INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-04261
- Event Type
- Injury
- Date Received
- November 6, 2014
- Report Date
- October 9, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # M110709AAE AND # M110614AAE. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.
IT WAS REPORTED THAT ON (B)(6) 2007, REPORTEDLY, THE PATIENT UNDERWENT A LUMBAR MRI WHICH DEMONSTRATED ANTEROLISTHESIS OF L3 AND L4 WITH RIGHT-SIDED NEURALFORAMINAL NARROWING AT THE L3-4 LEVEL RELATED TO BOTH HARD AND SOFT DISC ELEMENTS. THERE WAS A SUBARTICULAR AND FORAMINAL STENOSIS PRESENT BILATERALLY. ON (B)(6) 2007, THE PATIENT PRESENTED WITH BACK PAIN (ONSET AS A CHILD), NUMBNESS IN EXTREMITIES, LEG PAIN, INABILITY TO CONCENTRATE, DEPRESSION. ON (B)(6) 2007, THE PATIENT PRESENTED WITH LEFT LOWER BACK AND LEFT HIP PAIN INTO THE LEFT ANTERIOR THIGH DOWN TO THE KNEE WITH SOME LEFT LEG/KNEE NUMBNESS. ON (B)(6) 2007, THE PATIENT PRESENTED WITH BACK AND LEFT LEG PAIN WITH SUSPECTED SPONDYLOLISTHESIS. THE PATIENT UNDERWENT A CT STURDY WHICH SHOWED A DESICCATED L3-4 DISK WITH A GRADE 1-2 SPONDYLOLISTHESIS. THERE WERE BILATERAL PARS INTERARTICULARIS DEFECTS AT L3. AT L4-5 THERE WAS DIFFUSE BULGING WITH A MILD DEGREE OF VENTRAL COMPRESSION AGAINST THE ADJACENT THECAL SAC BUT NO EVIDENCE FOR SPINAL STENOSIS. AT L5-S1, THERE WAS A SLIGHT ANTERIOR SUBLUXATION AND BILATERAL PARS DEFECTS. THE PATIENT UNDERWENT A MRI WHICH DEMONSTRATED ENDPLATE DEGENERATIVE CHANGES AND INTERSPACE DESICCATION AT T6-7 AND T9-1 AND MILD RIGHT MID THORACIC SCOLIOSIS. ON (B)(6) 2007, THE PATIENT PRESENTED WITH A LONG HISTORY OF LOW BACK PAIN WHICH THE PATIENT REPORTED BEGAN WORSENING IN JUNE THE PREVIOUS YEAR WITH PAIN RADIATING INTO THE LEFT HIP, LEFT ANTERIOR THIGH AND LEFT KNEE. THERE WAS NUMBNESS IN THE SAME DISTRIBUTION AND THE PAIN AND NUMBNESS EXTENDING DOWN THE LEFT LEG. PER THE ENCOUNTER NOTES THE PATIENT ALSO HAD SLIGHT ARTHRITIS IN THE LEFT HIP ON (B)(6) 2007, THE PATIENT PRESENTED IN ER WITH SORE THROAT AND UNDERWENT A STREP CULTURE WHICH WAS NEGATIVE. THE PATIENT WAS PLACED ON KEFLEX. ON (B)(6) 2007, THE PATIENT PRESENTED WITH SORE THROAT, THE INABILITY TO SWALLOW VERY EASILY, SORENESS OF THE LYMPH GLANDS BENEATH JAW, AND LOW GRADE FEVER. THE PATIENT HAD A MILD ERYTHEMA OF HER ORAL PHARYNX. THE PATIENT WAS STILL ON KEFLEX. ON (B)(6) 2007, THE PATIENT UNDERWENT A PREOPERATIVE EVALUATION. THE PATIENT WAS NOT CONSIDERED AN ELEVATED RISK FOR CARDIAC COMPLICATIONS. ON (B)(6) 2007, THE PATIENT PRESENTED FOR A FOLLOW-UP ON PHARYNGITIS AND CLEARANCE FOR BACK SURGERY. PER THE ENCOUNTER NOTES, THE PATIENT HAD BEEN SEEN IN URGENT CARE ¿RECENTLY¿ AND PLACED ON ANTIBIOTICS. AT THIS ENCOUNTER IT WAS NOTED THAT THE PATIENT HAD SIGNIFICANTLY IMPROVED AND WAS READY FOR SURGERY. PHARYNGITIS RESOLVED. ON (B)(6) 2007, THE PATIENT PRESENTED WITH PROGRESSIVELY WORSENING LOWER BACK PAIN, PAIN RADIATING INTO THE LEFT BUTTOCK AND LEFT POSTEROLATERAL THIGH,PAIN DOWN INTO LEFT KNEE WITH NUMBNESS IN THE SAME DISTRIBUTION. THE PATIENT ALSO HAD SOME UROLOGIC ISSUES WITH URGENT VOIDING. THE PREOPERATIVE DIAGNOSIS WAS DEGENERATIVE SPONDYLOLISTHESIS GRADE 1 TO 2 L3 ON L4 WITH SUBARTICULAR AND FORAMINAL STENOSIS, BILATERALLY AND SPONDYLOSIS AT L5. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF A LUMBAR INTERBODY ARTHRODESIS, CIRCUMFERENTIAL ARTHRODESIS/360 DEGREE ARTHRODESIS AT THE L3-4 LEVEL WITH IMPLANTATION OF DUAL PEEK 10X26 MM IMPLANTS AT THE L3-4 LEVEL FOLLOWING A RADICAL DISCECTOMY, THEN TAKEDOWN OF THE ZYGAPOPHYSEAL JOINT AND PARS DEFECTS AT L5/DECORTICATION OF THE POSTEROLATERAL SURFACE AND ARTHRODESIS FROM L3 TO S1 FOLLOWED BY SEGMENTAL INSTRUMENTATION. PER THE OPERATIVE NOTES ¿¿ AN INSERTER WAS USED TO ATTACH TO THE PEEK IMPLANT, AND THE 10 X216 PEEK IMPLANT, INTO WHICH WAS PLACED RHBMP2. IT WAS THEN DRIVEN INTO THE DISCKECTOMIZED SPACE ON THE LEFT SIDE AND COUNTERSUNK ABOUT 1MM...IN A SIMILAR FASHION¿WE ATTACHED THE SECOND 10X26 IMPLANT TO AN INSERTER AND DROVE THIS IMPLANT INTO THE DISCKECTOMIZED SPACE AT L3-4 LEVEL.. THIS IMPLANT WAS COUNTER SUNK 1-2MM¿.RHBMP2 CONTAINED IN A COLLAGEN VASCULAR SPONGE WAS THEN PLACED LATERAL TO THE PEDICLE SCREWS AND 6 BURRITOS CONTAINING THE RHBMP2 WERE PLACED LATERAL TO THE CONSTRUCTS¿.¿ NIM SPINE MONITORING WITH A NEUROMUSCULAR EMG OF THE PEDICLE SCREWS WAS UTILIZED DURING SURGERY. IMAGING WAS UTILIZED INTRA-OPERATIVELY FOR VERIFICATION AND PLACEMENT. FOLLOWING SURGERY THE PATIENT WAS NOTED TO HAVE HAD POST OP ANEMIA SECONDARY TO BLOOD LOSS. ESTIMATED BLOOD LOSS 3000CC. CELL SAVER WAS USED WITH 1350 CC OF BLOOD RECOVERED BY THE CELL SAVER. IN ADDITION THE PATIENT RECEIVED ONE UNIT OF PACKED RBC¿S. AT THE TIME OF SURGERY THE PATIENT HAD BEEN GIVEN BLOOD AND POST OP SHE RECEIVED 2 UNITS. PATHOLOGY OF THE LUMBAR DISC L3-4 SHOWED CARTILAGINOUS TISSUE WITH DEGENERATION COMPATIBLE WITH HERNIATED DISC AND FRAGMENTS OF BONE. ON 24 DEC 2007 AND 15 JAN 2007 THE PATIENT UNDERWENT A LUMBOSACRAL CT SCAN WHICH SHOWED INSTRUMENTATION IN GOOD POSITION WITHOUT SIGNS OF FAILURE. AT L3-L4, THERE WERE INTERBODY SPACER ELEMENTS, AND THERE WAS MODEST ANTERIOR SUBLUXATION, PROBABLY ASSOCIATED WITH AN ELEMENT OF PERITHECAL AND PERINEURAL GRANULATION TISSUE. ON (B)(6) 2007, THE PATIENT WAS DISCHARGED FROM HOSPITAL AND TRANSFERRED TO A SHORT TERM REHAB FACILITY. ON (B)(6) 2008, THE PATIENT PRESENTED WITH THE NEW DEVELOPMENT OF TINGLING AND PARESTHESIAS AFFECTING THE LEFT LATERAL THIGH APPEARING IN THE DISTRIBUTION IF THE LATERAL FEMORAL CUTANEOUS NERVE. THE PATIENT WAS UTILIZING THE BRACE AND CANE. THE PATIENT HAD CUT DOWN ON THEIR PAIN MEDICATION. ON (B)(6) 2008, THE PATIENT PRESENTED WITH BACK PAIN AND HYPOTHYROIDISM. THE PATIENT REPORTED SIGNIFICANT IMPROVEMENT IN THE LEFT LEG PAIN SINCE THEIR BACK SURGERY. THE PATIENT CONTINUED TO WEAR A BRACE AND WAS WEANING THEMSELVES OFF OF PAIN MEDICATION. THE PATIENT WAS PARTICIPATING IN PHYSICAL THERAPY AT THIS TIME. MEDICATIONS: OXYCODONE. ON (B)(6) 2008, THE PATIENT PRESENTED WITH IMPROVED STRENGTH AND BALANCE BUT SOME DEGREE OF TINGLING AND PARESTHESIA ALONG THE MEDIAL THIGH. THE PATIENT HAD A VERY SUBTLE LIMP. THE PATIENT REPORTED THAT WHEN THEY GOT TIRED THEIR LEFT FOOT WOULD GIVE OUT AND THAT IF THEY MOVED TO FAST THE LEFT THIGH GOT A SHARP AND THE CONSTANT PAIN. THE PATIENT WAS APPROVED TO RETURN TO PART TIME WORK (4 HOURS A DAY). ON (B)(6) 2008, THE PATIENT UNDERWENT A LUMBAR MRI WHICH SHOWED A 2MM ANTEROLISTHESIS OF L3 ON L4 BUT OTHERWISE ALL ALIGNMENT OF THE SPINE WAS WITHIN NORMAL LIMITS. AT L2-3 THERE WAS A CENTRAL DISC BULGE BUT NO SUBSTANTIAL SPINAL STENOSIS. THERE WAS NO EVIDENCE FOR NEUROFORAMINAL NARROWING AT L2-3. AT L3-4, THERE WAS MODERATE RIGHT AND MILD LEFT NEUROFORAMINAL NARROWING. THE ENHANCEMENT LEVEL AROUND THIS SITE REPRESENTED SCAR TISSUE AND POST-OPERATIVE SURGICAL CHANGE. AT L4-5, THERE WAS A SMALL PARACENTRAL DISC BULGE WITH MODERATE FACET ARTHROPATHY. AT L5-S1 THERE WAS A SMALL LEFT SIDED PARACENTRAL DISC BULGE AND A MILD LEFT FACET ARTHROPATHY. LUMBAR SPINE X-RAYS SHOWED A FRACTURE THROUGH THE NECK OF THE LEFT S1 SCREW. ON (B)(6) 2008, THE PATIENT NOTED THAT THEIR POST-OPERATIVE COURSE HAD BEEN MARKED BY SEVERAL CONDITIONS: THE LEFT LEG REMAINED WEAK EVEN WITH PHYSICAL THERAPY, THE LEFT SIDE LOWER LUMBAR PAIN RADIATING NTO THE UPPER BUTTOCKS; AND PERSISTENT NUMBNESS OVER THE THIGH MUSCULATURE BILATERALLY (PRESENT SINCE THE OPERATION. THERE WAS SOME TENDERNESS ALONG THE LEFT INCISIONAL SCAR LINE.) THE PATIENT HAD A SLIGHT LIMP AND ON THE LEFT SIDE. ASSESSMENT: LEFT-SIDED LOWER BACK AND UPPER GLUTEAL PAIN SECONDARY TO INSTRUMENTATION FAILURE AND BILATERAL L3 DERMATOMAL INVOLVEMENT SECONDARY TO SCAR TISSUE. MEDICATIONS: METHOCARBAMOL AND PERCOCET. ON (B)(6) 2008, THE PATIENT PRESENTED WITH POST LUMBAR FUSION WITH QUESTIONABLE FAILURE. THE PATIENT UNDERWENT A LUMBAR SPINE CT WHICH SHOWED L3 THROUGH S1 POSTOPERATIVE CHANGES; THERE WAS NO DEFINITIVE EVIDENCE FOR HARDWARE LOOSENING OR HARDWARE FAILURE PRESENT. NO LUCENCIES SURROUNDING THE METALLIC ELEMENTS WERE APPRECIATED; POSTERIOR BONE GRAFT MATERIAL AND POSTOPERATIVE CHANGES INCLUDING MILD PERINEURAL AND PERITHECAL GRANULATION TISSUE AT THE L3-L4 AND L4-L5 LEVEL WAS GROSSLY STABLE; THERE WAS NO CENTRAL CANAL STENOSIS OR SIGNIFICANT CHANGE IN THE CALIBER OF THE CENTRAL CANAL PRESENT ON THE CURRENT EXAM. THERE WAS MILD TRIANGULATION OF THE THECAL SAC AT L4-L5, BUT THIS WAS STABLE FROM THE PREVIOUS EXAM; THERE WAS NO ACUTE FRACTURE OR ENDPLATE DEPRESSION; AND L3-L4 INTERBODY SPACER ELEMENTS WITH MINIMAL ANTERIOR SUBLUXATION WERE UNCHANGED FROM THE PREVIOUS EXAM. A NOTE WAS PLACED IN THE FILE OF THIS SCAN THAT, AFTER REVIEW, IT WAS NOTATED THAT THERE WAS A FRACTURE OF THE LEFT S1 PEDICLE SCREW AT ABOUT THE JUNCTION OF THE OUTER THIRD WITH THE MIDDLE THIRD PORTIONS OF THAT SCREW. THERE WAS MINIMAL OFFSET AT THE SCREW FRACTURE. ON (B)(6) 2008, THE PATIENT PRESENTED WITH BACK AND LEFT SIDE HIP TO KNEE PAIN. THE PATIENT REPORTED NOT BEING ABLE TO LAY ON THEIR RIGHT SIDE AND THAT IF THEY LAY ON THE BACK FLAT THEY COULD NOT LIFT THEIR LEFT LEG. THE PATIENT HAD A TENS UNIT FOR HOME USE. MEDICATIONS: ROBOXIN, OXYCODONE, AND LYRICA. ON (B)(6) 2008, APPROX. 15 WEEKS POST OP, THE PATIENT COMPLAINED OF PERSISTENT LEFT LOWER BACK, BUTTOCK, AND LEFT LEG ANTEROLATERAL THIGH PAIN. THE PATIENT COMPLAINED THAT SINCE THE SURGERY THEIR LEFT LEG FELT WEAK. PER THE ENCOUNTER NOTES THE PATIENT HAD HAD A CT STUDY WHICH HAD REVEALED A FRACTURED LEFT S1 PEDICLE SCREW. THE PATIENT STATED THEY COULD FEEL THE INSTRUMENTATION MOVE IN THEIR LOWER BACK WHEN THEY TURNED IN BED. THE PATIENT HAD A SLIGHT LIMP ON THE LEFT SIDE AND A SHORTENED STRIDE. PREVIOUS X-RAYS WERE REVIEWED WHICH SHOWED THE FRACTURE THROUGH THE NECK OF THE SCREW INVOLVING THE LEFT S1 SCREW. A MRI STUDY WAS ALSO REVIEWED WHICH DEMONSTRATED MODERATE RIGHT AND MILD LEFT SIDED NEUROFORAMINAL NARROWING AT L3-4 AND A SMALL PARACENTRAL DISC BULGE AT L4-5. THERE WAS NO EVIDENCE FOR MECHANICAL NERVE ROOT DISPLACEMENT OR COMPRESSION. THE CT SCAN WAS REVIEWED, WHICH THOUGH INITIALLY INTERPRETED AS SHOWING NO INSTRUMENTATION FAILURE, INDEED SHOWED THE LEFT S1 PEDICLE SCREW FRACTURE. ASSESSMENT: THE PATIENT HAD A BILATERAL L3 DERMATOMAL INVOLVEMENT POSSIBLE SECONDARY TO SCAR TISSUE; LEFT SIDE BACK PAIN WITH RADIATION, POSSIBLY PARTIALLY SECONDARY TO INSTRUMENTATION FAILURE. ON (B)(6) 2008, THE PATIENT FILMS WERE REVIEWED IN A NATIONAL CONFERENCE AND IT WAS DISCUSSED THAT THE FRACTURED S1 PEDICLE SCREW WOULD NEED TO BE REPLACED AND SINCE THE S1 PEDICLE WAS RATHER LARGE, THERE WAS A REASONABLE AND EXCELLENT CHANCE THAT A SEPARATE PEDICLE HOLE COULD BE CREATED FOR A MORE SIZABLE S1 PEDICLE SCREW. IT WAS FELT THAT THIS STEP SHOULD BE UNDERTAKEN INITIALLY AS AN INSTR UMENTATION REVISION OPERATION PRIOR TO GOING TO SACROILIAC SCREW FIXATION. ON (B)(6) 2008, THE PATIENT PRESENTED WITH EXTREME PAIN IN THE LOWER BACK, LEFT BUTTOCK AND LEFT POSTEROLATERAL PAIN. REVISION SURGERY WAS DISCUSSED WITH REGARD TO THE PATIENT¿S S1 FRACTURED PEDICLE SCREW. ON (B)(6) 2008, THE PATIENT PRESENTED WITH PAIN LOWER BACK AND LEFT HIP WITH RADIATION TO THE KNEE. THE PATIENT REPORTED THAT BY 12 NOON THE PAIN WAS ¿OVERWHELMING¿ AND THAT THEIR HIP PAIN COULD BE ¿EXCRUCIATING¿. THE PATIENT WAS STILL UTILIZING A CANE AND BRACE. ON (B)(6) 2008, THE PATIENT PRESENTED FOR A SURGICAL CLEARANCE WITH INSTRUMENTATION FAILURE AND CHRONIC PAIN. MEDICATIONS: LYRICA AND VICODIN. PER THE ENCOUNTER NOTES THE ECG AND CHEST X-RAYS FROM NOVEMBER WERE NORMAL. THE PATIENT WAS CLEARED FOR SURGERY. ON (B)(6) 2008, THE PATIENT PRESENTED WITH LOWER BACK AND LEFT LEG PAIN WITH THE PREOPERATIVE DIAGNOSIS OF INSTRUMENTATION FAILURE, SECONDARY TO FRACTURE OF A LEFT S1 PEDICLE SCREW AND LUMBAR RADICULOPATHY ON THE LEFT. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF AN EXPOSURE OF L3 TO S1 WITH: EXPLORATION OF SPINAL FUSION ON BOTH THE RIGHT AND LEFT SIDES; REMOVAL OF SPINAL INSTRUMENTATION, INCLUDING REMOVAL AND RETRIEVAL OF A FRACTURED PEDICLE SCREW ON THE LEFT SIDE AT S1 AND REMOVAL OF A LEFT L5 PEDICLE SCREW. A HEMILAMINECTOMY AT L5 WITH EXPLORATION AND EXPOSURE OF THE LEFT L5 NERVE ROOT AND DISCOVERY OF A CONJOINED NERVE ROOT AT L5 ON THE LEFT; USE OF THE LEICA OPERATING MICROSCOPE; INSTRUMENTATION REPLACEMENT/REVISION WITH SEGMENTAL INSTRUMENTATION AND SPECIFICALLY IMPLANTATION OF A 7.5 X 55. 0 MM SCREW AT THE LEFT S1 PEDICLE SITE ¿ BICORTICAL PENETRATION AND IMPLANTATION OF A 7.5 X 50. 0 MM PEDICLE SCREW AT THE LEFT L5 SITE. NEURO-MONITORING. PEDICLE SCREW STIMULATION WITH SPECIFIC STIMULATION OF THE LEFT L3, L4, L5, AND S1 PEDICLE SCREWS. AND LUMBAR ARTHRODESIS, L3 THROUGH S1 ON THE LEFT SIDE. PER THE OPERATIVE REPORT ¿¿ WE THEN PLACED BONE GRAFT ADD M IXED WITH RHBMP2 ALONG THE GUTTER ON BOTH THE LEFT AN ON THE RIGHT SIDE. WE SUPPLEMENTED OUR FUSION SITE ON THE RIGHT SIDE WITH A BURRITO CONSISTING OF BMP AND MASTERGRAFT AND WE USED THREE ADDITIONAL BURRITOS WITH BMP MASTERGRAFT ON THE PATIENT¿S LEFT SIDE¿¿ NO PATIENT COMPLICATIONS WERE REPORTED. IT SHOULD BE NOTED THAT INTRA-OPERATIVELY ¿¿WHAT WE DISCOVERED NEXT TO OR SUBJACENT TO THIS NERVE ROOT (L5) WAS A SEPARATE SECOND NERVE ROOT JUST OVER THE SUPERIOR ASPECT OF THE SACRAL PEDICLE. THIS NERVE ROOT WAS NOT GOING MEDIAL THROUGH THE PEDICLE WALL BUT LATERAL AND APPEARED TO BE QUESTIONABLY CONJOINED TO THE NERVE ROOT ABOVE AT L5. THERE WAS NOT MUCH OF A CONNECTION, BUT THIS NERVE ROOT WAS CLEARLY PRESENT¿¿ THE PATIENT HAD SOME ANEMIA POST OP AND RECEIVED BLOOD. THE PATIENT ALSO EXPERIENCED SOME PAIN MANAGEMENT ISSUES REQUIRING A PCA PUMP. ON (B)(6) 2008, THE PATIENT WAS ADMITTED TO A MULTIDISCIPLINARY INPATIENT REHAB PROGRAM POST LUMBAR REVISION L2 THROUGH S1 AND REVISION OF OLD HARDWARE. PER THE TRANSFER NOTES ¿¿HER SURGERY WAS SUCCESSFUL IN THAT IT HAS ALLEVIATED THE PAIN AND NUMBNESS AND TINGLING IN THE ANTERIOR LEFT THIGH¿¿ ON (B)(6) 2008, THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2008, THE PATIENT WAS UTILIZING A BRACE AND CANE. THE PATIENT REPORTED THE BRACE WAS STARTING TO FEEL UNCOMFORTABLE. THE PATIENT WAS TO START PHYSICAL THERAPY. ON (B)(6) 2008, THE PATIENT PRESENTED WITH SOME OCCASIONAL LOWER BACK DISCOMFORT AND RESOLVED LEFT LOWER EXTREMITY PAIN. THE PATIENT REPORTED THEY HAD BEEN RELEASED FROM THEIR JOB AND ADVISED TO GO ON LONG TERM DISABILITY. THE PATIENT WAS INTERESTED IN CONTINUING WORK BUT DID NOT FEEL THEY COULD WORK EIGHT HOURS A DAY (SECONDARY TO PAIN ESCALATING BY MIDDAY). LUMBAR SPINE X-RAYS SHOWED GOOD POSITIONING OF PEDICLE SCREWS AND NO SIGN OF INSTRUMENTATION FAILURE. THE PHYSICIAN NOTED THE PATIENT SHOULD BE ON CONTINUED SHORT TERM DISABILITY AND SHOULD NOT GO BACK TO A FULL TIME JOB UNTIL SHE WAS FUNCTIONALLY RECOVERED. ON (B)(6) 2008, THE PATIENT PRESENTED WITH LEFT SIDE LOWER BACK PAIN, WORSE IN THE AM WITH DEEP BUTTOCK PAIN ON THE LEFT. THE PATIENT HAD COMPLETED 5 SESSIONS OF PHYSICAL THERAPY. MEDICATION: PERCOCET, LYRICA AND METHOCARBAMOL. ON (B)(6) 2008, THE PATIENT PRESENTED WITH BACK PAIN. THE PATIENT REPORTED THEY FELT THEY WERE GRADUALLY GETTING BETTER. THE PATIENT WAS BECOMING SLIGHTLY MORE AMBULATORY WITH INCREASED RANGE OF MOTION. ON (B)(6) 2008, THE PATIENT PRESENTED WITH RADICULOPATHY AND UNDERWENT LUMBOSACRAL SPINE X-RAYS SHOWED NO SIGNS OF INSTRUMENTATION FAILURE. THERE WAS EVIDENCE OF LUMBAR SPONDYLOSIS AND SLIGHT ANTEROLISTHESIS OF L3 ON L4 BUT THERE WAS AN IMPLANT AT THAT LEVEL. ON (B)(6) 2008, THE PATIENT PRESENTED WITH MID TO UPPER LUMBAR PAIN IN THE UPPER LIMITS OF THE PATIENT¿S INSTRUMENTATION AS WELL AS LEFT BUTTOCK PAIN. ON (B)(6) 2008, THE PATIENT PRESENTED WITH BACK PAIN. PER THE ENCOUNTER NOTES ANOTHER BACK SURGERY WAS BEING CONSIDERED. THE PATIENT WANTED A LOWER DOSE OF PAIN MEDICATION AS THEY WANTED TO WEAN OFF OF THOSE PAIN MEDICATIONS. THE PATIENT ALSO REPORTED SOME CONGESTION, SINUS PRESSURE, PAIN, POST NASAL DRAINAGE AND COUGH. ASSESSMENT: SINUSITIS ¿ PRESCRIBED CEPHALEXIN; AND BACK PAIN ¿ LYRICA INCREASED, PERCOCET DECREASED. ON (B)(6) 2008, THE PATIENT PRESENTED WITH CHRONIC BACK PAIN. PER THE ENCOUNTER NOTES, A FEW WEEKS PRIOR, THE PATIENT HAD PERFORMED A TWISTING EXERCISE WITH THEIR SHOULDERS AND UPPER BODY AND THIS RESULTED IN THE GENERATION OF ELECTRICAL PAIN INTO THE BUTTOCK AND LEG REGION. THE PAIN WAS VERY SHARP AND THE PAIN "FRANKLY SCARED HER." THE PATIENT NOTED THAT THE PAIN DISAPPEARED WHEN THEY DISCONTINUED THOSE EXERCISES. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN WORKING WITH PAIN MANAGEMENT AND BEEN ABLE TO REDUCE THEIR INTACT OF PERCOCET. ON (B)(6) 2009, THE PATIENT PRESENTED, APPROX. 8 MO. POST OP, WITH SOME RESIDUAL LOWER BACK PAIN. LUMBOSACRAL X-RAYS WERE REVIEWED WHICH SHOWED INTER-TRANSVERSE PROCESS FUSION ON THE RIGHT SIDE AND SOMEWHAT EASILY SEEN ON THE LEFT SIDE AS WELL. THERE WAS NO SIGN OF INSTRUMENTATION FAILURE. IN CONTRADISTINCTION TO THE RADIOLOGISTS REPORT, THE L3-4 DISC WAS NOT DEGENERATING BUT HAS BEEN REPLACED WITH DUAL PEEK IMPLANTS AND THERE WAS ARTHRODESIS GROWING THROUGH THE FENESTRATION OR WINDOW IN THE IMPLANT. AN INTERBODY OSSEOUS FUSION WAS EVOLVING AT L3-4. ON (B)(6) 2009, THE PATIENT PRESENTED WITH A FAMILY HISTORY OF OSTEOPOROSIS AND LOW CALCIUM UPTAKE. THE PATIENT UNDERWENT A DXA BONE DENSITOMETRY SCAN. BONE DENSITY WAS CONSIDERED NORMAL PER WHO CRITERIA. MEDICATIONS: LYRICA AND OXYCODONE. ON (B)(6) 2009, THE PATIENT PRESENTED WITH CHRONIC BACK PAIN. THE PATIENT WANTED TO DISCUSS THE POSSIBILITY THAT THEY MAY HAD ATTENTION DEFICIT DISORDER AS THEY HAD A LONG HISTORY OF NOT BEING ABLE TO FOCUS WITH ADD SYMPTOMS. THE PATIENT WAS ALSO FRUSTRATED THAT THEY HAD NOT BEEN ABLE TO LOSE WEIGHT. THE PATIENT WAS STARTED ON A TRIAL OF FOCALIN FOR ADD. THE PATIENT WAS ON OXYCODONE FOR PAIN. ON (B)(6) 2009, THE PATIENT PRESENTED WITH LOWER BACK AND LEFT BUTTOCK PAIN WITH OCCASIONAL EXTENSION OF PAIN INTO THE LEFT POSTEROLATERAL THIGH. THE PATIENT ALSO REPORTED OCCASIONAL ELECTRICAL TYPE PAIN EXTENDING FROM THE BUTTOCKS IN THE POSTERIOR THIGH. ASSESSMENT: ¿¿CHRONIC LEFT L5 RADICULAR PAIN PROBABLY SECONDARY TO A CONJOINED NERVE ROOT.¿ ON (B)(6) 2009, THE PATIENT PRESENTED WITH LOW BACK PAIN AND UNDERWENT A LUMBAR SPINE MRI WHICH DEMONSTRATED SOME DEGENERATIVE CHANGES AT SEVERAL LEVELS MOST PROMINENTLY AT L5-S1 WHERE BILATERAL FACET DEGENERATION AND MILD ANTEROLISTHESIS RESULTING IN MILD BILATERAL AND SYMMETRIC FORAMINAL NARROWING WAS NOTED. AT NO LUMBAR LEVEL WAS THERE EVIDENCE OF SIGNIFICANT CANAL STENOSIS OR A SIGNIFICANT DEGREE OF FORAMINAL NARROWING. ON (B)(6) 2009, IN A FOLLOW UP TO A STUDY ON 19 JUNE 2009, THE PATIENT PRESENTED WITH PERSISTENT LOW BACK PAIN AND UNDERWENT A LUMBAR SPINE MRI WITH CONTRAST WHICH DEMONSTRATED A CONTIGUOUS BONE MARROW SIGNAL AT THE L3-4 INTERSPACE WHERE CAGE FIXATION WAS NOTED. THERE WAS NO EVIDENCE OF SIGNIFICANT EPIDURAL SCARRING. DEGENERATIVE CHANGES AS NOTED IN THE (B)(6) 2009 STUDY. ON (B)(6) 2009, THE PATIENT PRESENTED WITH SOME DEGREE OF LOWER BACK PAIN. THE PATIENT STATED THAT THE LEFT ANTEROLATERAL LEG PAIN AND NUMBNESS HAD RESOLVED. PER THE ENCOUNTER NOTES, A PREVIOUS MRI HAD SHOWN DEGENERATIVE CHANGES OF THE LUMBAR SPINE MOST PROMINENTLY AT THE L5-S1 LEVEL WHERE THERE WAS SOME BILATERAL FACET DEGENERATION. THERE WAS NO TRUE FORAMINAL NARROWING AT THE L4-5 OR AT THE L5-S1 LEVELS AND THERE WAS NO EVIDENCE FOR NEUROFORAMINAL OR CENTRAL SPINAL STENOSIS AT ANY LEVEL PARTICULARLY THE L3-4 LEVEL WHERE THE PLIF WAS ORIGINALLY PERFORMED. ALSO, PER THE ENCOUNTER NOTES THE PATIENT HAD BEEN TOLD THEY HAD DEGENERATIVE FACET ARTHRITIS AND DEGENERATIVE FACET DISEASE OF THE LUMBAR SPINE AND THAT WOULD BE AN ONGOING ISSUE. MEDICATIONS: OXYCONTIN AND METHOCARBAMOL. ON (B)(6) 2009, THE PATIENT PRESENTED WITH SOME PAIN IN THE UPPER GLUTEAL S1 JOINT WITH SOME PAIN INTO THE LEFT LEG. THE PATIENT REPORTED OCCASIONAL ELECTRICAL SENSATIONS INTO BOTH LEGS WITH CERTAIN TWISTING ACTIVITIES. LUMBAR X-RAYS REVEALED INSTRUMENTATION IN GOOD POSITION AND SOLID BONY ARTHRODESIS EXTENDING FROM L3 TO S1. THERE WAS A SLIGHT FLATTENING OF THE LORDOTIC CURVE OVER THE LEVEL OF FUSION. ON (B)(6) 2010, THE PATIENT PRESENTED WITH BACK PAIN AND UNDERWENT A LUMBAR SPINE MRI WHICH SHOWED POST-SURGICAL CHANGES; NO EVIDENCE OF HARDWARE LOOSENING OR FAILURE; STABLE MILD ANTEROLISTHESIS OF L5 ON S1; AND NO SUBLUXATION OR MAL-ALIGNMENT. THERE WAS SIGNIFICANT STABLE POSTERIOR FACET HYPERTROPHY. X-RAYS OF THE THORACIC SPINE SHOWED MILD DEGENERATIVE DISC DISEASE SCATTERED THROUGHOUT THE THORACIC SPINE WITHOUT SIGNIFICANT DISC SPACE LOSS. ON (B)(6) 2010, THE PATIENT PRESENTED WITH GRADUAL IMPROVEMENT OF LOWER BACK DISCOMFORT AND OCCASIONAL BURNING DISCOMFORT INTO BUTTOCKS AND LEFT LEG. X-RAYS DEMONSTRATED STABILITY TO THE L3-4 ARTHRODESIS WHICH WAS MATURE AND ROBUST. THERE WAS NO EVIDENCE OF SUBLUXATION BUT THERE WAS MILD ANTEROLISTHESIS WHICH WAS STABLE L5 ON S1. A LATERAL BONY ARTHRODESIS WAS WELL VISUALIZED BILATERALLY L3- S1. MEDICATIONS: ROBAXIN, LYRICA AND VICODIN. ON 03 AUG 2010 THE PATIENT PRESENTED WITH CHRONIC RADICULAR AND OCCASIONAL ELECTRICAL PAIN EXTENDING FROM BACK THROUGH THE LEFT BUTTOCKS AND INTO THE LEFT LEG. THE PATIENT WAS RELEASED FOR WORK WITH RESTRICTIONS. ON (B)(6) 2010, THE PATIENT PRESENTED, APPROX. 2.5 YEARS POST OP, WITH OCCASIONAL PAIN FROM BACK THROUGH THE LEFT BUTTOCK AND INTO THE ANTEROLATERAL THIGH ON THE LEFT SIDE. MEDICATIONS: ROBAXIN, LYRICA, AND VICODIN. ON 17 DEC 2009, THE PATIENT PRESENTED WITH CHRONIC BACK PAIN AND CONTINUED WITH PAIN MANAGEMENT FOR THIS. MEDICATIONS: PERCOCET. ON (B)(6) 2010, THE PATIENT PRESENTED WITH CHRONIC BACK PAIN AND ANXIETY. ON (B)(6) 2010, THE PATIENT PRESENTED WITH PAIN. MEDICATIONS: ROBAXIN, LYRICA AND VICODIN. ON (B)(6) 2011, THE PATIENT PRESENTED WITH CHRONIC BACK PAIN RELATED TO PREVIOUS SPINAL SURGERY. THE PATIENT REPORTED FEELING ¿HER THYROID MIGHT BE SLIGHTLY OFF¿ AND WANTED THIS RECHECKED. ON (B)(6) 2011, THE PATIENT PRESENTED WITH A HISTORY OF LEFT SIDED RADICULOPATHY AND UNDERWENT LUMBAR SPINE X-RAYS WHICH SHOWED INS TRUMENTATION INTACT WITHOUT SHADOWING. THERE WAS SOLID BONY ARTHRODESIS SEEN FROM L3 DOWN TO L5-S1. THERE WAS GRADE I ANTEROLISTHESIS OF L5 ON S1. APPEARANCE AND ALIGNMENT OF LUMBAR SPINE WAS STABLE. ON (B)(6) 2011, THE PATIENT PRESENTED WITH IMPROVING LOWER BACK PAIN OVER THE SACRUM AND IMPROVING FUNCTIONALITY. PER THE ENCOUNTER NOTES THE PATIENT HAD SOME HIP ISSUES AND HAD UNDERGONE A BURSAL INJECTION BY ANOTHER PHYSICIAN WITH IMPROVEMENT IN THE LEFT HIP. THE PATIENT ALSO HAD DEVELOPED TENNIS ELBOW AND WAS UTILIZING A SPLINT FOR THIS AND HAD UNDERGONE A STEROID INJECTION TO THE ELBOW. CLINICAL ASSESSMENT: MINIMAL RETROLISTHESIS OF L2 ON L3. ON (B)(6) 2011, THE PATIENT PRESENTED WITH BACK PAIN. THE PATIENT WAS ON REGULAR CHRONIC PAIN MEDICATION AND WANTED A REFILL OF OXYCODONE FOR THEIR OCCASIONAL SEVERE BACK PAIN. PER THE ENCOUNTER NOTES THE PATIENT HAD ALSO RECENTLY BEEN SEEN FOR OTITIS EXTENA. THE PATIENT REPORTED THE EAR PAIN WAS GETTING WORSE AND THEY WERE NOT ABLE TO HEAR ANYTHING OUT OF THAT EAR. THE RIGHT EAR SHOWED SIGNIFICANT EDEMA OF THE CANAL. ON (B)(6) 2012, THE PATIENT PRESENTED WITH A COUGH THAT THEY REPORTED THEY HAD OFF AND ON AGAIN FOR A WEEK. PER THE ENCOUNTER NOTES THIS HAD STARTED OUT AS AN UPPER RESPIRATORY TRACT INFECTION WHICH SETTLED INTO HER CHEST. THE PATIENT HAD OCCASIONAL WHEEZING AND SOME PAIN IN THE RIGHT CHEST WALL. THE PATIENT WAS PRESCRIBED QVAR AND LEVAQUIN. ON (B)(6) 2012, THE PATIENT PRESENTED WITH CHRONIC LOWER BACK PAIN RELATED TO THE FAILED LOW BACK SURGERY AND OCCASIONAL CONSTIPATION SECONDARY TO MEDICATION. THE PATIENT WAS TAKING REGULAR PAIN MEDS FOR THIS AND WAS ON LYRICA FOR NEUROPATHIC PAIN. THE PATIENT FELT THEIR LYRICA DOSAGE WAS NOT STRONG ENOUGH. THE DOSAGE WAS INCREASED. ON (B)(6) 2012, THE PATIENT PRESENTED WITH CHRONIC BACK PAIN. THE PATIENT REPORTED HAVING DROPPED A HEAVY OBJECT ON THEIR LEFT FOOT. THE FOOT WAS SWOLLEN, PAINFUL AND BRUISED. A WALKING BOOT WAS APPLIED. ON (B)(6) 2012, THE PATIENT PRESENTED WITH A HISTORY OF SEVERE CHRONIC LOW BACK PAIN. THE PATIENT ALSO REPORTED AN ABSCESSED TOOTH. MEDICATIONS: OXYCODONE, LYRICA. ON (B)(6) 2013, THE PATIENT PRESENTED WITH BACK MUSCLE SPASMS. MEDICATIONS: CYCLOBENZAPRINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715300 | 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 |