLACE WITHOUT MANIPULATION. THE WOUND WAS THEN IRRIGATED WITH APPROXIMATELY 1000 CC OF NORMAL SALINE. GELFOAM WAS PLACED OVER THE FACETECTOMY SITE. A JACKSON-PRATT DRAIN WAS BROUGHT OUT THROUGH A SEPARATE STAB WOUND INCISION. ON (B)(6) 2008 THE PATIENT PRESENTED FOR OFFICE VISIT FOR POST-OP FOLLOW UP. IMPRESSIONS: CLINICALLY UNCHANGED. ON (B)(6) 2008 THE PATIENT UNDERWENT XRAYS FOR LUMBOSACRAL SPINE. IMPRESSIONS: POSTOP CHANGES OF LS-S1 WITH GRADE1 SPONDYLOLISTHESIS AND FUSION WITH LAMINECTOMIES. NO SIGNIFICANT CHANGE IN ALIGNMENT WITH FLEXION AND EXTENSION APPRECIATED . DEGENERATIVE CHANGES IN THE UPPER LUMBAR SPINE. ON (B)(6) 2008 THE PATIENT PRESENTED FOR OFFICE VISIT DUE TO HURTING IN LOWER BACK ON RIGHT SIDE. IMPRESSIONS: CLINICAL DETERIORATION. ON (B)(6) 2008 THE PATIENT PRESENTED FOR FOLLOW UP WITH SEVERE PAIN IN LEFT LEG. ON (B)(6) 2008 THE PATIENT UNDERWENT XRAYS FOR CHEST. IMPRESSIONS: NEGATIVE PA. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2008 THE PATIENT UNDERWENT A SURGERY. PREOPERATIVE DIAGNOSIS: SPONDYLOLISTHESIS; RADICULOPATHY, LEFT LEG; RETAINED SPINAL INSTRUMENTATION; PSEUDOARTHROSIS; MORBID OBESITY. PROCEDURES PERFORMED: PARTIAL CORPECTOMY OF L5 THROUGH RETROPERITONEAL EXPOSURE. PARTIAL CORPECTOMY OF S1 THROUGH RETROPERITONEAL EXPOSURE. PLACEMENT OF 14 MILLIMETER LORDOTIC PYRAMESH INTERBODY SPACER. ALLOGRAFT CHIPS FOR ARTHRODESIS. REMOVAL OF PEAK INTERBODY SPACER FROM THE L5-S1 INTERSPACE VIA ANTERIOR APPROACH. FLUOROSCOPY GREATER THAN 1 HOUR. PER OP NOTES : ONCE THE L5-51 INTERSPACE WAS CONFIRMED BY IMAGE INTENSIFICATION LATERAL PICTURES A 15 BLADE KNIFE ON A LONG HANDLE WAS USED TO INCISE THE DISC. A FRAGMENT WAS FRACTURED AND REMOVED AND THEN THE REMAINDER OF THE INTERBODY SPACER WAS REMOVED IN TOTAL. ONCE THIS WAS ACCOMPLISHED AN OSTEOTOME AND A MALLET WAS USED TO OSTEOTOMIZE LS AND 51 TO ALLOW FOR FURTHER DECOMPRESSION OF THE EXITING NERVE ROOT AT L5. THIS ALSO EXPOSED BLEEDING BONE FOR THE ARTHRODESIS AND PROVIDED BETTER VISUALIZATION FOR THE POSTERIOR DECOMPRESSION. ONCE THE BLEEDING BONE WAS EXPOSED THE PYRAMESH INTERBODY SPACER WAS MEASURED FOR THE INTERBODY SPACE. ALLOGRAFT BONE WAS SOAKED ON THE BACK TABLE IN NORMAL SALINE AS WELL AS RH-BMP2/ACS. A SPONGE WAS THEN ROLLED WITH SOME OF THE ALLOGRAFT CHIPS IN THE MIDDLE OF IT IN THE BURRITO MANNER AND PLACED IN THE MIDDLE OF THE CAGE. ALLOGRAFT BONE WAS THEN IMPACTED ON BOTH SURFACES OF THE SPONGE SO THAT BONE WOULD BE TOUCHING THE HOST BONE ONCE IMPLANTED. THE WOUND WAS IRRIGATED WITH 500 CUBIC CENTIMETERS OF NORMAL SALINE AND THEN THE PYRAMESH CAGE WAS IMPACTED INTO THE LS-51 INTERSPACE UNDER DIRECT VISUALIZATION. THE SECOND SPONGE WAS ROLLED INTO A CIGAR AND THEN PLACED IN THE PATIENT'S RIGHT LATERAL GUTTER OF THE LS-51 INTERSPACE. THREE ATTEMPTS AT AFFIXING A PLATE TO THE BODIES OF L5 AND S1 WERE ATTEMPTED. ON (B)(6) 2008 THE PATIENT WAS DISCHARGED FROM HOSPITAL. DISCHARGE DIAGNOSIS: STATUS POST ANTERIOR LUMBOSACRAL FUSION WITH INSTRUMENTATION AND BONE GRAFT. ON (B)(6) 2008 THE PATIENT PRESENTED FOR FOLLOW UP VISIT. MEDICATIONS REVIEWED. ON (B)(6) 2008 THE PATIENT PRESENTED FOR OFFICE VISIT. IMPRESSIONS: RS STIMULATOR, ICE TO LOWER BACK. MEDICATIONS REVIEWED. ON (B)(6) 2008 THE PATIENT UNDERWENT XRAYS FOR LUMBAR SPINE. IMPRESSIONS: DEGENERATIVE AND POST-SURGICAL CHANGES. THERE WAS A DEGENERATIVE CHANGES WITH MILD DISC S[ACE NARROWING AT L3-4 AND L4-5, AND THERE WERE SMALL MARGINAL OSTEOPHYTES SEEN THROUGHOUT THE LUMBAR SPINE. THERE WAS SOME DEGENERATIVE CHANGES INVOLVING THE ARTICULAR FACETS FROM L3 THROUGH S1. ON (B)(6) 2008 THE PATIENT PRESENTED FOR FOLLOW UP. IMPRESSIONS: MARKED CLINICAL IMPROVEMENT IN LEG PAIN. ON (B)(6) 2009 THE PATIENT UNDERWENT XRAYS FOR LUMBAR SPINE. IMPRESSIONS: STATUS POST ANTERIOR-POSTERIOR FIXATION AT L5-S1. SLIGHT INCREASE IN ANTEROLISTHESIS OF L5-S1 COMPARED WITH LAST SUDY. ON (B)(6) 2009 THE PATIENT UNDERWENT XRAYS FOR LUMBAR SPINE. IMPRESSIONS: THERE WAS EVIDENCE OF PRIOR FUSION AT THE L5-S1 LEVEL WITH SURGICAL ROD AND PEDICLE SCREWS IN PLACE AS WELL AS A CAGE DEVICE AT L5-S1 LEVEL. MILD DISC SPACE NARROWING IS SEEN AT THE L4-5 LEVEL. ON (B)(6) 2009 THE PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2010 THE PATIENT UNDERWENT XRAYS FOR LUMBAR SPINE. IMPRESSIONS: THE SURGICAL HARDWARE WAS UNCHANGED. SMALL ANTERIOR OSTEOPHYTES WERE NOTED FROM T12 THROUGH L4. ON (B)(6) 2010 THE PATIENT WAS PRESENT FOR MRI OF LUMBAR SPINE. IMPRESSIONS: POST-OPERATIVE CHANGES AT L5-S1. PEDICLE SCREWS WERE IN PLACE ON THE RIGHT AT L5 AND S1 AND THERE IS EVIDENCE OF INTERBODY FUSION. AT L5-S1, THERE IS ANTEROLISTHESIS. THERE IS SEVERE LEFT FORAMINAL NARROWING AND IMPINGEMENT OF THE EXITING LEFT L5 NERVE ROOT, AS WELL AS MODERATE RIGHT FORAMINAL NARROWING. AT L4-5, THERE IS A BROAD-BASED PRODDING DISC WITH MILD TO MODERATE RIGHT AND MILD LEFT FORAMINAL NARROWING. DESICCATION OF THE REMAINING LUMBAR DISCS AND SLIGHT ANNULAR DISC BULGING AT L1-2. ON (B)(6) 2010 THE PATIENT PRESENTED FOR FOLLOW UP VISIT. MEDICATIONS REVIEWED. ON (B)(6) 2010 THE PATIENT PRESENTED WITH LOW BACK LLE PAIN. MRI SHOWED POST-OP CHANGES AT L5-S1 ANTEROLISTHESIS, LEFT FORAMINAL NARROWING AND IMPINGEMENT OF THE EXITING L L5 NERVE ROOT WITH MODERATE R FORAMINAL NARROWING. L4-5 BROAD BASED PROTRUDING DISC, FORAMINAL NARROWING, DISSECTION OF THE REMAINING DISC AND SLIGHT ANNULAR DISC BULGING AT L1-2. DIAGNOSIS: LUMBAR RADICULOPATHY; POST LAMINECTOMY "SYND" LUMBAR. ON (B)(6) 2010 THE PATIENT PRESENTED FOR OFFICE VISIT WITH NO CHANGES AND RATES REMAINING LOW BACK PAIN RADIATING TO LLE AT 8 ON NRS. DIAGNOSIS: LUMBAR RADICULOPATHY; POST LAMINECTOMY SYND LUMBAR. THE PATIENT ALSO PRESENTED FOR A SURGERY. PREOPERATIVE DIAGNOSIS: LUMBAR RADICULOPATHY; POST LAMINECTOMY SYND LUMBAR. PROCEDURE: FLUOROSCOPIC LOCALIZATION AND PLACEMENT OF THE NEEDLE AT LEFT L4-5, L5-S1. INJECTION OF THE CONTRAST TO CONFIRM NEEDLE PLACEMENT. INJECTION OF LOCAL ANESTHETIC AND STEROID TO PERFORM SELECTIVE NERVE ROOT BLOCK AT LEFT L4-5, L5-S1. ON (B)(6) 2010 THE PATIENT UNDERWENT XRAYS FOR LUMBAR SPINE. IMPRESSIONS: NO CHANGE AND COMPLICATION REPORTED. ON (B)(6) 2010 THE PATIENT PRESENTED FOR FOLLOW UP VISIT WITH A PULLING SENSATION IN HIS LOW BACK ON HIS LEFT SIDE. MEDICATIONS WERE REVIEWED. ON (B)(6) 2010 THE PATIENT UNDERWENT XRAYS FOR LUMBAR SPINE. IMPRESSIONS: FUSION AT L5-S1. GRADE1 SPONDYLOLISTHESIS OF L5-S1. ON (B)(6) 2011 THE PATIENT UNDERWENT A SURGERY. PREOPERATIVE DIAGNOSIS: CHRONIC CHOLECYSTITIS. PROCEDURE PERFORMED: LAPAROSCOPIC CHOLESCYSTECTOMY. NO COMPLICATION WAS REPORTED. ON (B)(6) 2012 THE PATIENT UNDERWENT XRAYS FOR LUMBAR SPINE. IMPRESSIONS : POST-SURGICAL CHANGES OF L5-S1 DISCECTOMY WITH ANTERIOR AND RIGHT SIDED POSTERIOR INSTRUMENTATION FUSION. THERE IS GRADE 1 ANTEROLISTHESIS OF L5-S1. MARKED HYPOMOBILITY. MILD L3-L4 AND L4-L5 DISC DEGENERATION. (B)(6) 2012 THE PATIENT PRESENTED FOR FOLLOW UP VISIT. MEDICATIONS WERE REVIEWED. NO COMPLICATION WAS REPORTED. ON (B)(6) 2013 THE PATIENT UNDERWENT XRAYS FOR LUMBAR SPINE. IMPRESSIONS: NO ABNORMAL LUMBAR MOST POST L5-S1 DISCECTOMY AND FUSION PROCEDURE. INTACT RIGHT LATERAL COLUMN INSTRUMENTATION. ON (B)(6) 2013, THE PATIENT PRESENTED FOR OFFICE VISIT FOR FOLLOW UP. NO COMPLICATION WAS REPORTED. ON (B)(6) 2014 THE PATIENT UNDERWENT SURGERY. PREOPERATIVE DIAGNOSIS: SPONDYLOLISTHESIS, SEVERE FORAMINAL STENOSIS, LEFT LEG RADICULOPATHY DUE TO STENOSIS. SURGICAL PROCEDURES: REMOVAL OF LEFT 1.5-S1 FACET JOINT WITH DECOMPRESSION OF NERVE, FLUOROSCOPY GREATER THAN 1 HOUR. PER-OP NOTES : THE IMAGE INTENSIFIER WAS BROUGHT IN AND A METAL SUCKER TIP WAS PLACED OVER THE WOUND AND THEN A 10-BLADE KNIFE WAS USED TO MAKE A 4-CRN INCISION. BOVIE ELECTROCAUTERY WAS CARRIED DOWN IN THE MIDLINE VERY GINGERLY AS HE HAS HAD A GILL LAMINECTOMY AND THERE WAS NOTHING TO PROTECT THE DURA. AFTER THAT STARTED TO ANGLE OUT LATERALLY AND HOPED TO GET TO THE FACET JOINTS. THEN PROBED AND FELT BONE AND THEN DISSECTED THE BONE FREELY BOTH MEDIALLY AND LATERALLY. THE IMAGE INTENSIFIER WAS USED TO FIND THE FACET JOINT AND THEN THIS WAS REMOVED IN A PIECEMEAL FASHION WITH A LEKSELL RONGEUR AND 2 AND 3-MM KERRISON PUNCH RONGEURS. THE DISSECTION WAS CARRIED OUT FAR LATERAL AT LS-SL AND THE NERVE ROOT WAS FOUND TO BE VERY SWOLLEN AND RED AT THE TIME OF DEC OMPRESSION. ONE EPIDURAL BLEEDER WAS COAGULATED WITH THE BIPOLAR ELECTROCAUTERY. GELFOAM WAS PLACED IN THE WOUND UNTIL HEMOSTASIS WAS VERIFIED. THE WOUND WAS THEN IRRIGATED WITH 1000 ML OF NORMAL SALINE. EXPAREL WAS PLACED IN THE PARASPINAL MUSCLES FOR POSTOPERATIVE ANALGESIA AND 1 GRAM OF VANCOMYCIN POWDER WAS PLACED INTO THE PARASPINAL MUSCLES FOR INFECTION PROPHYLAXIS. A JACKSON-PRATT DRAIN WAS BROUGHT OUT THROUGH A SEPARATE STAB WOUND INCISION. ON (B)(6) 2014 THE PATIENT PRESENTED FOR FOLLOW UP VISIT WITH LUMBAR DECOMPRESSION, LOW BACK PAIN LEFT LEG PAIN. MEDICATIONS WERE REVIEWED DURING THE VISIT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
583976	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