INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-03395
- Event Type
- Injury
- Date Received
- August 5, 2014
- Report Date
- July 27, 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)(6). (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 THE PATIENT PRESENTED WITH LOWER BACK PAIN AND HYPERTENSION. THE PATIENT UNDERWENT CHEST X-RAYS WHICH SHOWED NO EVIDENCE OF ACTIVE CARDIAC/PULMONARY DISEASE. THE PATIENT ALSO UNDERWENT A LUMBAR SPINE MRI WHICH DEMONSTRATED MILD POSTERIOR RIGHT PARA-MEDIUM DISC PROTRUSION, L5-S1. ON (B)(6) 2007 THE PATIENT PRESENTED WITH SEVERE CONSTANT LOWER BACK AND RIGHT LEG PAIN. MEDICATIONS: VICODIN AND METHOCARBAMOL. ON (B)(6) 2007 THE PATIENT PRESENTED WITH A 16 YEAR HISTORY OF LOWER BACK PAIN WITH WORSENING RIGHT LEG PAIN AND THE PREOPERATIVE DIAGNOSIS OF DEGENERATIVE DISC DISEASE L5-S1 AND LUMBAR DISC HERNIATION L5-S1. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF A L5-S1 LAMINECTOMY; POSTERIOR LUMBAR INTERBODY FUSION USING BMP CONTAINING SPONGES AND LEOPARD CAGES; AND A POSTEROLATERAL ARTHRODESIS, PEDICLE SCREW STABILIZATION L4-S1 USING (EXPANDING) PEDICLE SCREWS. PER THE OPERATIVE REPORT ¿¿THE END PLATES WERE DECORTICATED AND THEN THE LEOPARD CAGE WAS PACKED WITH BMP CONTAINING SPONGES AND LOCAL AUTOGRAFT AND THEN PLACED IN THE INTERSPACE. THERE APPEARED TO BE A TIGHT FIT. THE TITANIUM RODS WERE THEN REMOVED AND REPLACED AND COMPRESSION WAS CARRIED OUT ACROSS THE PEDICLE SCREWS TO FIRMLY SEAT THE INTERBODY CAGE. AN EPIDURAL CATHETER WAS THEN PLACED AND A CROSSLINK CONNECTOR WAS PLACED AS WELL. THE WOUND WAS THEN IRRIGATED WITH 3 LITERS OF BACITRACIN CONTAINING SOLUTION. AN X-RAY WAS OBTAINED WHICH REVEALED PROPER PLACEMENT OF THE PEDICLE SCREWS AND THE CAGE. THE MEDIUM HEMOVAC DRAIN WAS PLACED AND THEN THIS WOUND WAS THEN IRRIGATED AND THEN TRANSVERSE PROCESSES WERE DECORTICATED AND THE BMP CONTAINING SPONGES AND LOCAL AUTOGRAFT WERE PLACED IN THE POSTEROLATERAL GUTTERS...¿ NO PATIENT COMPLICATIONS WERE NOTED. PATHOLOGY ON THE L5-S1 DISC SHOWED FRAGMENTS OF CARTILAGE WITH CHANGES. ON (B)(6) 2007 THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2007 THE PATIENT PRESENTED WITH SEVERE POST-OPERATIVE WOUND DRAINAGE AND INFECTION. THE PATIENT WAS ADMITTED TO HOSPITAL WHERE THEY UNDERWENT SURGERY WHICH CONSISTED OF INCISION DOWN TO THE SUBFASCIAL PLANE AND DRAINAGE OF THE WOUND. A WOUND CULTURE REVEALED E. COLI. ON (B)(6) 2007 THE PATIENT PRESENTED CONSTANT WOUND DRAINAGE AND LOW GRADE FEVER. ON (B)(6) 2007, WHILE IN HOSPITAL THE PATIENT PRESENTED WITH VENOUS INSUFFICIENCY, CELLULITIS IN THE RIGHT FOOT, AND THE NEED FOR LONG TERM INTRAVENOUS ACCESS FOR ANTIBIOTIC THERAPY. THE PATIENT UNDERWENT SURGERY FOR THE PLACEMENT OF A PICC LINE. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2007 THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2007, IN A TELEPHONE ENCOUNTER, IT WAS REPORTED THAT THE PATIENT WAS HAVING EPISODES OF HOT AND COLD; WAS HARDLY EATING; AND WAS VERY WEAK. THE PATIENT PRESENTED IN AN ER VISIT WITH BACK PAIN AND CHILLS. THE PATIENT UNDERWENT LABS WHICH WERE ABNORMAL. ON (B)(6) 2007 THE PATIENT PRESENTED CONSTANT BACK PAIN. ON (B)(6) 2007 THE PATIENT UNDERWENT LABS WHICH REVEALED LOW HEMOGLOBIN, HEMATOCRIT, NEUT%, UREA NITROGEN, CREATININE, POTASSIUM, B UN/CREAT RATIO AND HIGH PLATELETS, AND EOSINOPHIL. ON (B)(6) 2007 THE PATIENT PRESENTED CONTINUING BACK PAIN, DIARRHEA, AND NAUSEA. PER THE ENCOUNTER NOTES THE PATIENT WAS ADMITTED TO HOSPITAL FOR EVALUATION. ON (B)(6) 2007 THE PATIENT PRESENTED WITH A WOUND INFECTION INVOLVING THE LUMBOSACRAL REGION WITH DRAINAGE, HYPERTENSION, AND INTRACTABLE PAIN. THE PATIENT WAS REPORTED TO HAVE BEEN VOMITING FOR TWO DAYS. THE PATIENT WAS ADMITTED TO HOSPITAL AND CULTURES REVEALED PSEUDOMONAS. THE PATIENT WAS PLACED ON ZOSYN AND AFTER IMPROVEMENT, SWITCHED TO CIPRO. WHILE IN THE HOSPITAL THE PATIENT PRESENTED WITH BLOOD IN URINE. ON (B)(6) 2007 THE PATIENT UNDERWENT LABS WHICH REVEALED LOW POTASSIUM AND CREATININE AND HIGH GLUCOSE. ON (B)(6) 2007 THE PATIENT PRESENTED WITH INFECTION AND DIARRHEA. THE PATIENT UNDERWENT IMAGING FOR A PICC CHECK. THE PATIENT ALSO UNDERWENT A LUMBAR SPINE MRI WHICH DEMONSTRATED ENHANCING SCAR AND GRANULATION TISSUE FILLING THE RIGHT LATERAL RECESS AT L5-S1 AND FUSION HARDWARE AT L5 AND S1. THERE WAS POSTOPERATIVE FLUID COLLECTION WITH THE LARGEST AT THE LEVEL OF THE SUPERIOR S1 PEDICLES AND EXTENDED CONTIGUOUSLY INTO THE DEEP FASCIA PLANE OF THE LOWER BACK, EXTENDING SUPERIORLY AND APPEARED TO DRAIN TO THE SKIN AT THE LEVEL OF L3-4 DISK SPACE. IT EXTENDED CONTIGUOUSLY TO THE LEFT OF THE THECAL SAC AT L5-S1 BUT DID NOT COMPRESS THE THECAL SAC OR RESULT IN STENOSIS. ON (B)(6) 2007 THE PATIENT UNDERWENT THE PLACEMENT OF A PICC LINE FOR LONGTERM ANTIBIOTIC TREATMENT. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2007 THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE PATIENT WAS SENT HOME ON PERCOCET, VALIUM, PRILOSEC, AND CIPRO. ON (B)(6) 2007 THE PATIENT PRESENTED WITH NON-HEALING/SLOW HEALING WOUND TO THE LUMBAR AREA. ON (B)(6) 2007 A WOUND VAC WAS INITIATED TO THE LUMBAR SACRAL REGION. ON (B)(6) 2007 THE PATIENT PRESENTED FOR A WOUND EXAMINATION ¿ WHICH WAS IMPROVING ¿SATISFACTORY¿. ON (B)(6) 2007 THE PATIENT REPORTED LESSENING BACK PAIN AND DID NOT NEED NARCOTIC PAIN MEDICATION ANYMORE. ON (B)(6) 2007 THE PATIENT UNDERWENT LABS WHICH REVEALED LOW HEMOGLOBIN, HEMATOCRIT, UREA NITROGEN, POTASSIUM, CHLORIDE, BUN/CREAT. RATIO, OSMOLALITY AND HIGH WHITE CELL COUNT, PLATELETS, AND GLUCOSE. ON (B)(6) 2007 THE PATIENT REPORTED NO PAIN IN THEIR BACK AND THEY WERE NOT TAKING NARCOTIC PAIN MEDICATION ONLY OCCASIONAL TYLENOL. ON (B)(6) 2007 THE PATIENT PRESENTED WITH A SACRAL WOUND THAT WAS DECREASING IN SIZE. ON (B)(6) 2007 THE PATIENT WAS ADMITTED TO HOSPITAL WITH RECURRENT VOMITING, FEVER, SEVERE HYPOKALEMIC, DIARRHEA, ABDOMINAL CRAMPS, AND WOUND INFECTION. LABS REVEALED LOW POTASSIUM AND ELEVATED LIVER FUNCTION. THE PATIENT UNDERWENT AN ABDOMEN OBSTRUCTIVE SERIES WITH PA CHEST WHICH REVEALED NO ACUTE PULMONARY DISEASE AND NO OBSTRUCTION. THE PATIENT WAS STARTED ON POTASSIUM SUPPLEMENTS AS WELL AS A POTASSIUM BOLUS. ON (B)(6) 2007 THE PATIENT PRESENTED WITH VOMITING, ABDOMINAL PAIN, NAUSEA AND ELEVATED LIVER FUNCTION STUDIES. THE PATIENT UNDERWENT AN ABDOMINAL ULTRASOUND WHICH SHOWED NO EVIDENCE OF GROSS INTRAHEPATIC OR EXTRA-HEPATIC DUCT DILATION. THE BILE DUCT WAS PROMINENT AT 7.6MM. THE PATIENT UNDERWENT LABS WHICH WERE POSITIVE FOR C.DIFF TOXIN. ON (B)(6) 2007 THE PATIENT UNDERWENT LABS WHICH REVEALED HIGH GLUCOSE, CHLORIDE, ALK PHO, AST, ALT, RDW AND LOW CREATININE, PROT TOTAL, ALBUMIN, A/G RATE, RBC, HGB, HCT, MCV, AND MCHC. THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE PATIENT WAS SENT HOME ON REGLAN, COMPAZINE, ACIPHEX, AND CIPRO. ON (B)(6) 2007 THE PATIENT PRESENTED WITH IMPROVING APPETITE AND AN IMPROVING WOUND SITE. ON (B)(6) 2007 THE PATIENT PRESENTED WITH CONTINUING BACK DISCOMFORT AND ABDOMINAL PAIN AND UNDERWENT A CT OF THE ABDOMEN AND PELVIS WHICH DEMONSTRATED RELATIVE BOWEL WALL THICKENING INVOLVING THE SIGMOID COLON WITH MILD INDURATION OF THE PERIRECTAL FASCIA WHICH MAY HAVE BEEN SECONDARY TO REMOTE DIVERTICULAR DISEASE OR MAY HAVE BEEN RELATED TO POSSIBLE RADIATION THERAPY CHANGES. THERE WAS MILD PROMINENCE OF THE COMMON BILE DUCT IN THE PANCREATIC HEAD. THE PATIENT ALSO PRESENTED WITH A HEADACHE AND UNDERWENT A BRAIN CT WHICH SHOWED NO AREAS OF ABNORMAL INCREASED OR DECREASED DENSITY, NO INTRA OR EXTRA-CEREBRAL BLEED, MIDLINE SHIFT, OR MASS EFFECT. THE PATIENT WAS SCHEDULED FOR AN EVALUATION FOR DIFFICULTY SPEAKING. ON (B)(6) 2007 THE PATIENT PRESENTED WITH CONTINUING PAIN IN THE BACK, PER THE ENCOUNTER NOTES THE PATIENT HAD SEEN ANOTHER DOCTOR FOR AN EVALUATION OF THEIR THROAT FOR DIFFICULTY SPEAKING AND THEY WERE NOW UNDERGOING SPEECH THERAPY. X-RAYS REVEALED ADEQUATE PROGRESSION OF THE FUSION. ON (B)(6) 2007 THE PATIENT PRESENTED WITH PAIN AND UNDERWENT LUMBAR SPINE X-RAYS WHICH SHOWED POST-SURGICAL CHANGES. THERE WAS ATHEROSCLEROSIS, SOME MILD SPURRING AT SEVERAL LEVELS SUGGESTING DEGENERATIVE DISC DISEASE, MILD IRREGULARITY OF THE ANTERIOR-SUPERIOR ENDPLATE OF L4, AND THE RIGHT SCREW EXTENDED MORE LATERALLY THAN THE LEFT S1 SCREW. ON (B)(6) 2007 THE PATENT UNDERWENT LABS WHICH REPORTED LOW HEMATOCRIT, CREATININE, ALBUMIN AND HGB AND A HIGH MPV AND SGOT. THE PATIENT PRESENTED WITH A RAW BLEEDING WOUND AT THE LUMBAR SITE, ON (B)(6) 2007 THE PATIENT WAS ADMITTED TO HOSPITAL WITH INTRA-ABDOMINAL PAIN AND DIARRHEA WITH TENDERNESS IN LEFT AND RIGHT LOWER QUADRANT OF THE ABDOMEN. ABDOMINAL X-RAYS WITH PA CHEST WERE TAKEN WHICH SHOWED NO ACUTE DISEASE OF THE CHEST AND NON-OBSTRUCTIVE BOWEL GAS PATTERN. A CT SCAN REVEALED EVIDENCE OF COLITIS, SUGGESTION OF A MILD ILEUS, COLONIC WALL THICKENING, AND ADRENAL NODULES. THE PATIENT WAS DIAGNOSED WITH C. DIFF. COLITIS. FINAL DIAGNOSIS: COLITIS ASSOCIATED WITH LEUKOCYTOSIS AND HYPOKALEMIA. THE PATIENT ALSO PRESENTED WITH NECK PAIN AND UNDERWENT CERVICAL SPINE X-RAYS WHICH WERE UNREMARKABLE. ON (B)(6) 2007 THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2014 THE PATIENT PRESENTED WITH IMPROVING LUMBAR AND SACRAL WOUND SITES. ON (B)(6) 2007 THE PATIENT PRESENTED WITH INTERMITTENT BACK DISCOMFORT. THE PATIENT REPORTED GOING TO THE HOSPITAL SEVERAL WEEKS PRIOR FOR LOW POTASSIUM AND A C. DIFF COLITIS INFECTION. PER THE ENCOUNTER NOTES THE NEUROLOGIC EXAM WAS WITHOUT CHANGE. LUMBAR SPINE X-RAYS WERE TAKEN WHICH SHOWED STATUS POST LAMINECTOMY AND FUSION AT L5-S1 WITH AN EXPECTED POST-OPERATIVE APPEARANCE AND INSTRUMENTATION INTACT. SOLID BONY FUSION WAS NOT YET EVIDENT. ON (B)(6) 2007 THE PATIENT PRESENTED CONSTANT BACK PAIN AND LOWER EXTREMITY WEAKNESS WITH NUMBNESS AND TINGLING IN THE SHIN. PER THE ENCOUNTER NOTES IT REPORTED THAT THE PATIENT HAD BEEN ALLERGIC TO THE STAPLES USED IN A PREVIOUS SURGERY AND THEY HAD TO BE ¿CUT BACK OPEN TO GET THAT OUT BUT HER INFECTIONS ARE CLEARED UP NOW¿. THE PATIENT REPORTED TROUBLE SPEAKING SINCE THE SURGERY SECONDARY TO VOMITING AND VOCAL CORD BEING SWOLLEN; LOSS OF WEIGHT (100LBS); AND DIFFICULTY SLEEPING. THE PATIENT ALSO STATED THEY THE ULTRAM MEDICATION WAS NOT WORKING WELL. THE PATIENT WAS ON DISABILITY. ON (B)(6) 2007 THE PATIENT PRESENTED WITH GENERALIZED WEAKNESS AND DIARRHEA (ONSET 4 DAYS PRIOR). ON (B)(6) 2007 THE PATIENT PRESENTED WITH IMPROVING PAIN. PER THE ENCOUNTER NOTES, X-RAYS REVEALED ADEQUATE PROGRESSION OF THE FUSION. RADIOGRAPHIC IMPRESSION: GROSSLY STABLE CHANGES FROM LUMBAR FUSION L5-S1. MILD DEGENERATIVE CHANGES PERSISTED. ON (B)(6) 2008 THE PATIENT PRESENTED WITH OCCASIONAL BACK PAIN. X-RAYS REVEALED ADEQUATE PROGRESSION OF THE FUSION. IN A (B)(6) 2008 LETTER, THE DOCTOR STATES THAT THE PATIENT HAD BEEN ON MULTIPLE MEDICATIONS, INCLUDING ANTIBIOTICS AND CHEMOTHERAPY OVER THE PAST THREE YEARS AND THAT IT WAS POSSIBLE THE MEDICATIONS INTERFERED WITH THE HEALTH OF THE PATIENTS TEETH. ON (B)(6) 2008 THE PATIENT UNDERWENT LUMBAR SPINE X-RAYS WHICH SHOWED ANTERIOR AND POSTERIOR LUMBAR SPINAL FUSION L5-S1 AND MILD DEXTROCURVATURE OF THE MID LUMBAR SPINE (POSSIBLE DUE TO POSITIONING). THERE WERE ALSO ATHEROSCLEROTIC VASCULAR CALCIFICATIONS NOTED IN THE ABDOMINAL AORTA. ON (B)(6) 2011 THE PATIENT PRESENTED WITH SEVERE, PIERCING, SHARP BACK PAIN THAT RADIATED DOWN THE BACK OF THE LEFT LEG. THE PATIENT REPORTED IT TINGLED A LOT. THE PATIENT REPORTED THAT THE PAIN WOKE THEM UP AT NIGHT AND WAS WORSE WITH MOVEMENT. MEDICATIONS: OXYCODONE, VITAMIN E, SYNTHOID, TOPAMAX, AND, METHOCARBAMOL. THE PATIENT ALSO REPORTED STARTING HYPERBOLIC TREATMENTS FOR THYROID CANCER TWO WEEKS PRIOR. A REVIEW OF X-RAYS OF THE LUMBAR SPINE REVEALED ADEQUATE PROGRESSION OF THE FUSION WITHOUT EVIDENCE OF HARDWARE FAILURE OR NONUNION. ON (B)(6) 2011 THE PATIENT PRESENTED WITH PAIN. THE PATIENT REPORTED THAT THEIR SYMPTOMS HAD WORSENED SINCE UNDERGOING HYPERBARIC TREATMENTS 3 WEEKS PRIOR, SECONDARY TO A REACTION FROM RADIATION. ON (B)(6) 2011 THE PATIENT PRESENTED WITH LOWER BACK DISCOMFORT. ON (B)(6) 2011 THE PATIENT UNDERWENT LABS WHICH REVEALED A HIGH WHITE COUNT. ON (B)(6) 2011 THE PATIENT PRESENTED WITH LOW BACK PAIN AND BILATERAL LEG PAIN, NUMBNESS AND VARIABLE WEAKNESS. THE PATIENT UNDERWENT A LUMBAR SPINE MRI W AND W/OUT CONTRAST, WHICH DEMONSTRATED STRAIGHTENING OF THE USUAL LUMBAR LORDOSIS AND MILD UPPER LUMBAR LEVOSCOLIOSIS; EPIDURAL FIBROSIS; SEVERE L4-L5 CENTRAL SPINAL CANAL STENOSIS; MINIMAL LEFT L3-4 AND MILD MODERATE BILATERAL L4-L5 FORAMINAL STENOSIS; NONSPECIFIC SERPENTINE HYPOINTENSE SIGNAL WITHIN THE LATERAL SACRAL ALA. SACRAL INSUFFICIENCY FRACTURE NOT EXCLUDED; BENIGN BILATERAL ADRENAL ADHESIONS; AND DIFFUSELY HETEROGENEOUS MARROW SPINAL SIGNAL POSSIBLY REFLECTING OSTEOPOROSIS. ON (B)(6) 2011 THE PATIENT PRESENTED WITH LOWER BACK AND BILATERAL BUTTOCKS PAIN. A MRI WAS REVIEWED WITH THE PATIENT WHICH SHOWED SEVERE STENOSIS AT THE L4-L5 LEVEL. IT WAS STATED IN THE ENCOUNTER NOTES THAT THE PATIENT WAS NOT A GOOD CANDIDATE FOR SURGERY AS SHE WAS UNDERGOING HYPERBARIC TREATMENTS. ON (B)(6) 2011 THE PATIENT REPORTED WORSENING LOWER BACK PAIN WITH NUMBNESS AND TINGLING IN HER LEG WHEN STANDING OR WALKING AND WHICH LIMITED ACTIVITIES. THE PATIENT REPORTED HAVING MORE SEIZURES AND HAD BEEN STARTED LEVETIRACETAM. IN THE EVENT NOTES IT STATED THE PATIENT ¿WAS NOT UNDERGOING THE HYPERBARIC TREATMENTS BECAUSE OF HER SEIZURE DISORDER.¿ SURGERY WAS DISCUSSED AND TENTATIVELY PLANNED. ON (B)(6) 2012 IN A NOTE CONCERNING AN UPCOMING SPINAL SURGERY, THE DOCTOR NOTED THAT ANTICONVULSANTS WOULD NEED TO BE CONTINUED VIA IV DURING RECOVERY. ON (B)(6) 2012 THE PATIENT PRESENT FOR A PRE-OP EKG WHICH WAS NORMAL. ON (B)(6) 2012 THE PATIENT UNDERWENT LABS WHICH REVEALED HIGH SODIUM, GLOBULIN AND A LOW A/G RATIO. ON (B)(6) 2012 THE PATIENT COMPLAINED OF WORSENING PAIN IN BACK AND NUMBNESS, PAIN AND TINGLING IN LEGS. THE PATIENT PRESENTED WITH THE DIAGNOSIS OF LUMBAR SPINAL STENOSIS AT L4-L5 AND L5-S1 AND UNDERWENT SURGERY WHICH CONSISTED OF A HARDWARE REVISION AT L5-S1; DECOMPRESSION LAMINECTOMY; DISCECTOMY; POSTERIOR LUMBAR INTERBODY FUSION USING WITH INTERBODY CAGE; BMP CONTAINING SPONGES ; LOCAL AUTO GRAFT ; PEDICLE SCREW STABILIZATION TO L4 TO L5 TO S1 AND PEDICLE SCREWS PLACED AT L4. PER THE OPERATIVE REPORT AN ¿¿INTERBODY CAGE OF SIZE 10 MM WERE THEN PACKED WITH BMP CONTAINING SPONGES AND LOCAL AUTOGRAFT WAS THEN PLACED INTO THE DISK SPACE. THERE APPEARED TO BE A TIGHT FIT. THE MIDAS REX WAS THEN USED TO FASHION AND INCISE THE PEDICLES AT L4 BILATERALLY. EACH PEDICLE WAS CANNULATED AND TAPPED AND PEDICLE SCREWS WERE PLACED. EACH PEDICLE SCREW WAS TESTED USING EVOKED EMGS. THERE WAS NO EVIDENCE OF PEDICLE SCREW BREAKOUT OR NERVE IRRITATION. PEDICLE SCREWS WERE THEN CONNECTED WITH PEDICLE SCREWS AT L5-S1 USING TITANIUM RODS. X-RAY WAS THEN OBTAINED, WHICH REVEALED PROPER PLACEMENT OF THE PEDICLE SCREWS AND THE INTERBODY CAGE AT L4-L5. WOUND WAS IRRIGATED WITH 3 L OF BACITRACIN CONTAINING SOLUTION. THE MIDAS REX WAS USED TO DECORTICATE THE TRANSVERSE PROCESS OF L4-L5. THE CROSSLINK CONNECTOR WAS PLACED. BMP CONTAINING SPONGE AND LOCAL AUTOGRAFTS WERE PLACED ON POSTEROLATERAL GUTTER¿¿ IT SHOULD BE NOTED THAT DENSE SCAR TISSUE WAS ENCOUNTERED IN THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. ON DAY THREE POST OP THE PATIENT REPORTED HEADACHE. ON (B)(6) 2012 THE PATIENT PRESENTED WITH HEADACHE AND INCREASED DRAINAGE FROM THE HEMOVAC. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF A WOUND EXPLORATION FOR A POSSIBLE SPINAL FLUID LEAK. NO CSF WAS IDENTIFIED AT THE TIME OF THE SURGERY HOWEVER DURA WAS COVERED WITH DURASEAL AND CSF LEAK PROGRESSIONS WERE CONTINUED. NO PATIENT COMPLICATIONS WERE NOTED. THE PATIENT REMAINED AT BED REST UNTIL (B)(6) 2012. ON (B)(6) 2012 THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2012 THE PATIENT PRESENTED WITH SOME WOUND DRAINAGE. THE PATIENT WAS TO CONTINUE ON LEVAQUIN AND PERCOCET. ON (B)(6) 2012 THE PATIENT PRESENTED WITH SOME WOUND DRAINAGE AND GRANULATION TISSUE IN THE MID PORTION OF THE WOUND. THE PATIENT WAS TO CONTINUE ON LEVAQUIN. ON (B)(6) 2012 THE PATIENT PRESENTED WITH CONTINUED WOUND DRAINAGE AND GRANULATION TISSUE. ON (B)(6) 2012 THE PATIENT PRESENTED WITH SOME WOUND DRAINAGE AND A FAIR AMOUNT OF GRANULATION TISSUE IN THE MID PORTION OF THE WOUND. THE PATIENT WAS GIVEN A PRESCRIPTION FOR PERCOCET AND LEVAQUIN. THE PATIENT UNDERWENT LABS REVEALING HIGH SEDIMENTATION RATES, RDW, AND PLATELETS AND LOW RBC, HEMOGLOBIN, AND HEMATOCRIT. ON (B)(6) 2012 THE PATIENT PRESENTED WITH IMPROVED WOUND DRAINAGE WITH SLIGHT GRANULATION TISSUE. PER THE ENCOUNTER NOTES X-RAYS REVEALED ADEQUATE PROGRESSION OF THE FUSION. THE PATIENT WAS TO CONTINUE ON LEVAQUIN. ON (B)(6) 2012 THE PATIENT PRESENTED WITH SPINAL STENOSIS AND UNDERWENT LUMBAR SPINE X-RAYS WHICH DEMONSTRATED MORE INSTRUMENTATION SINCE AN (B)(6) 2008 XRAY AND MILD SPONDYLOLISTHESIS AT L4-5. ON (B)(6) 2012 THE PATIENT PRESENTED WITH PAIN IN LOWER BACK INTO THE LEFT HIP AND SOMEWHAT DOWN THE LEG. THE PATIENT REPORTED THE PAIN HAD WORSENED OVER THE LAST MONTH. PER THE ENCOUNTER NOTES X-RAYS REVEALED ADEQUATE PROGRESSION OF FUSION WITHOUT EVIDENCE OF HARDWARE FAILURE. MEDICATIONS: SYNTHROID, OXYCODONE-ACETAMINOPHEN, METHOCARBAMOL, AND TOPAMAX. ON (B)(6) 2012 THE PATIENT PRESENTED WITH BACK PAIN AND UNDERWENT LUMBAR SPINE X-RAYS WHICH DEMONSTRATED NO SOLID BONY FUSION, ENDPLATES ABOUT THE OPERATED L4-5 DISC SPACE WERE INDISTINCT WITH AREAS OF LUCENCY SUGGESTING INFECTION AND SOME RADIOLUCENCY ABOUT THE SCREWS AT L5-S1. ON (B)(6) 2012 THE PATIENT PRESENTED WITH LUMBAR PAIN AND LEFT RADICULOPATHY. IT ALSO RECOUNTED THAT THE PATIENT HAD UNDERGONE FOUR SURGERIES. THE PATIENT UNDERWENT A LUMBAR SPINE MRI WHICH DEMONSTRATED FUSION OF L4, 5 AND S1; A L4-5 SMALL BULGE OF THE GRAFT; OSTEOPHYTE FROM THE HYPERTROPHIED FACET CAUSING MODERATE LEFT FORAMINAL NARROWING; L5-S1 DISC PROJECTING BROADLY POSTERIORLY WITH AN ANNULAR TEAR AND MILD NEUROFORAMINAL NARROWING L5-S1. IN THE POSTERIOR ELEMENTS OF L5, SEPTATED FLUID COLLECTION MEASURING 2.5X3.1X2.2 CM WAS PRESENT WITHOUT APPRECIABLE MASS. EDEMA WAS SEEN IN THE SUBCUTANEOUS TISSUES ¿ ALL CONSISTENT WITH RECENT SURGERY. ON (B)(6) 2012 THE PATIENT UNDERWENT LABS WHICH REPORTED LOW HEMOGLOBIN, HEMATOCRIT, MCV, AND MCH AND HIGH SEDIMENTATION RATE, RDW AND PLATELETS. ON (B)(6) 2012 THE PATIENT PRESENTED WITH LEFT BUTTOCK, LEFT GROIN, LEFT THIGH PAIN. THE PATIENT REPORTED THAT THIS COMES ON WITH STANDING OR WALKING LONGER THAN 20 MINUTES. THE PATIENT ALSO REPORTED LEFT GROIN AND LEFT THIGH PAIN AT THE END OF THE DAY AS WELL AS PAIN WITH ROM OF LEFT LEG AND THIGH. REVIEW OF A MRI REVEALED POST OP CHANGES AT L4, L5, AND S1. ¿OSTEOPHYTE FROM HYPERTROPHIED FACET CASES MODERATE LEFT NEUROFORAMINAL NARROWING¿IN THE POSTERIOR ELEMENTS OF L5, SEPARATED FLUID COLLECTION MEASURING 2.5X3.1X2CM IS PRESENT WITHOUT APPRECIABLE MASS EFFECT. EDEMA IS SEEN IN THE SUBCUTANEOUS TISSUES ALL CONSISTENT WITH RECENT SURGERY.¿ ON (B)(6) 2012 THE PATIENT PRESENTED WITH LOWER BACK, LEFT BUTTOCK, LEFT GROIN, AND LEFT THIGH PAIN. THE PATIENT COMPLAINED THE SYMPTOMS WERE WORSENING. PER THE ENCOUNTER NOTES X-RAYS REVEALED ADEQUATE HEALING WITHOUT EVIDENCE OF HARDWARE FAILURE OR LOOSENING. THE PATIENT UNDERWENT LABS WHICH REVEALED A HIGH SEDIMENTATION RATE AND RDW AND LOW HEMOGLOBIN AND MCH. ON (B)(6) 2012 THE PATIENT PRESENTED POST LAMINECTOMY FOR LUMBAR SPINE RADIOGRAPHS WHICH SHOWED INCREASED OBSTRUCTION OF ENDPLATES ALONG THE L4-L5 DISC SPACE SUSPICIOUS INFECTION/DISCITIS AND ONGOING LUCENCY ALONG THE RIGHT PEDICLE SCREWS OF L5 AND S1. ON (B)(6) 2012 THE PATIENT PRESENTED WITH BACK PAIN AND UNDERWENT LUMBAR SPINE X-RAYS WHICH WERE SUSPICIOUS FOR DISCITIS/VERTEBRAL BODY OSTEOMYELITIS AT L4-L5. ON (B)(6) 2012 THE PATIENT PRESENTED WITH PAIN IN LOWER BACK AND INTO THE LEFT LEG. X-RAYS REVEALED ¿AGGRESSIVE HEALING AT THE L4-L5 LEVEL.¿ IN A (B)(6) 2012 LETTER, THE DOCTOR RECOMMENDED THE PATIENT SEEK PAIN MANAGEMENT SERVICES FOR HER CHRONIC PAIN MEDICATION.
ON (B)(6) 2012:THE PATIENT UNDERWENT AP AND LATERAL X-RAY OF LUMBAR SPINE DUE TO SPINAL STENOSIS POST OP. IMPRESSION: SINCE 2008, THERE HAS BEEN EXTENSION OF THE INSTRUMENTATION AND FUSION PROCEDURE TO INCLUDE L4 THROUGH S1. ON (B)(6) 2012: THE PATIENT UNDERWENT AP/LATERAL X-RAYS OF LUMBAR SPINEDUE TO LOW BACK PAIN. ON (B)(6) 2012: THE PATIENT PRESENTED FOR FOLLOW UP DUE TO CLEAR DRAINAGE FROM HER WOUND, FLU, CHILLS. ON (B)(6) 2012:THE PATIENT UNDERWENT AP/LATERAL X-RAYS OF LUMBAR SPINE DUE TO LOW BACK PAIN. ON (B)(6) 2012: THE PATIENT UNDERWENT AP/LATERAL X-RAYS OF LUMBAR SPINE DUE TO LUMBAGO. ON (B)(6) 2012:THE PATIENT PRESENTED FOR FOLLOW UP DUE TO INTERMITTENT JERKING OF HER LEFT LEG. SHE IS PROGRESSING SATISFACTORILY. ON (B)(6) 2012:THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE DUE TO BACK PAIN. IMPRESSION: ENDPLATES ABOUT THE OPERATED L4-L5 DISC SPACE ARE INDISTINCT WITH AREAS OF RADIOLUCENCY SUGGESTING INFECTION. CLINICAL CORRELATION RECOMMENDED. RECOMMEND EITHER CT OR MRI; POSTSURGICAL CHANGES WITH LAMINECTOMY AND FUSION PROCEDURE WITH POSTERIOR INSTRUMENTATION AND INTERBODY MATERIAL L4-L5 AND LS-SI WITH SOME RADIOLUCENCY ABOUT THE SCREWS AS DESCRIBED FINDINGS OTHERWISE ARE UNCHANGED. ON (B)(6) 2012: THE PATIENT PRESENTED FOR FOLLOW UP. SHE REPORTS SOME DISCOMFORT WITH RANGE OF MOTION OF HER LEFT HIP JOINT. IT DOES NOT APPEAR THAT SHE HAS A LUMBAR WOUND INFECTION EITHER BY THE MRI OR HER PHYSICAL EXAMINATION. THE PAIN IS LOCALIZED TO HER LEFT HIP JOINT AND LEFT GROIN WHICH IS SUGGESTIVE OF LEFT HIP PATHOLOGY.
ON (B)(6) 2012:THE PATIENT UNDERWENT AP AND LATERAL X-RAY OF LUMBAR SPINE DUE TO SPINAL STENOSIS POST OP. IMPRESSION: SINCE 2008, THERE HAS BEEN EXTENSION OF THE INSTRUMENTATION AND FUSION PROCEDURE TO INCLUDE L4 THROUGH S1. ON (B)(6) 2012: THE PATIENT UNDERWENT AP/LATERAL X-RAYS OF LUMBAR SPINEDUE TO LOW BACK PAIN. ON (B)(6) 2012: THE PATIENT PRESENTED FOR FOLLOW UP DUE TO CLEAR DRAINAGE FROM HER WOUND, FLU, CHILLS. ON (B)(6) 2012:THE PATIENT UNDERWENT AP/LATERAL X-RAYS OF LUMBAR SPINE DUE TO LOW BACK PAIN. ON (B)(6) 2012: THE PATIENT UNDERWENT AP/LATERAL X-RAYS OF LUMBAR SPINE DUE TO LUMBAGO. ON (B)(6) 2012:THE PATIENT PRESENTED FOR FOLLOW UP DUE TO INTERMITTENT JERKING OF HER LEFT LEG. SHE IS PROGRESSING SATISFACTORILY. ON (B)(6) 2012:THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE DUE TO BACK PAIN. IMPRESSION: ENDPLATES ABOUT THE OPERATED L4-L5 DISC SPACE ARE INDISTINCT WITH AREAS OF RADIOLUCENCY SUGGESTING INFECTION. CLINICAL CORRELATION RECOMMENDED. RECOMMEND EITHER CT OR MRI; POSTSURGICAL CHANGES WITH LAMINECTOMY AND FUSION PROCEDURE WITH POSTERIOR INSTRUMENTATION AND INTERBODY MATERIAL L4-L5 AND LS-SI WITH SOME RADIOLUCENCY ABOUT THE SCREWS AS DESCRIBED FINDINGS OTHERWISE ARE UNCHANGED. ON (B)(6) 2012: THE PATIENT PRESENTED FOR FOLLOW UP. SHE REPORTS SOME DISCOMFORT WITH RANGE OF MOTION OF HER LEFT HIP JOINT. IT DOES NOT APPEAR THAT SHE HAS A LUMBAR WOUND INFECTION EITHER BY THE MRI OR HER PHYSICAL EXAMINATION. THE PAIN IS LOCALIZED TO HER LEFT HIP JOINT AND LEFT GROIN WHICH IS SUGGESTIVE OF LEFT HIP PATHOLOGY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458584 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M111101AAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |