INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-03040
- Event Type
- Injury
- Date Received
- July 7, 2014
- Report Date
- September 21, 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) 2009 THE PATIENT PRESENTED WITH RADIATING RIGHT LOWER EXTREMITY PAIN WITH THE PREOPERATIVE DIAGNOSIS OF SEVERE FORAMINAL STENOSIS L5-S1 SPONDYLOLISTHESIS. THE PATIENT REPORTEDLY UNDERWENT SURGERY THAT CONSISTED OF A L5-S1 TLIF. ON (B)(6) 2009, THE PATIENT REPORTEDLY UNDERWENT SURGERY WHICH CONSISTED OF A POSTERIOR L C5-6 FORAMINOTOMY AND C4-5 ACDF. ON (B)(6) 2010, THE PATIENT PRESENTED WITH LOWER EXTREMITY PAIN IN THE L5 DISTRIBUTION. PRIOR IMAGING HAD SHOWN FORAMINAL NARROWING BILATERALLY AT L5-S1 AND L4-5 EPIDURAL PHLEGMON ANTERIORLY THAT WAS CAUSING BILATERAL RECESS STENOSIS. THE PREOPERATIVE DIAGNOSIS WAS L5-S1 SPONDYLOLISTHESIS WITH BILATERAL FORAMINAL STENOSIS AND L5 RADICULOPATHIES AND L405 EPIDURAL MASS WITH LATERAL RECESS STENOSIS BILATERALLY. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF AN L-5 DECOMPRESSIVE LAMINECTOMY WITH MEDIAL FACETECTOMY; BILATERAL GILL PROCEDURE; AND BILATERAL FORAMINOTOMIES AND DECOMPRESSION OF L5 NERVE ROOT. IT SHOULD BE NOTED THAT PER THE OPERATIVE REPORT THERE WAS SOME DENSE SCAR TISSUE AND BONY OVERGROWTH IN THE LATERAL RECESSES. THESE WERE DISSECTED OUT. THE EPIDURAL PHLEGMON WAS DISSECTED OUT AND SET TO PATHOLOGY. THIS WAS NEGATIVE FOR INFECTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ON (B)(6) 2010, THE PATIENT PRESENTED WITH CONSTANT LOWER BACK PAIN WITH RADIATION TO THE RIGHT LOWER EXTREMITY WITH ASSOCIATED DISC OMFORT/NUMBNESS AND TINGLING. PER THE ENCOUNTER NOTES THE PATIENT HAD RECEIVED TRANSFORAMINALS ESI INJECTIONS TO THE RIGHT L4, L5 AND S1 ROOTS AND S1 JOINT. THE L4 SELECTIVE NERVE BLOCK SEEMED TO HAVE THE MOST SIGNIFICANT EFFECT. THE PATIENT REPORTED CONTINUING TO EXPERIENCE A ¿SNAPPING¿ SENSATION AT TIMES OVER THE RIGHT POSTERIOR HIP IN THE VICINITY OF THE S1 JOINT AND STATED THAT THAT SEEMED TO REPRESENT THE ONSET OF RLE PAIN AT ITS WORST. THERE WAS VERY PAINFUL TENDERNESS OVER THE RIGHT S1 JOINT. THE PATIENT HAD BEEN PRESCRIBED NEURONTIN, PERCOCET, LYRICA, AND OXYCODONE. ASSESSMENT: SPINAL STENOSIS ¿ CERVICAL <(>&<)> LUMBAR; CERVICALGIA; ACQUIRED SPONDYLOLISTHESIS; LUMBAGO; AND SCIATICA. ON (B)(6) 2010, THE PATIENT PRESENTED WITH PERSISTENT PAIN AND REPORTEDLY UNDERWENT A MRI WHICH DEMONSTRATED S/P L5-S1 FUSION WITH C ONTINUED SEVERE RIGHT SIDE FORAMINAL NARROWING WHICH WAS CAUSING DEFORMITY AND COMPRESSION OF THE EXITING RIGHT L5 NERVE ROOT. ON (B)(6) 2010, THE PATIENT PRESENTED WITH CONSTANT LOWER BACK PAIN WITH RADIATION TO THE RIGHT LOWER EXTREMITY WITH ASSOCIATED DISC OMFORT/NUMBNESS AND TINGLING. IT WAS NOTED IN THE ENCOUNTER NOTES THAT THE PATIENT WOULD BE UNDERGOING A RIGHT L5-S1 REMOVAL OF HARDWARE AND COMPLETE FORAMINOTOMY FOR DECOMPRESSION OF THE EXISTING NERVE ROOT. ON (B)(6) 2010, IT IS REPORTED THAT THE PATIENT HAD UNDERGONE A CT AND MRI OF THE LUMBAR SPINE WHICH SHOWED BILATERAL FORAMINAL STENOSIS L5-S1, RIGHT>LEFT; AND LUCENCY OF HARDWARE ON CT SCAN INDICATING CONTINUED INSTABILITY. ON (B)(6) 2010, THE PATIENT PRESENTED WITH RIGHT RADICULAR PAIN WITH THE PREOPERATIVE DIAGNOSIS OF INSTABILITY OF L5-S1 WITH HARDWARE FAILURE AND BILATERAL FORAMINAL STENOSIS L5-S1. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF: REMOVAL OF POSTERIOR INSTRUMENTATION AT L5-S1, INCLUDING PEDICLE SCREWS AND INTERBODY CAGE AT L5-S1; REVISION OF THE FUSION AT L5-S1 TO INCLUDE INTERBODY FUSION AND REVISION ON THE CONTRALATERAL SIDE AS THE CAGE THAT WAS REMOVED WITH PLACEMENT OF AN INTERBODY CAGE AND USE OF INFUSE; REVISION OF POSTERIOR LATERAL FUSION; REVISION OF BILATERAL GILL PROCEDURE WITH BILATERAL COMPLETE FACETECTOMY AND DECOMPRESSION OF EXITING L5 NERVE ROOTS; CEMENT AUGMENTATION OF THE L5 AND S1 PEDICLES BILATERALLY FOR PLACEMENT OF PEDICLE SCREWS. PLACEMENT OF PEDICLES SCREW S (POSTERIOR INSTRUMENTATION, L5-S1 BILATERALLY); USE OF MICROSURGICAL TECHNIQUES REQUIRING THE USE OF AN OPERATING MICROSCOPE; USE OF ALLOGRAFT, USE OF AUTOGRAFT; AND INSERTION OF ON-Q PAIN PUMP. PER THE OPERATIVE REPORT AFTER REMOVAL OF CAGE AND INSTRUMENTATION ¿¿A 33-MM LONG XIA CAGE WAS THEN PACKED WITH AUTOGRAFT AND INFUSED AND INSERTED INTO THE INTERBODY SPACE IN A TRANSVERSE FASHION. SEVERAL ATTEMPTS WERE MADE TO TRY TO GET IT ACROSS THE MIDLINE, BUT THE BEST RESULT WAS GETTING THE CAGE TO THE MIDLINE. THE INTERBODY SPACE WAS THEN PACKED WITH SOME MORE AUTOGRAFT¿.¿ IT SHOULD BE NOTED THAT ON EXTRICATION OF THE ORIGINAL CAGE IT WAS FOUND TO HAVE BEEN POSTERIORLY DISPLACED. NEUROMONITORING AND INTRA-OPERATIVE X-RAYS WERE UTILIZED THROUGHOUT. NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT HAD BEEN DOING WELL UNTIL THAT MORNING WHEN THEY WOKE TO BLOODY SHEETS FROM AN INCISIONAL DISCHARGE. THE PATIENT ALSO REPORTED LOWER BACK PAIN BUT WITH IMPROVED RIGHT LOWER EXTREMITY SYMPTOMS. THE PATIENT WAS PLACED ON A TWO WEEK COURSE OF KEFLEX. ON (B)(6) 2010, REPORTEDLY, THE PATIENT HAD BEEN SEEN IN ER FOR WOUND DISCHARGE. THE PATIENT WAS GIVEN ABSORBENT BANDAGES. ON (B)(6) 2010, THE PATIENT REPORTEDLY PRESENTED FOR A WOUND CHECK. ON (B)(6) 2010, THE PATIENT REPORTED HAVING HAD A LOW GRADE FEVER BUT THAT IT HAD RESOLVED THE DAY BEFORE. THE PATIENT COMPLAINED OF LOWER BACK PAIN AND NUMBNESS / TINGLING IN THE RIGHT LEG. THERE WAS VERY PAINFUL TENDERNESS OVER THE RIGHT S1 AREA. ON (B)(6) 2010, THE PATIENT PRESENTED WITH RESOLVED LOWER EXTREMITY PAIN, IMPROVED LOWER BACK PAIN, MINIMAL INCISIONAL DRAINAGE, AND IMPROVED TENDERNESS TO THE S1 AREA. ON (B)(6) 2010, THE PATIENT PRESENTED MILD LOWER BACK PAIN AND MILD ACHINESS TO THE RIGHT LEG WITH NUMBNESS TO THE RIGHT SHIN. THE PATIENT REPORTED THAT THE INCISION WAS NO LONGER DRAINING BUT WAS ¿ITCHY.¿ ON (B)(6) 2010, THE PATIENT REPORTEDLY UNDERWENT A CT SCAN WHICH SHOWED AN UNCOMPLICATED HARDWARE PLACEMENT AND SPINAL ALIGNMENT. ON (B)(6) 2010, THE PATIENT PRESENTED WITH MILD LOWER BACK PAIN AND MILD ACHINESS TO THE RIGHT LEG WITH NUMBNESS TO THE RIGHT SHIN. ON (B)(6) 2011, THE PATIENT PRESENTED WITH MILD ACHINESS IN RIGHT LEG, NUMBNESS TO THE RIGHT SHIN, AND SOME LEFT SIDED LOW BACK PAIN. ON (B)(6) 2011, THE PATIENT PRESENTED WITH WORSENING SYMPTOMS AND INCREASING PAIN IN THE RIGHT LEG AND LOW BACK. THE PATIENT ALSO DESCRIBES MILD DISCOMFORT TO THE LEFT LEG. IT SHOULD BE NOTED THAT THE PATIENT HAD BEEN DISCHARGED FROM PHYSICAL THERAPY. IMAGING WAS ORDERED. THE PATIENT WAS CONTINUING WITH PERCOCET FOR PAIN. ON (B)(6) 2011, THE PATIENT PRESENTED WITH PAIN AND REPORTEDLY UNDERWENT A LUMBAR MRI WHICH INDICATED INCREASED AMORPHOUS BONE GRAFT AT REVISED L5-S1 INTERBODY FUSION; BILATERAL FORAMINAL NARROWING UNCHANGED ON THE RIGHT AND NEW ON THE LEFT DUE TO A BONY BRIDGE. LUMBAR X-RAYS WERE TAKEN WHICH SHOWED NO MOVEMENT AT L5-S1. A CT OF THE LUMBAR SPINE INDICATED A NEW LEFT L5-S1 FORAMINAL STENOSIS BY BONEY BRIDGE POSTERIOR TO METALLIC MARKER. ON (B)(6) 2011, THE PATIENT PRESENTED WITH INCREASING RIGHT LEG AND LOW BACK PAIN AS WELL AS PROGRESSIVE DISCOMFORT TO THE LEFT LEG. THE PAINT SEEMED LOCALIZED TO THE LATERAL ASPECT OF THE LOWER EXTREMITIES. THE PATIENT STATED THAT THE PAIN WAS PROHIBITING THEM FROM ENJOYING NORMAL ACTIVITIES. ASSESSMENT: ACQUIRED SPONDYLOLISTHESIS, DEGENERATION DISC DISEASE, LUMBAGO, AND DISPLACEMENT OF THE LUMBAR INTERVERTEBRAL DISC WITHOUT MYELOPATHY. THE POSSIBILITY OF A SPINAL CORD STIMULATOR TRIAL WAS DISCUSSED. ON (B)(6) 2011, THE PATIENT PRESENTED WITH CONTINUED PAIN TO THE RIGHT LEG AND LOW BACK AND PROGRESSIVE LEFT LEG DISCOMFORT. THE PATIENT REPORTED PLANNING TO MOVE FORWARD ON A SPINAL CORD STIMULATOR TRIAL. ON (B)(6) 2011, THE PATIENT PRESENTED WITH PAIN AND UNDERWENT LUMBAR SPINE X-RAYS WHICH SHOWED GRADE 1 ANTEROSPONDYLOLISTHESIS AND NO ABNORMAL MOTION. ON (B)(6) 2011, THE PATIENT PRESENTED WITH PAIN TO THE RIGHT > LEFT LOWER EXTREMITIES AND NUMBNESS /TINGLING TO THE LATERAL ASPECT OF THE RIGHT >LEFT EXTREMITIES. IT WAS REPORTED IN THE ENCOUNTER NOTES THAT THE PATIENT HAD UNDERGONE A SPINAL CORD STIMULATOR TRIAL WHICH FAILED. ON (B)(6) 2012, THE PATIENT PRESENTED WITH PAIN AND UNDERWENT A LUMBAR SPINE CT WHICH DEMONSTRATED 2MM RETROLISTHESIS L1-2, AND 3MM AT L2-3 AND L3-4; GRADE 1 ANTEROLISTHESIS AT L5-S1; COMPLETE BONY BRIDGING WAS NOT EVIDENT; L5-S1 CALCIFIC POSTERIOR RIDGE EFFACES THE LEFT NEURAL FORAMEN CONTRIBUTING TO SEVERE FORAMINAL NARROWING; REMOTE COMPRESSION FRACTURE AT L1. LUMBAR X-RAYS WERE ALSO TAKEN WHICH SHOWED NO CHANGES FROM PRIOR STUDY. ON (B)(6) 2012, THE PATIENT PRESENTED WITH RECURRENT AND PERSISTENT LOWER EXTREMITY DISCOMFORT WITH RADIOGRAPHIC EVIDENCE OF RECURRENT FORAMINAL NARROWING AT THE OPERATED LEVEL DUE TO SCARRING AND POSTERIOR BONY OVERGROWTH. PER THE ENCOUNTER NOTES¿¿ IT IS UNLIKELY THIS (PAIN) WILL IMPROVE WITH FURTHER SURGERY¿¿ ON (B)(6) 2012, THE PATIENT UNDERWENT A CERVICAL MRI WHICH INDICATED A DISC PROTRUSION C3-4 WITH MODERATE STENOSIS AND FUSION OF C4-6. ON (B)(6) 2012, THE PATIENT PRESENTED WITH ONGOING LOW BACK AND LOWER EXTREMITY, RIGHT > LEFT, DISCOMFORT. THE PATIENT ALSO REPORTED NECK PAIN WITH RADIATION TO THE RIGHT OCCIPITAL REGION ASSOCIATED WITH HEADACHES. ON (B)(6) 2012, THE PATIENT PRESENTED WITH ONGOING LOW BACK AND LOWER EXTREMITY, RIGHT > LEFT, DISCOMFORT AND NECK PAIN. PER THE ENCOUNTER NOTES THE PATIENT HAD UNDERGONE TWO CERVICAL ESI¿S AND WAS FEELING SOME IMPROVEMENT TO NECK PAIN. ON (B)(6) 2013, THE PATIENT PRESENTED WITH ONGOING LOW BACK AND LOWER EXTREMITY, RIGHT > LEFT, DISCOMFORT AND NECK PAIN. PER THE ENCOUNTER NOTES THAT PATIENT HAD RECEIVED ONE CERVICAL ESI THE WEEK BEFORE WHICH PROVIDE 70-80% INITIAL RELIEF BUT THAT THE SYMPTOMS HAD RETURNED. THE PATIENT COMPLAINED THE NECK PAIN HAD BEEN ONGOING FOR LAST TWO MONTHS WITH ASSOCIATED HEADACHES. THE PATIENT WAS PRESCRIBED RIGHT SIDED S1 JOINT INJECTIONS AND PHYSICAL THERAPY. ON (B)(6) 2013, THE PATIENT PRESENTED WITH LOW BACK PAIN AND BILATERAL LOWER EXTREMITY PAIN WITH NUMBNESS AND TINGLING. THE PATIENT UNDERWENT A LUMBAR MRI WHICH DEMONSTRATED LAMINECTOMY/FUSION L5-S1 WITH UNCHANGED FORAMINAL STENOSIS AND UNCHANGED BILATERAL FORAMINAL STENOSIS L4-5; GRADE 1 ANTERIOR LISTHESIS L5-S1; L1 COMPRESSION FRACTURE WITH SLIGHT RETROPULSION OF THE BONE COMPRESSING THE VENTRAL ASPECT OF THE THECAL SAC. LUMBAR X-RAYS INDICATED STABILITY. ON (B)(6) 2013, THE PATIENT PRESENTED WITH THE PATIENT PRESENTED WITH ONGOING LOW BACK AND LOWER EXTREMITY, RIGHT > LEFT, DISCOMFORT AND NECK PAIN. ON (B)(6) 2013, PER THE ENCOUNTER NOTES, THE PATIENT HAD UNDERGONE AN ESI 3 WEEKS PRIOR WITH SOME RELIEF TO THE PATIENT¿S ¿SCIATICA¿ PAIN. THE PATIENT REPORTED EXPERIENCING A REACTION TO THE INJECTION OF AN UPSET STOMACH FOR THREE WEEKS AFTER THE OCCURRENCE. THE PATIENT COMPLAINED OF TINGLING AND NUMBNESS THROUGHOUT LEGS; WEAKNESS IN LEGS; AND BACK, LEG, AND NECK PAIN. ON (B)(6) 2013, THE PATIENT UNDERWENT A CERVICAL MRI WHICH DEMONSTRATED BILATERAL FORAMINAL STENOSIS C6-7, RIGHT > THAN LEFT; MULTI-LEVEL DEGENERATIVE DISC DISEASE; FORAMINAL NARROWING WAS MOST PRONOUNCED AT C3-4 AND C6-7. ON (B)(6) 2013, THE PATIENT PRESENTED WITH ONGOING BACK AND LOWER EXTREMITY PAIN AND SYMPTOMS AS WELL AS INCREASING NECK PAIN WITH NU MBNESS AND TINGLING TO THE BILATERAL ARMS. THE PARENTHESIS BEGAN 3-4 WEEKS PRIOR.
IT WAS REPORTED THAT ON (B)(6) 2010: PATIENT PRESENTED WITH FOLLOWING PRE-OPERATIVE DIAGNOSIS: L5-S1 SPONDYLOLISTHESIS WITH BILATERAL FORAMINAL STENOSIS AND L5 RADICULOPATHIES; L4-5 EPIDURAL MASS WITH LATERAL RECESS STENOSIS BILATERALLY AND UNDERWENT FOLLOWING PROCEDURES: L4-5 DECOMPRESSIVE LAMINECTOMY WITH MEDIAL FACETECTAMY; THE BILATERAL GILL PROCEDURE; BILATERAL FORAMINOTAMIES AND DECOMPRESSIONS OF L5 NERVE ROOT; USE OF OPERATING MICROSCOPE. THERE WERE NO EVIDENT COMPLICATIONS WITH THE PROCEDURE. ON (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW-UP VISIT DUE TO LOW BACK PAIN. PATIENT DESCRIBES RETURN OF LOW BACK PAIN AND CONTINUES TO EXPERIENCE RADIATION TO THE RIGHT LOWER EXTREMITY WITH ASSOCIATED NUMBNESS/TINGLING. HE CONTINUES TO REPORT A "SNAPPING" SENSATION AT TIMES OVER HIS RIGHT POSTERIOR HIP IN THE VICINITY OF THE SI JOINT AND STATES THIS SEEMS TO REPRESENT THE ONSET OF THE RLE PAIN WHEN AT ITS WORST. HE DOES SAY, HOWEVER, THAT HE HAS CONSTANT RLE PAIN EVEN WITHOUT THE SNAPPING BRINGING IT OD. HE ALSO REPORTS PAIN TO PALPATION OVER THAT AREA WITH EXQUISITE TENDERNESS AND RECREATION OF THE RADIATING PAIN WHEN PALPATED. THERE IS TENDERNESS OVER THE AREA OF THE RIGHT SI JOINT WHICH RECREATES RADIATING PAIN DOWN THE RIGHT LEG AND IS VERY PAINFUL TO EVEN LIGHT PALPATION. ASSESSMENTS: SPINAL STENOSIS IN CERVICAL AND LUMBAR REGION, CERVICALGIA, ACQUIRED SPONDYLOLISTHESIS, LUMBAGO, SCIATICA. ON (B)(6) 2010: PATIENT PRESENTED FOR REVIEW OF HIS NEW MRI AND POSSIBLE SURGICAL INTERVENTION. DIAGNOSTIC STUDIES: LUMBAR MRI ON (B)(6) 2010 RMC - S/P L5-S1 FUSION WITH CONTINUED SEVERE RIGHT SIDED FORAMINAL NARROWING CAUSING DEFORMITY AND COMPRESSION OF THE EXITING RIGHT L5 NERVE ROOT .ASSESSMENTS: SPINAL STENOSIS IN CERVICAL AND LUMBAR REGION, CERVICALGIA, ACQUIRED SPONDYLOLISTHESIS, LUMBAGO, SCIATICA.TREATMENT:1. ACQUIRED SPONDYLOLISTHESIS: PATIENT WILL UNDERGO RIGHT LS-S1 REMOVAL OF HARDWARE AND COMPLETION FORAMINOTOMY FOR DECOMPRESSION OF THE EXITING RIGHT L5 NERVE ROOT. ON (B)(6) 2010: PATIENT WAS ADMITTED TO HOSPITAL. PATIENT PRESENTED WITH FOLLOWING PRE-OPERATIVE DIAGNOSIS: CONTINUED RIGHT RADICULAR PAIN STATUS POST L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION; CONTINUED INSTABILITY, L5-S1, STATUS POST TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH HARDWARE FAILURE; BILATERAL FORAMINAL STENOSIS AT L5-S1. PATIENT UNDERWENT FOLLOWING PROCEDURES: REMOVAL OF POSTERIOR INSTRUMENTATION AT L5-S1 TO INCLUDE REMOVAL OF PEDICLE SCREWS AND INTERBODY CAGE AT L5-S1; REVISION OF THE FUSION AT L5-S1 TO INCLUDE INTERBODY FUSION AND REVISION ON THE CONTRALATERAL SIDE AS THE CAGE THAT WAS REMOVED WITH PLACEMENT OF AN INTERBODY CAGE AND USE OF RHBMP-2/ACS; REVISION OF POSTERIOR LATERAL FUSION; REVISION OF BILATERAL GILL PROCEDURE WITH BILATERAL COMPLETE FACETECTOMY AND DECOMPRESSION OF EXITING L5 NERVE ROOTS; CEMENT AUGMENTATION OF THE LS AND S1 PEDICLES BILATERALLY FOR PLACEMENT OF PEDICLE SCREWS; PLACEMENT OF PEDICLES SCREWS (POSTERIOR INSTRUMENTATION, LS-81, BILATERALLY); USE OF MICROSURGICAL TECHNIQUES REQUIRING THE USE OF AN OPERATING MICROSCOPE; USE OF THE OMNI SONOPET ULTRASONIC BONE DISSECTOR FOR DECOMPRESSION; USE OF ALLOGRAFT; USE OF AUTOGRAFT; INSERTION OF ON-Q PAIN PUMP. INDICATION FOR PROCEDURE: PATIENT UNDERWENT AN L5-S1 TLIF ON (B)(6) 2009 FOR L5-S1 SPONDYLOLISTHESIS RESULTING IN RADIATING RIGHT LOWER EXTREMITY PAIN DUE TO SEVERE FORAMINAL STENOSIS. HE INITIALLY HAD RELIEF OF HIS SYMPTOMS, BUT THEN HAD WORSENED PAIN AND THEREFORE UNDERWENT FURTHER DECOMPRESSION ON (B)(6) 2010 FOR BONY DECOMPRESSION OF THE EXITING NERVE ROOTS BILATERALLY. UNFORTUNATELY, HE CONTINUED TO HAVE LOW BACK PAIN AS WELL AS RADIATING RIGHT LOWER EXTREMITY PAIN. HE DESCRIBED A SNAPPING SENSATION IN HIS RIGHT HIP AND UNDERWENT CT SCANNING AND MRI SCANNING OF THE LUMBAR SPINE WHICH REVEALED CONTINUED BILATERAL FORAMINAL STENOSIS, L5-S1, WITH WORSENING OF STENOSIS ON THE RIGHT. ADDITIONALLY, HE HAD LUCENCY OF HARDWARE ON CT SCAN INDICATING CONTINUED INSTABILITY. PER OP NOTES "....THE INSTRUMENTATION WAS EXPOSED BILATERALLY, AND AT THIS POINT, THE RODS WERE REMOVED BY REMOVING THE SCREW CAPS AND REMOVING THE RODS. EACH OF THE 4 SCREWS WAS ASSESSED, AND THEY WERE ALL FOUND TO BE LOOSE EXCEPT FOR THE RIGHT S1 SCREW. THEY WERE MOBILE WITHIN THE PEDICLES BILATERALLY AT L5 AND ON THE LEFT SIDE AT S1. FOR THIS REASON, THE DECISION WAS MADE TO REVISE ALL 4 PEDICLE SCREWS AND AUGMENT THEIR POSITIONING WITHIN THE BONE WITH HPR BONE CEMENT. BEFORE REPLACING THE PEDICLE SCREWS, HOWEVER, WIDE BILATERAL GILL TYPE PROCEDURES WERE PERFORMED WITH TOTAL FACETECTOMIES BILATERALLY FOR DECOMPRESSION OF THE BILATERAL EXITING NERVE ROOTS. AFTER PERFORMING AN ADEQUATE DECOMPRESSION USING MICROSURGICAL TECHNIQUES AND THE OMNI SONOPET TO HELP CAREFULLY REMOVED BONY TISSUE, FURTHER SCAR NEUROLYSIS WAS PERFORMED MEDIALLY TO BE ABLE TO RETRACT THE CAGE. THIS WAS DONE IN A GRADUAL AND SLOW FASHION IN ORDER TO EXPOSE THE CAGE THAT HAD BEEN INSERTED ON THE RIGHT SIDE AT THE ORIGINAL OPERATION. AFTER THE CAGE WAS EXPOSED, THE DURA WAS RETRACTED MEDIALLY IN ORDER TO DISSECT THE DURA AWAY FROM THE CAGE. IT WAS NOTED THAT THE CAGE WAS POSTERIORLY DISPLACED. AT THIS POINT, ATTENTION WAS TURNED TO REMOVING THE PEDICLE SCREWS FROM ALL 4 POSITIONS. AFTER DOING SO, THEN THE HPR BONE CEMENT WAS PREPARED, AND, IN A SEQUENTIAL FASHION, INJECTED INTO EACH OF THE 4 PEDICLES PRIOR TO INSERTION OF THE SCREWS. THE INTEGRITY OF THE PEDICLES WAS ASSESSED PRIOR TO INJECTING THE CEMENT TO MAKE SURE THERE WERE NO BREACHES IN THE PEDICLES, AND THERE WERE NO BREACHES IN ANY OF THE 4 PEDICLES. AT EACH PEDICLE, A WIDER DIAMETER AND LONGER PEDICLE SCREW WERE INSERTED AFTER THE SUCCESSFUL INSTILLATION HPR BONE CEMENT. THE PURCHASE INTO EACH OF THE PEDICLES WAS VERY STRONG UPON PLACEMENT OF THE CEMENT AND EACH OF THE PEDICLE SCREWS. THIS WAS ALL DONE UNDER NEURAL MONITORING. EACH OF THE 4 PEDICLE SCREWS WAS THEN STIMULATED WITH NEURAL MONITORING, AND THEY ALL STIMULATED TO ACCEPTABLE LEVELS. AFTER THE SUCCESSFUL REPLACEMENT OF PEDICLE SCREWS, THE THECAL SAC WAS RETRACTED AND PROTECTED MEDIALLY USING THE NERVE ROOT RETRACTOR, AND THEN THE CAGE WAS CAREFULLY REMOVED FROM THE INTERBODY SPACE. AFTER LOOSENING AND REMOVING THE CAGE FROM THE INTERBODY SPACE, THE DISK SPACE WAS THEN PREPARED FOR INSERTION OF A NEW INTERBODY SPACER. A 33-MM LONG XIA CAGE WAS THEN PACKED WITH AUTOGRAFT AND RHBMP-2/ACS WERE INSERTED INTO THE INTERBODY SPACE IN A TRANSVERSE FASHION. SEVERAL ATTEMPTS WERE MADE TO TRY TO GET IT ACROSS THE MIDLINE, BUT THE BEST RESULT WAS GETTING THE CAGE TO THE MIDLINE. THE INTERBODY SPACE WAS THEN PACKED WITH SOME MORE AUTOGRAFT. THE RODS WERE REAPPLIED TO THE SCREW HEADS AND CAPS WERE THEN REAPPLIED. THE SCREWS USED WERE THE STRYKER SCREWS. EACH OF THE 4 CAPS WAS THEN TORQUED DOWN TO FINAL TIGHTENING. AT THIS POINT, COPIOUS AMOUNTS OF BACITRACIN IRRIGATION WERE USED TO IRRIGATE OUT THE FIELD. FINAL X-RAYS WERE TAKEN SHOWING GOOD POSITIONING OF HARDWARE. NEXT, THE HIGH-SPEED AIR DRILL WAS USED TO DECORTICATE BONE LATERAL TO THE PEDICLE SCREWS AND THE GUTTERS WERE THEN PACKED WITH ALLOGRAFT AND AUTOGRAFT. AFTER SUCCESSFUL DECOMPRESSION BILATERALLY, THE INCISION WAS THEN CLOSED IN LAYERS. AN ON-Q PAIN PUMP WAS THEN PERCUTANEOUSLY INSERTED WITH CATHETERS BILATERAL TO THE INCISION IN THE SUBFASCIAL LAYER (INTRAMUSCULAR).THERE WERE NO EVIDENT COMPLICATIONS OF THE PROCEDURE. ON (B)(6) 2010: PATIENT WAS DISCHARGED TO HOME. ON (B)(6) 2010: PATIENT PRESENTED FOR WOUND CHECKUP. PATIENT REPORTED THAT TODAY HIS SHEETS WERE FOUND SATURATED FROM A BLOODY DISCHARGE FROM HIS INCISION. HE DESCRIBES LBP BUT DESCRIBES IMPROVEMENT TO RIGHT LOWER EXTREMITY PAIN. HE DOES CONTINUE TO DESCRIBE NUMBNESS/TINGLING TO THE RIGHT LEG. EXAMINATION: GENERAL: THERE IS TENDERNESS OVER THE AREA OF THE RIGHT SI JOINT WHICH RECREATES RADIATING PAIN DOWN THE RIGHT LEG AND IS VERY PAINFUL TO EVEN LIGHT PALPATION. INCISION: CLEAN. SUPERIOR PORTION OF INCISION HEALING. INFERIOR 1-1.5 CM OF WOUND DEHISCENCE WITH SEROSANGUINEOUS DISCHARGE. STAPLES LEFT IN PLACE. ASSESSMENTS: SPINAL STENOSIS IN CERVICAL AND LUMBAR REGION, CERVICALGIA, ACQUIRED SPONDYLOLISTHESIS, LUMBAGO, SCIATICA. ON (B)(6) 2010: PATIENT PRESENTED FOR WOUND CHECK-UP. HE DESCRIBES LBP AND TENDERNESS TO INFERIOR PORTION OF INCISION. EXAMINATION: INCISION: SURGICAL SITE: CLEAN. SUPERIOR PORTION OF INCISION HEALING. INFERIOR 1-1.5 CM OF WOUND WITH GRANULATION TISSUE. NO DRAINAGE. STAPLES REMOVED. ON (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW UP VISIT. HE REPORTED THAT THE INCISION WAS DRAINED MINIMALLY. AP AND LAT X-RAYS SHOW STABLE ALIGNMENT WITH HARDWARE IN GOOD POSITION. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT. HE DESCRIBES MILD ACHINESS TO THE RIGHT LEG WITH NUMBNESS TO THE RIGHT SHIN. HE DESCRIBES MILD LBP. HE REPORTS THE INCISION IS NO LONGER DRAINING AND THE INCISION IS "ITCHY". ON (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW UP VISIT. HE UNDERWENT CT SCAN ON (B)(6) 2010 SHOWING UNCOMPLICATED HARDWARE PLACEMENT AND SPINAL ALIGNMENT. ON (B)(6) 2011: PATIENT PRESENTED FOR FOLLOW UP VISIT. ON (B)(6) 2011: PATIENT PRESENTED FOR FOLLOW-UP VISIT. SYMPTOMATICALLY PATIENT SEEMS TO BE WORSENING AGAIN WITH INCREASED PAIN TO THE RIGHT LEG AND LOW BACK. HE ALSO DESCRIBES MILD DISCOMFORT TO THE LEFT LEG. ON (B)(6) 2011: PATIENT UNDERWENT X-RAYS OF LUMBAR SPINE (AP/LAT FLX AND EXT). FINDINGS: PEDICLE SCREWS AND FUSION RODS AT L5-S1 AGAIN I DENTIFIED. MILD ANTEROLISTHESIS L5-S1 AGAIN IDENTIFIED AND UNCHANGED. NO DEFINITE MOTION DURING FLEXION OR EXTENSION. MODERATE COMPRESSION FRACTURE OF L1 AGAIN IDENTIFIED. DISC SPACE LOSS T12-L1 AGAIN IDENTIFIED. DISC SPACE LOSS L2-L3 IS MILD LAND AGAIN IDENTIFIED. PATIENT UNDERWENT LUMBAR MRI WITH AND WITHOUT CONTRAST WITH INDICATION OF STATUS POST TLIF REDO. IMPRESSIONS: INCREASED AMORPHOUS BONE GRAFT AT THE REVISED L5-S1 INTERBODY FUSION; SEVERE BILATERAL FORAMINAL NARROWING AT L5-S1. (UNCHANGED ON THE RIGHT, BUT NEW ON THE LEFT DUE TO A BONY BRIDGE POSTERIOR TO A METALLIC MARKER FOR THE DISC GRAFT); UNCHANGED L5-S1 GRADE 1 SPONDYLOLISTHESIS AND POSTERIOR FIXATION. NO MOVEMENT NOTED ON FLEXION-EXTENSION X-RAYS; UNCHANGED L1 COMPRESSION FRACTURE, MILD SUBLUXATIONS, AND FAIRLY MILD FORAMINAL NARROWING AT THE UPPER LUMBAR LEVELS. PATIENT UNDERWENT LUMBAR CT WITHOUT CONTRAST. IMPRESSIONS: INCREASED AMORPHOUS BONE GRAFT AT THE REVISED L5-S1 INTERBODY FUSION; SEVERE BILATERAL FORAMINAL NARROWING AT L5-S1. (UNCHANGED ON THE RIGHT, BUT NEW ON THE LEFT DUE TO A BONY BRIDGE POSTERIOR TO A METALLIC MARKER FOR THE DISC GRAFT); UNCHANGED L5-S1 GRADE 1 SPONDYLOLISTHESIS AND POSTERIOR FIXATION. NO MOVEMENT NOTED ON FLEXION-EXTENSION X-RAYS; UNCHANGED L1 COMPRESSION FRACTURE, MILD SUBLUXATIONS, AND FAIRLY MILD FORAMINAL NARROWING AT THE UPPER LUMBAR LEVELS. ON (B)(6) 2011: PATIENT PRESENTED FOR FOLLOW UP AND REVIEW OF NEW IMAGING STUDIES. PATIENT STATES THE PAIN IS PROHIBITING HIM FROM ENJOYING HIS NORMAL ACTIVITIES. LUMBAR MRI PERFORMED ON (B)(6) 2011 INDICATES INCREASED AMORPHOUS BONE GRAFT AT REVISED L5-S1 INTERBODY FUSION. BILATERAL FORAMINAL NARROWING UNCHANGED ON THE RIGHT, NEW ON LEFT DUE TO BONY BRIDGE. NO MOVEMENT AT L5-S1 ON FLEXION-EXTENSION X-RAYS. LUMBAR CT PERFORMED ON (B)(6) 2011 INDICATES NEW L5-S1 FORAMINAL STENOSIS BY BONY BRIDGE POSTERIOR TO METALLIC MARKER .ASSESSMENTS: ACQUIRED SPONDYLOLISTHESIS, DEGENERATION OF LUMBAR OR LUMBOSACRAL INTERVERTEBRAL DISC, DISPLACEMENT OF LUMBAR INTERVERTEBRAL DISC WITHOUT MYELOPATHY, LUMBAGO. ON (B)(6) 2011: PATIENT UNDERWENT X-RAY OF LUMBAR SPINE (FLEX AND EXT ONLY) .IMPRESSION: NO ABNORMAL MOTION ACROSS L5-S1 FUSION. ON (B)(6) 2012: PATIENT UNDERWENT MRI OF LUMBAR SPINE WITHOUT AND WITH INTRAVENOUS CONTRAST. IMPRESSIONS: PRIOR PLIF AT L5-S1 WITH UNCHANGED GRADE 1 ANTEROLISTHESIS AT THIS LEVEL. THE SPONDYLOLISTHESIS AND POSTERIOR RIDGING ON THE LEFT CONTRIBUTE TO MODERATE TO SEVERE FORAMINAL NARROWING AT THIS LEVEL, LEFT GREATER THAN RIGHT. OTHERWISE, LUMBAR SPONDYLOSIS. REMOTE L1 COMPRESSION FRACTURE. STATUS POST VERTEBROPLASTY AT L5. PATIENT UNDERWENT SINGLE VIEW ORBIT EXAMINATION. SINGLE FRONTAL RADIOGRAPH OF THE ORBITS DEMONSTRATES NO EVIDENCE OF RADIOPAQUE ORBITAL FOREIGN MATTER. PATIENT UNDERWENT X-RAY OF LUMBAR SPINE (AP, LATERAL, FLEXION AND EXTENSION).IMPRESSIONS: NO CHANGE FROM THE PRIOR STUDY ((B)(6) 2011). PATIENT UNDERWENT CT OF LUMBAR SPINE WITHOUT CONTRAST DUE TO STENOSIS AND RADICULOPATHY. IMPRESSION: STATUS POST PLIF AT L5-S1 WITH STABLE ANTEROLISTHESIS AT THIS LEVEL. THE SPONDYLOLISTHESIS AS WELL AS CALCIFIED, POSTERIOR RIDGING ON THE LEFT AT THIS LEVEL CONTRIBUTE TO MODERATE-SEVERE FORAMINAL NARROWING, LEFT GREATER THAN RIGHT. REMOTE COMPRESSION FRACTURE OF L1 PRIOR VERTEBROPLASTY AT L5. OTHERWISE, LUMBAR SPONDYLOSIS. NO SIGNIFICANT CHANGE COMPARED WITH (B)(6) 2011. ON (B)(6) 2012: PATIENT PRESENTED FOR FOLLOW-UP VISIT AFTER MRI/X-RAY. PATIENT HAD SPINAL CORD STIMULATOR TRIAL PERFORMED. FAILURE OF SPINAL CORD STIMULATOR TRIAL. ON (B)(6) 2012: PATIENT UNDERWENT MRI OF CERVICAL SPINE DUE TO PAIN AND SPINAL STENOSIS. CONCLUSION: MEDIUM TO LARGE CRANIALLY DIRECTED CENTRAL DISC EXTRUSION AT C3-C4INDENTS THE VENTRAL SURFACE OF THE CORD AND CAUSES MODERATE TO SEVERE CENTRAL SPINAL STENOSIS. MODERATE BILATERAL NEURAL FORAMINAL NARROWING AT THE SAME LEVEL. INTERVAL INCREASE IN SIZE OF THE DISC EXTRUSION WITH A RESULTING INCREASE IN CENTRAL SPINAL STENOSIS; UNCHANGED MINIMAL CENTRAL SPINAL STENOSIS, MODERATE TO SEVERE RIGHT, AND MODERATE LEFT NEURAL FORAMINAL NARROWING AT C6-C7; NO CONVINCING ABNORMAL CORD SIGNAL AT ANY LEVEL. ON (B)(6) 2012: PATIENT PRESENTED FOR FOLLOW-UP VISIT AFTER PT AND HAS RECEIVED 2 CERVICAL ESI AND DESCRIBES IMPROVEMENT IN NECK PAIN. A SSESSMENTS: ACQUIRED SPONDYLOLISTHESIS; DEGENERATION OF LUMBAR OR LUMBOSACRAL INTERVERTEBRAL DISC; DISPLACEMENT OF LUMBAR INTERVERTEBRAL DISC WITHOUT MYELOPATHY; LUMBAGO; DISPLACEMENT OF CERVICAL INTERVERTEBRAL DISC WITHOUT MYELOPATHY; DEGENERATION OF CERVICAL INTERVERTEBRAL DISC; CERVICALGIA (B)(6) 2012: PATIENT PRESENTED FOR FOLLOW-UP AFTER MRI. PATIENT IS NOW COMPLAINING OF NECK PAIN WHICH HAS BEEN PRESENT FOR THE LAST 2 MONTHS OR SO. HE DESCRIBES RADIATION TO THE RIGHT OCCIPITAL REGION WITH ASSOCIATED HEADACHES. ON (B)(6) 2012: PATIENT PRESENTED FOR FOLLOW-UP AFTER CERVICAL ESI (B)(6) 2013:PATIENT UNDERWENT MRI OF LUMBAR SPINE WITH AND WITHOUT CONTRAST DUE TO LBP AND BILATERAL LOWER EXTREMITY MAIN PAIN, NUMBNESS AND TINGLING. THE PAIN IS WORSE ON THE LEFT. IMPRESSION: POSTERIOR FUSION AT L5-S1 WITH A GRADE 1 ANTERIOR LISTHESIS AT THIS LEVEL. THIS IS WITHOUT CHANGE FROM THE PRIOR EXAM. A POSTERIOR LAMINECTOMY IS PRESENT AT THIS LEVEL. THERE IS NO SIGNIFICANT SPINAL STENOSIS BUT THERE IS BILATERAL NEURAL FORAMINAL COMPROMISE AT THIS LEVEL. ENHANCEMENT IS NOTED IN THE SOFT TISSUES AND AROUND THE THECAL SAC CONSISTENT WITH POSTSURGICAL CHANGE; L1 COMPRESSION FRACTURE WITH SLIGHT RETROPULSION OF THE BONE COMPRESSING THE VENTRAL ASPECT OF THE THECAL SAC. THIS IS UNCHANGED FROM THE PRIOR EXAM. PATIENT UNDERWENT THREE VIEW LUMBAR SPINE X-RAY INCLUDING FLEXION AND EXTENSION. IMPRESSION: POSTERIOR FUSION L5-S1. STABLE WITH NO ABNORMAL MOTION. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW-UP AFTER MRI/X-RAY. HE RETURNS TODAY WITH COMPLAINT OF L>R LOWER EXTREMITY PAIN IN THE LATERAL ASPECT WHICH BEGAN THE BEGINNING OF THIS MONTH. HE DESCRIBES NUMBNESS/TINGLING TO THE LATERAL ASPECT OF THE LOWER EXTREMITIES. DIAGNOSTIC STUDIES: LUMBAR MRI PERFORMED (B)(6) 2013 INDICATES LAMINECTOMY/FUSION L5-S1 WITH UNCHANGED BILATERAL FORAMINAL STENOSIS. UNCHANGED BILATERAL FORAMINAL STENOSIS L4-5. CERVICAL MRI PERFORMED (B)(6) 2012 INDICATES DISC PROTRUSION C3-4 WITH MODERATE STENOSIS. FUSION C4-6. LUMBAR SPINE X-RAYS PERFORMED (B)(6) 2013 IS STABLE WITHOUT EVIDENCE OF INSTABILITY. LUMBAR CT PERFORMED ON (B)(6) 2011 INDICATES NEW L5-S1 FORAMINAL STENOSIS BY BONY BRIDGE POSTERIOR TO METAL ARTIFACT. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW-UP AFTER ESI. PATIENT DOES CONTINUES WITH SOME BILATERAL LEG PAIN ALL THROUGH HIS LEGS LEFT GREATER THAN RIGHT. PATIENT ALSO DID HAVE AN ADVERSE REACTION WITH AN UPSET STOMACH FOR ABOUT 3 WEEKS AFTER HIS INJECTION. HE STATES THAT HIS LEGS FEEL LIKE HE HAS RUN 3-4 MILES ALL THE TIME. PATIENT DOES COMPLAIN OF TINGLING AND SOME NUMBNESS THOUGH OUT HIS LEGS. ON (B)(6) 2013: PATIENT UNDERWENT MRI OF CERVICAL SPINE WITHOUT CONTRAST DUE TO NECK PAIN AND BILATERALLY UPPER EXTREMITY NUMBNESS AND TINGLING. IMPRESSION: MULTILEVEL DEGENERATIVE CHANGES. A DISC PROTRUSION AT C3-C4 HAS DECREASED IN SIZE FROM (B)(6) 2012. OTHERWISE, THERE HAS BEEN NO SIGNIFICANT INTERVAL CHANGE. AS BEFORE, FORAMINAL NARROWING IS MOST PRONOUNCED AT C3-C4 AND C6-C7. THERE IS PERSISTENT MODERATE NARROWING OF THE SPINAL CANAL AT C3-C4. THERE IS NO EVIDENCE OF ABNORMAL SPINAL CORD SIGNAL. ON (B)(6) 2013: PATIENT PRESENTED FOR VISIT DUE TO NECK PAIN. PATIENT COMPLAINS OF INCREASE IN NECK PAIN AS WELL AS NUMBNESS/TINGLING TO THE BILATERAL ARMS. PARESTHESIAS BEGAN APPROXIMATELY 3-4 WEEKS AGO. SYMPTOMS ARE WORSE IN THE RIGHT ARM. DIAGNOSTIC STUDIES: CERVICAL MRI PERFORMED (B)(6) 2013 AT RMC INDICATES BILATERAL FORAMINAL STENOSIS, C6-7, WORSE ON THE RIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 394107 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110908AAF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |