FDA Adverse Event Injury Summary report: N

INFUSE BONE GRAFT

MDR report key: 3922816 · Received July 9, 2014

Report

Report Number
1030489-2014-03167
Event Type
Injury
Date Received
July 9, 2014
Report Date
June 3, 2015
Manufacturer
MEDTRONIC SOFAMOR DANEK USA, INC
Product Code
NEK
PMA / PMN Number
P000058
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

(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.

Additional Manufacturer Narrative · 1

PER THE IMAGE REVIEW, THE FINDINGS ARE AS FOLLOWS: (B)(6) 2011 LUMBAR X-RAYS AP AND LATERAL COPIES ARE PROVIDED OF A LUMBAR SPINE. THE REPRODUCTION OF THE FILMS IS POOR. NEVERTHELESS DEGENERATION OF THE L5 MOTION SEGMENT IS SEEN WITH SOME HYPERLORDOSIS OF THE LUMBAR SPINE. NO APPARENT SPONDYLOLISTHESIS CAN BE SEEN. AP VIEW INCLUDES THE ENTIRE PELVIS. THERE IS APPARENT SACRALIZATION OF L5 ON THE LEFT. LUMBAR SPINE IS STRAIGHT. SACROILIAC JOINTS, HIPS AND PUBIS ALL APPEAR NORMAL. THERE APPEARS TO BE NO IMPLANTS WITHIN THIS SPINE AND NO SIGNS OF SIGNIFICANT LAMINA RESECTION. ON (B)(6) 2012 FLUOROSCOPIC LUMBAR AP SINGLE VIEW OF LUMBAR SPINE CENTERED ABOVE SACRALIZED LEVEL AT APPROXIMATELY L4. THERE ARE SIX 25-GAUGE NEEDLES IN POSITION CENTERED ON THE FACET JOINTS OF L2/3, L3/4 AND L4/5. THESE NEEDLES ARE NOT WITHIN THE FACET JOINTS BUT APPEAR TO BE SET UP FOR MEDIAL BRANCH BLOCKS WITH THE EXCEPTION OF THE MOST CEPHALAD NEEDLE ON THE LEFT. THIS APPEARS TO BE WITHIN THE FACET JOINT AT THIS LEVEL. THERE APPEARS TO BE NO IMPLANTS WITHIN THIS SPINE AND NO SIGNS OF SIGNIFICANT LAMINA RESECTION.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION.

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4). REVIEW OF RADIOGRAPHIC IMAGES FOUND AS FOLLOWS: 2/17/2012 INTEROPERATIVE AP AND LATERAL LUMBAR FILMS SHOWING 25 GAUGE NEEDLES WITHIN FACETS AT L3/4, L4/5 AND L5/S1. (B)(6) 2012 INTEROPERATIVE LATERAL LUMBAR X-RAY WITH CEREBELLAR RETRACTORS IN PLACE AND KOCHER CLAMP ON L4 SPINOUS PROCESS. (B)(6) 2013 LUMBAR X-RAYS AP AND LATERAL VIEWS SHOW ANOMALY OF L5 WITH SPONDYLOLISTHESIS AND POSTERIOR ELEMENT DEFORMITY. NO IMPLANTS NOTED ON THIS STUDY. (B)(6) 2013 AP LUMBAR X-RAY NO INTERVAL CHANGE FROM (B)(6). (B)(6) 2013 LUMBAR SPINE SERIES 3 VIEWS SHOWING NO CHANGES FROM PREVIOUS STUDIES (B)(6) 2013 LUMBAR SERIES 3 VIEWS SHOWING NO CHANGES FROM PREVIOUS STUDIES.

Additional Manufacturer Narrative · 1

REVIEW OF RADIOGRAPHIC IMAGES FOUND AS FOLLOWS: (B)(6) 2011 LUMBAR MRI. SAGITTAL AND AXIAL T1 AND T2 IMAGES ARE PROVIDED. GOOD DISC SIGNAL IS SEEN AT ALL LUMBAR LEVELS. NO CLEAR STENOSIS IS SEEN. ALL LEVELS APPEAR TO HAVE NO STENOSIS AND REASONABLY NORMAL ANATOMY. NO EVIDENCE OF HNP OR STENOSIS AT ANY LEVEL. OVERALL BONY RELATIONSHIPS ARE WELL MAINTAINED THROUGHOUT THE LUMBAR SPINE. (B)(6) 2011 LUMBAR CT AXIAL VIEWS SHOW PREVIOUS POSTERIOR FUSION AT L5/S1. NO STENOSIS OR HETEROTOPIC BONE IS SEEN ABOUT THE NEURAL ELEMENTS. THE DURAL SAC IS NARROWED TO THE UPPER LIMITS OF NORMAL IN MIDLINE AT L4. SAGITTAL RECONSTRUCTIONS DO NO SHOW SOLID ARTHRODESIS BETWEEN L5 AND S1. LUMBAR AP AND LATERAL X-RAYS 6 VIEWS NO INSTRUMENTATION IS SEEN. SIGNIFICANT BONE IS SEEN POSTEROLATERALLY BETWEEN L5 AND S1. DYNAMIC VIEWS SHOW MOVEMENT FROM L4 CEPHALAD, BUT CANNON VERIFY EITHER WAY MOVEMENT AT L5 DUE TO POOR TECHNIQUE. (B)(6) 2011 TECHNETIUM BONE SCAN LUMBAR SCAN SHOW SLIGHT INCREASED UPTAKE IN THE LEFT KIDNEY AND LEFT MID L4 BODY. SPINE OTHERWISE HAS NO ABNORMAL SIGNAL (B)(6) 2012 FLUOROSCOPIC AP OF LUMBAR SPINE WITH SIX NEEDLES PLACED NEAR THE FACET JOINTS AT L3/4, L4/5 AN L5/S1. ONLY TWO AP VIEWS ARE SHOWN WITHOUT LATERAL. NEEDLE TIPS ARE NOT WITHIN THE FACET JOINTS, YET THE LEFT L3 IS TOO MEDIAL FOR MEDIAL BRANCH INJECTION. THEY ARE AT THE LEVEL OF THE PEDICLE SO TRANSFORAMINAL INJECTIONS ARE NOT LIKELY. (B)(6) 2012 LUMBAR SERIES 4 VIEWS FLEXION, EXTENSION AND AP/LATERAL VIEWS ARE SHOWN. NO MOVEMENT IS SEEN AT L5 HOWEVER CLEAR MOVEMENT IS SEEN ACROSS L4 AND LEVELS PROXIMAL BETWEEN THE FLEXION AND EXTENSION VIEWS. AP SUGGESTS ABUNDANT POSTEROLATERAL BONE FROM L4 TO S1. (B)(6) 2012 INTRAOPERATIVE FLUOROSCOPY SINGLE LATERAL VIEW CENTERED UPON L4. WHEATLANDER RETRACTORS ARE PRESENT AND KOCHER CLAMP IS ON THE SPINOUS PROCESS OF L4 (B)(6) 2013 LUMBAR FILMS 2 VIEWS AP AND LATERAL LUMBAR FILMS SHOW NORMAL ALIGNMENT WITHOUT INSTRUMENTATION. THERE ARE SIGNS OF DEGENERATIVE DISC DISEASE GREATEST AT L5 WITH POSTERIOR FUSION BONE IN THE L4 TO S1 REGION. (B)(6) 2013 LUMBAR FILMS 2 VIEWS NORMAL ALIGNMENT WITHOUT INSTRUMENTATION. THERE ARE SIGNS OF DEGENERATIVE DISC DISEASE GREATEST AT L5 WITH POSTERIOR FUSION BONE IN THE L4 TO S1 REGION. (B)(6) 2013 LUMBAR CT SOLID POSTERIOR FUSION IS VERIFIED AT L5/S1 IN THIS STUDY. POSTERIOR FUSION BONE IS SEEN AS PROXIMAL AS L3 HOWEVER SOLID FUSION IS NOT SUSPECTED ABOVE L5. NO STENOSIS IS SUSPECTED ALTHOUGH DURAL SAC IS AT THE LOWER LIMITS OF NORMAL AT L4. (B)(6) 2013 RETROGRADE URETHROGRAM AND PYLOGRAM LEFT KIDNEY NO SPINAL PATHOLOGY IS CLEARLY DELINEATED (B)(6) 2013 RETROPERITONEAL ULTRASOUND (KIDNEY STONES) NO SPINAL PATHOLOGY CAN BE VERIFIED FROM THIS SCAN.

Additional Manufacturer Narrative · 1

IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT PRESENTED WITH THE CHIEF COMPLAINTS OF PAIN IN PENIS <(>&<)> TESTICLE, PAIN AFTER URINATION AND ALSO HAD RINGING IN LEFT EAR. HE DESCRIBED THE PAIN AS CONSTANTLY BURNING ABOUT 3 WEEKS AROUND PENIS. ASSESSMENT: DYSURIA. ON (B)(6) 2010 THE PATIENT PRESENTED FOR THE FOLLOW UP ON LAB RESULTS. HE REPORTEDLY INDICATED ITCHING OF URETHRA. ASSESSMENT: URETHRITIS; PROSTATITIS. URINALYSIS WAS NEGATIVE (B)(6) 2010 THE PATIENT PRESENTED WITH THE CHIEF COMPLAINT OF LEFT LOWER BACK PAIN X 2 WEEKS. THE PATIENT STATED THAT IT WAS PAINFUL AND BURNING WHILE URINATING. HE ALSO REPORTED FREQUENT URINATION. THERE WAS TENDERNESS ON THE LATERAL ROTATION OF LEFT THORACIC BACK T8-L1. URINALYSIS WAS NEGATIVE. ASSESSMENT: DYSURIA; LEFT THORACIC MUSCLE STRAIN.

Description of Event or Problem · 1

IT WAS REPORTED THAT RHBMP-2/ACS WAS USED IN THIS PATIENT. BETWEEN THE DATES OF (B)(6) 2010, THE PATIENT SOUGHT CARE FROM PHYSICIANS FOR DEBILITATING PAIN. REPORTEDLY, PHYSICIANS FAILED TO DIAGNOSE THE PATIENT'S RENAL CALCULUS, TREAT IT OR REFER TO SOMEONE WHO COULD TREAT IT. PHYSICIANS INSTEAD ALLEGEDLY SUBJECTED PATIENT TO "UNNECESSARY RADIATION, DRUGS, SURGERIES, AND OTHER MEDICAL PROCEDURES, NONE OF WHICH SOLVE HIS PROBLEM OR REMEDIED HIS PAIN." NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

Description of Event or Problem · 1

ON (B)(6) 2012: INTRAOPERATIVELY, X-RAY IMAGING AND FLUOROSCOPY WAS CARRIED OUT. 1ON (B)(6) 2012 THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL WITH THE FOLLOWING DIAGNOSES: PSEUDO ARTHROSIS OF L5-S1 AND; STATUS POST L5-S1 NON INSTRUMENTED FUSION WITH THE USE OF BMP. ON (B)(6) 2013: PATIENT UNDERWENT X-RAY OF LUMBAR SPINE STATUS POST DECOMPRESSION. IMPRESSION: SPONDYLOSIS. TRANSITIONAL ANATOMY WITH H YPERTROPHIC CHANGES ABOUT THE LUMBOSACRAL JUNCTION. THERE IS MATURING PARASPINOUS GRAFT MATERIAL. ON (B)(6) 2013 THE PATIENT PRESENTED WITH THE DIAGNOSES OF DISC DEGENERATIVE DISEASE AND LUMBAR STRAIN. HE DESCRIBED THE PAIN AS ACHING AND DULL. ON (B)(6) 2013: PATIENT UNDERWENT X-RAY OF LUMBAR SPINE STATUS POST LUMBAR FUSION. IMPRESSION: NO SIGNIFICANT CHANGE FROM PRIOR WITH MILD DEGENERATIVE DISC DISEASE IN THE LOWER LUMBAR SPINE. ON (B)(6) 2013: THE PATIENT WAS INITIALLY SEEN ON (B)(6) 2013 AND UNDERWENT THE FOLLOWING TREATMENTS: THERAPEUTIC EXERCISE; SOFT TISSUE MOBILIZATION, POSTURAL ED; STABILIZATION; HOME EXERCISE PROGRAM; D/C PLANNING, PATIENT EDUCATION; AND MANUAL THERAPY. HE STATED THAT THE PAIN WAS ALONG THE RIBS ON THE LEFT SIDE OF HIS BACK WITH RADIATION DOWN INTO THE LEFT HIP. HE WAS DISCHARGED FROM PHYSICAL THERAPY. ON (B)(6) 2013 THE PATIENT PRESENTED WITH BACK PAIN WITH RADICULITIS AND THE DIAGNOSIS OF SACROILIITIS AND UNDERWENT A LEFT S1 JOINT INJECTION. NO PATIENT COMPLICATIONS WERE NOTED. THE PROCEDURE WAS CARRIED OUT UNDER FLUOROSCOPIC GUIDANCE. ON (B)(6) 2013: PATIENT UNDERWENT FLUOROSCOPY. IMPRESSION: FLUOROSCOPY WAS PROVIDED. TOTAL FLUOROSCOPIC TIME UTILIZED WAS 16 SECONDS. NO DIAGNOSTIC REPORT WILL BE ISSUED BY RADIOLOGY. ON (B)(6) 2011: ACUPUNCTURE FOR LOWER BACK PAIN CHRONIC LOW BACK PAIN (B)(6) 2012: PER THE PATIENT'S LOG OF "BACK PAIN DOCTOR HISTORY", THE PATIENT PRESENTED FOR A CONSULTATION ON PAIN. CICLOFENAC SODIUM 75MG WAS PRESCRIBED. THE PATIENT HAD THE FOLLOWING DIAGNOSIS: L3-4 DEGENERATIVE DISC DISEASE (B)(6) 2013: THE PATIENT PRESENTED FOR AN OFFICE VISIT.

Description of Event or Problem · 1

PER THE MEDICAL RECORDS, IT WAS REPORTED THAT ON (B)(6) 2013: THE PATIENT PRESENTED WITH SYMPTOMS RELATED TO THE LEFT SACROILIAC JOINT. THE PATIENT REPORTED THE PAIN WAS WORSE SINCE RECEIVING A S1 JOINT INJECTION THE WEEK PRIOR. THE PATIENT WAS UTILIZING A CORSET WHICH HE FOUND HELPFUL. THE PATIENT ALSO STATED THEY WERE IN CONSTANT PAIN. THE PATIENT WAS EXQUISITELY TENDER OVER THE LEFT BUTTOCK AND LEFT S1 JOINT.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT REPORTEDLY UNDERWENT A LUMBAR SPINE CT. ON (B)(6) 2013 THE PATIENT PRESENTED WITH LOW BACK PAIN RADIATING TO THE LEFT BUTTOCK WITH A HISTORY OF EFFUSION. THE PATIENT UNDERWENT A LUMBAR SPINE CT WHICH DEMONSTRATED MULTILEVEL DISCOGENIC DISEASE OF THE LUMBAR SPINE, NOT SIGNIFICANTLY CHANGED FROM CT DATED (B)(6) 2011; L3-4: MILD CENTRAL STENOSIS AND MILD-TO-MODERATE LEFT GREATER THAN RIGHT NEUROFORAMINAL. NARROWING WAS UNCHANGED FROM PRIOR EXAM; LS-S1: STATUS POST INTERTRANSVERSE FUSION WITH SOLID BILATERAL POSTEROLATERAL FUSION MASSES IDENTIFIED WITHOUT CENTRAL STENOSIS. NO NEUROFORAMINAL NARROWING WAS IDENTIFIED. CHRONIC BILATERAL L5 PARS DEFECTS WERE REDEMONSTRATED; AND AN INTERVAL INCREASED SIZE OF A LEFT RENAL PELVIS CALCULUS MEASURING 1.5 CM WITH STABLE MINIMAL HYDROURETERONEPHROSIS. IT SHOULD BE NOTED THAT THERE WAS NO FRACTURE WITHIN THE SACRUM FROM THE S1 TO THE INFERIOR L5 LEVEL. NO OSSEOUS SACRAL NEUROFORAMINAL NARROWING WAS IDENTIFIED. VA CUUM DISC PHENOMENON OF THE BILATERAL SACROILIAC JOINTS WAS NOTED. ON (B)(6) 2013 THE PATIENT PRESENTED WITH LEFT HYDRONEPHROSIS SECONDARY TO A LEFT RENAL STONE. A CT SCAN HAD SHOWN A 1.5 CM LEFT RENAL PELVIC STONE BLOCKING THE KIDNEY. PER THE ENCOUNTER NOTES THE PATIENT HAD BEEN IN AND OUT OF THE ER WITH PAIN AND NOW PRESENTED FOR DEFINITIVE TREATMENT. ON (B)(6) 2013 THE PATIENT UNDERWENT AN ECG AND VARIOUS LABS INCLUDING BUT NOT LIMITED TO A CBC AND BMP. LABS REVEALED SLIGHTLY ELEVATED GLUCOSE, LEUCOCYTES, AND PROTEIN. THEECG WAS NORMAL. THE PATIENT UNDERWENT SURGERY THAT CONSISTED OF AN URETEROSCOPIC STONE REMOVAL WITH PLACEMENT OF A LEFT DOUBLE J-STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATHOLOGY OF THE STONE REVEALED KIDNEY CALCULI. ON (B)(6) 2013 THE PATIENT WAS DISCHARGED FROM HOSPITAL. (B)(6) 1984: THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL FUSION SURGERY. (B)(6) 2002: THE PATIENT UNDERWENT A CERVICAL DISCECTOMY. (B)(6) 2010: THE PATIENT PRESENTED WITH LOW BACK PAIN OVER THE LOWER LUMBAR SPINE. X-RAYS OF THE LUMBAR SPINE SHOWS LOSS OF LUMBAR LORDOSIS. ASSESSMENT: LOW BACK PAIN WITHOUT RADICULAR SYMPTOMS. (B)(6) 2011: THE PATIENT PRESENTED WITH PAIN IN THE LEFT SIDE OF HIS LOW BACK, TIGHTNESS, STIFFNESS, WEAKNESS, NUMBNESS, AND TINGLING. X-RAYS TAKEN DEMONSTRATE SOME DISC SPACE NARROWING AT L5-S1. DIAGNOSIS: LEFT SCIATICA. (B)(6) 2011: THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. FINDINGS: THERE IS SOLID BONY FUSION AT L4-5 AND L5-S1 WITH 2 MM DISC BULGE AT L3-4 AND MILD CENTRAL CANAL STENOSIS AT L3-4. THERE IS NO NERVE ROOT CANAL NARROWING OR CENTRAL CANAL STENOSIS IN THE FUSED AREA. THERE IS NERVE ROOT CANAL NARROWING DUE TO BROAD BASED DISC PROTRUSION AT FACET HYPERTROPHY AT THE L3-4 LEVEL. (B)(6) 2011: THE PATIENT UNDERWENT A LUMBAR EPIDURAL STEROID BLOCK UNDER FLUOROSCOPY WITH EPIDUROGRAPHY AT LEFT L5-S1. (B)(6) 2011: THE PATIENT PRESENTED WITH LUMBAR RADICULOPATHY AND DISC HERNIATION AS WELL AS POST LAMINECTOMY SYNDROME. THE PATIENT UNDERWENT A LUMBAR EPIDURAL STEROID BLOCK UNDER FLUOROSCOPY WITH EPIDUROGRAPHY AT L5-S1. (B)(6) 2011: THE PATIENT PRESENTED WITH PAIN RADIATING FROM HIS LOWER BACK INTO HIS LEFT LATERAL HIP AND SHIN. DIAGNOSES: STABLE L4 THROUGH S1 FUSION WITH L5-S1 DISC SPACE NARROWING; SEVERE PAIN WITH STANDING RADIATING INTO THE POSTEROLATERAL ASPECT OF THE LEFT HIP AND SHIN. (B)(6) 2011: THE PATIENT PRESENTED WITH PAIN RADIATING INTO HIS LEFT LATERAL HIP AND SHIN. EPIDURAL STEROID INJECTIONS PROVIDED NO RELIEF. THE PATIENT PROVIDED AN MRI FROM APRIL THAT DEMONSTRATED SOLID BONY FUSION AT L5-S1 WITH HEMILAMINECTOMY AT L4-5 AND MILD STENOSIS AT THE L3-4 LEVEL. DIAGNOSIS: MODERATE LEFT L5 SENSORY NERVE ROOT DYSFUNCTION WITHOUT DENERVATION. THE PATIENT UNDERWENT ELECTRODIAGNOSTICAND NERVE CONDUCTION STUDIES. IMPRESSION: MODERATE LEFT L5 SENSORY NERVE ROOT DYSFUNCTION, NOT SEEN ON THE RIGHT. NORMAL BILATERAL L3, L4, AND S1 RESPONSES. NORMAL LEFT PERONEAL AND POSTERIOR TIBIAL MOTOR FUNCTION AT THE ANKLE AND ACROSS THE FIBULAR HEAD. NO EVIDENCE OF PERIPHERAL NEUROPATHY. NO EMG EVIDENCE OF LEFT LUMBOSACRAL RADICULOPATHY WITH ACTIVE OR CHRONIC DENERVATION. ON (B)(6) 2011 THE PATIENT REPORTEDLY UNDERWENT A LUMBAR SPINE CT. IMPRESSION: CHRONIC BILATERAL L5 PARS DEFECT; PREVIOUS INNER TRANSVERSE SOLID BONY FUSION AT L5-S1; MULTILEVEL DEGENERATIVE CHANGES AT L3-4 WHERE THERE IS MILD CENTRAL SPINAL STENOSIS AND MILD - MODERATE BILATERAL NEUROFORAMINAL NARROWING. THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE WITH BENDING VIEWS. IMPRESSION: TRANSITIONAL LUMBAR ANATOMY WITH SACRALIZATION OF L5; MILD LUMBAR VERTEBRAL SPONDYLOSIS. (B)(6) 2011: THE PATIENT UNDERWENT BONE SCAN WITH SPECT IMAGING. CONCLUSION: EXCELLENT QUALITY NEGATIVE LUMBAR SPINE BONE SCAN AND BONE SPECT SCAN; NO ABNORMAL ACTIVITY IS SEEN WITHIN EITHER THE ANTERIOR COLUMN OR THE POSTERIOR COLUMN OF THE LUMBAR SPINE. (B)(6) 2011: THE PATIENT PRESENTED WITH LOW BACK PAIN AND UNDERWENT A LUMBAR DISKOGRAM. IMPRESSION: THERE IS NO REPRODUCTION OF THE PATIENT'S CLINICAL LOW BACK PAIN AT L3-4 AND L4-5; AT L3-4 THERE IS MODERATE DISK DEGENERATION, SMALL RIGHT LATERAL DISC BULGE; AT L4-5, THERE IS MILD DISK DEGENERATION AND THERE WAS APPARENT FIBROSIS WITHIN THE DISK NUCLEUS, THERE IS NO EVIDENCE OF DISC PROTRUSION. THE PATIENT ALSO UNDERWENT CT OF THE LUMBAR SPINE WITH CONTRAST. IMPRESSION: L2-3 MILD DIFFUSE DISC BULGE, MODERATELY LARGE LEFT FORAMINAL PROTRUSION; L3-4 MODERATE DISK DEGENERATION, SMALL CENTRAL TO RIGHT PARASAGITTAL POSTERIOR ANNULAR TEAR WITH VENTRAL EPIDURAL FLOW OF CONTRAST FROM L2 TO THE SACRUM, MILD FACET ARTHRITIS WITH MILD NARROWING OF THE LEFT NEURAL FORAMEN; L4-5 MILD DISC DEGENERATION, A SMALL PARTIAL THICKNESS ANNULAR TEAR IN THE RIGHT POSTERIOR PARASAGITTAL AREA, NO FULL THICKNESS ANNULAR TEAR IS IDENTIFIED. (B)(6) 2011: THE PATIENT PRESENTED WITH LOW BACK PAIN. DIAGNOSES: POST FUSION SYNDROME L5-S1; L4-5 FACET ARTHROPATHY. (B)(6) 2012: THE PATIENT PRESENTED WITH LUMBAR FACET ARTHROPATHY. THE PATIENT UNDERWENT A BILATERAL L3-4, L4-5, L5-S1 MEDIAL BRANCH BLOCK. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6) 2012: THE PATIENT PRESENTED WITH BILATERAL LUMBAR FACET ARTHROPATHY. THE PATIENT UNDERWENT A BILATERAL L3-4, L4-5, AND L5-S1 RADIOFREQUENCY ABLATION. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6) 2012: THE PATIENT CALLED IN STATING HE WAS HAVING REALLY BAD PAIN AND MUSCLE SPASMS. (B)(6) 2012: THE PATIENT PRESENTED FOR FOLLOW UP STATING HIS PAIN HAS INCREASED AND FEELS DIFFERENT. ASSESSMENT: LUMBAR FACET ARTHROPATHY. (B)(6) 2012: THE PATIENT PRESENTED WITH PINPOINT LOCATION OF LOW BACK PAIN WITH NON-RADIATING QUALITIES. ASSESSMENT: MYOFASCIAL PAIN; LUMBAR FACET ARTHROPATHY. (B)(6) 2012: THE PATIENT PRESENTED WITH LUMBAR FACET ARTHROPATHY. THE PATIENT UNDERWENT A BILATERAL L3-4, L4-5, L5-S1 FACET INJECTION. NO PATIENT COMPLICATIONS WERE NOTED. THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE FIR NEEDLE PLACEMENT. (B)(6) 2012: THE PATIENT PRESENTED WITH LOW BACK PAIN RADIATING DOWN LEFT LEG, LUMBAR RADICULAR PAIN, LUMBAR DEGENERATIVE DISC DISEASE. THE PATIENT UNDERWENT A LEFT L2-3 TRANSFORAMINAL EPIDURAL STEROID INJECTION (L2 NERVE ROOT) AND LEFT L3-4 TRANSFORAMINAL EPIDURAL STEROID INJECTION (L3 NERVE ROOT) UNDER FLUOROSCOPIC GUIDANCE. NO PATIENT COMPLICATIONS WERE REPORTED. (B)(6) 2012: THE PATIENT PRESENTED WITH LOW BACK PAIN RADIATING DOWN LEFT LEG, LUMBAR RADICULAR PAIN, LUMBAR DEGENERATIVE DISC DISEASE. THE PATIENT UNDERWENT A LEFT L4-5 TRANSFORAMINAL EPIDURAL STEROID INJECTION (L4 NERVE ROOT) AND LEFT L5-S1 TRANSFORAMINAL EPIDURAL STEROID INJECTION (L5 NERVE ROOT) UNDER FLUOROSCOPIC GUIDANCE. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6) 2012: THE PATIENT UNDERWENT A LUMBOSACRAL SPINE LAMINECTOMY (B)(6) 2013: THE PATIENT UNDERWENT A CT OF THE LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: MULTILEVEL DISCOGENIC DISEASE OF THE LUMBAR SPINE; L3-4, MILD CENTRAL STENOSIS AND MILD-TO-MODERATE LEFT GREATER THAN RIGHT NEUROFORAMINAL NARROWING IS UNCHANGED FROM PRIOR EXAM; L5-S1, STATUS POST INTERTRANSVERSE FUSION WITH SOLID BILATERAL POSTEROLATERAL FUSION MASSES IDENTIFIED WITHOUT CENTRAL STENOSIS, NO NEUROFORAMINAL NARROWING IS IDENTIFIED, CHRONIC BILATERAL L5 PARS DEFECT ARE REDEMONSTRATED; INTERVAL INCREASED SIZE OF A LEFT RENAL PELVIS CALCULUS MEASURING 1.5 CM WITH STABLE MINIMAL HYDROURETERONEPHROSIS.

Description of Event or Problem · 1

ON (B)(6) 1984 THE PATIENT REPORTEDLY UNDERWENT A L5-S1 POSTERIOR SPINAL FUSION PRESUMABLY FOR PARS DEFECT. ON (B)(6) 2005 THE PATIENT PRESENTED WITH LEFT LEG LACERATION. ON 13 APRIL 2011, IN A TELEPHONE ENCOUNTER, THE PATIENT WAS INFORMED THAT THE RESULTS OF THEIR MRI SHOWED CONSISTENCE WITH A SOLID BONY FUSION AT L4-5 AND L5-S1 WITH 2-MM DISC BULGE AT L3-4 AND MILD CENTRAL CANAL STENOSIS AT L3-4. THERE IS NERVE ROOT CANAL NARROWING DUE TO BROAD-BASED DISC PROTRUSION AND FACET HYPERTROPHY AT THE L3-4 LEVEL. THE DOCTOR FELT THAT IT WAS LIKELY THE PATIENT HAD CONTUSED THE 5TH LUMBAR NERVE. ON (B)(6) 2012 THE PATIENT PRESENTED WITH SEVERE SHARP LUMBAR BACK PAIN. ASSESSMENT: LUMBAR FACET ARTHROPATHY. THE PATIENT UNDERWENT A BILATERAL L3-4, L4-5, AND L5-S1 RADIOFREQUENCY ABLATION. MEDICATIONS: HYDROCODONE, FLEXERIL, IBUPROFEN. ON (B)(6) 2012 THE PATIENT PRESENTED WITH PAIN AND UNDERWENT RADIOGRAPHS WHICH SHOWED MILD TO MODERATE MULTILEVEL DEGENERATIVE CHANGE WITH MINIMAL BILATERAL L3-4 NEURAL FORAMINA NARROWING. DISC BULGE WITH POSTERIOR ANNULAR HIGH INTENSITY ZONE AT L4-5; AND BILATERAL RENAL SUB-CENTIMETER LESIONS WERE SUB-OPTIMALLY EVALUATED -WHILE THOSE MAY HAVE REPRESENTED RENAL CYSTS. ON (B)(6) 2012 (SIC) THE PATIENT REPORTEDLY UNDERWENT A S1-L5 BONE FUSION. ON (B)(6) 2012 PER BILLING RECORDS, THE PATIENT UNDERWENT VARIOUS LABS. ON (B)(6) 2012 THE PATIENT PRESENTED WITH SEVERE LUMBAR BACK PAIN. THE PATIENT UNDERWENT A BILATERAL L3-4, L4-5, AND L5-S1 FACET BLOCK. ON (B)(6) 2012 THE PATIENT PRESENTED WITH SHARP, WORSENING CENTRAL LOW BACK PAIN AND GENERAL MUSCLE AND JOINT STIFFNESS. MEDICATIONS: FLEXERIL, HYDROCODONE, XANAX, AND LIDODERM PATCH. ON (B)(6) 2012 THE PATIENT PRESENTED WITH CENTRAL LOW BACK, LEFT BUTTOCK, LEFT GROIN AND LEFT KNEE PAIN. THE PATIENT COMPLAINED THAT SEXUAL ACTIVITY CAUSED SHARP PAIN IN THE LOWER BACK. DIAGNOSIS: LUMBAR DEGENERATIVE DISC DISEASE AND LUMBAR SPONDYLOLISTHESIS. PER THE ENCOUNTER NOTES, THE PATIENT HAD UNDERGONE A LEFT L4-% TRANSFORAMINAL NERVE BLOCK WHICH PARADOXICALLY REPRODUCED A LOT OF PAIN. ON (B)(6) 2012 THE PATIENT PRESENTED LOW BACK PAIN AND MUSCLE SPASM. DIAGNOSIS: BULGING DISC, RADICULOPATHY, AND SACROILIITIS. (B)(6) 2012: THE PATIENT UNDERWENT A LUMBOSACRAL SPINE LAMINECTOMY. ON (B)(6) 2012 THE PATIENT PRESENTED WITH BACK PAIN AND UNDERWENT A BILATERAL LUMBAR SPINE L5-S1 FACET PARS BLOCK WITH FLUOROSCOPIC GUIDANCE. ON (B)(6) 2012 THE PATIENT PRESENTED WITH NEW BACK AND LEG PAIN. A LUMBAR SPINE MRI SHOWED AT L3-4, 2 MM RETROLISTHESIS AND 1 TO 2 MM DISC BULGE MILDLY NARROWING THE CANAL AND NEURAL FORAMINA WITHOUT NERVE ROOT IMPINGEMENT; L4-5 THERE HAD BEEN A HEMILAMINECTOMY AND POSTEROLATERAL SOLID BONE FUSION, THERE WAS NO CANAL STENOSIS; AT L5-S1 THERE WAS A 1 - 2 MM ANTEROLISTHESIS OF L5 WITH RESPECT TO S1. THERE WAS A BILATERAL POSTERIOR LATERAL SOLID FUSION. THERE WAS NO CANAL OR FORAMINAL STENOSIS. ON (B)(6) 2012 THE PATIENT PRESENTED FOR A PRE-OP EVALUATION. THE PATIENT UNDERWENT LABS WHICH REVEALED HIGH MCH LEVELS. A URINALYSIS SHOWED SOME BLOOD PRESENT AND WBC. AN ECG WAS BORDERLINE - POSSIBLE LEFT ATRIAL ENLARGEMENT. A CHEST X-RAYWAS UNREMARKABLE. ON (B)(6) 2012 THE PATIENT PRESENTED WITH LOW BACK PAIN AND LEFT BUTTOCK PAIN WITH THE PREOPERATIVE DIAGNOSIS OF PSEUDOARTHROSIS OF L5-S1 AND DEGENERATIVE DISC DISEASE. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF EXPLORATION OF FUSION MASSAT L5-S1; PLACEMENT OF INFUSE BMP AND CANCELLOUS BONE CHIPS FOR A POSTEROLATERAL ANTERIOR FACET FUSION. FLUOROSCOPY WAS UTILIZED THROUGHOUT. NO COMPLICATIONS WERE NOTED. PER THE OPERATIVE REPORT " ..THE LAMINA FROM L4-S1 WAS THEN DECORTICATED USING A MIDAS AND USING CANCELLOUS BONE CHIPS AND MEDIUM SIZED INFUSE BMP. THIS POSTEROLATERAL GUTTER ALONG WITH THE INTRA-LAMINAR SPACE IN THE FACETS WAS GRAFTED FOR FUSION FROM L4-S1&#26464;NO PATIENT COMPLICATIONS WERE NOTED. AN ECG DEMONSTRATED A POSSIBLE LEFT ATRIAL ENLARGEMENT. ON (B)(6) 2012 THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2013 THE PATIENT PRESENTED IN PT WITH DEGENERATIVE DISC DISEASE AND LUMBAR STRAIN. ON (B)(6) 2013 THE PATIENT PRESENTED WITH BACK PAIN WITH RADICULITIS AND THE DIAGNOSIS OF SACROILIITIS AND UNDERWENT A LEFT S1 JOINT INJECTION. NO PATIENT COMPLICATIONS WERE NOTED. ON 17 JUNE 2013 PER A PATIENT EMAIL, THE PATIENT REPORTED BAD PAIN. ON 18 JUNE 2013 PER A PATIENT EMAIL, THE PATIENT REPORTED PAIN AND BEING ASKED TO WEAR A &#49298;ACE NOW (REVEARSAL).. " ON (B)(6) 2013 THE PATIENT PRESENTED IN ER X 2 WITH INCREASING LOW BACK PAIN WITH BURNING DOWN THE LEFT LEG, LUMBAR SPRAIN, POSSIBLE SCIATICA. THE PATIENT UNDERWENT VARIOUS LABS WHICH WERE NEGATIVE. (B)(6)2012: THE PATIENT PRESENTED WITH LOW BACK PAIN. PREVIOUS MRI SHOWS THE PATIENT HAS DEGENERATIVE DISK DISEASE IN MULTIPLE LEVELS THAT ARE MILD. HE ALSO HAS MILD FORAMINAL STENOSIS AT L3-4. CAT SCAN SHOWS PARS DEFECTS ARE PRESENT BILATERALLY AT L5. THERE IS ATTEMPTED FUSION ON L5-S1 WITH NON-INSTRUMENTED POSTERIOR FUSION, HOWEVER, THE L5 DOES NOT SEEM TO BE FUSE TO S1. ASSESSMENT: LOW BACK PAIN WITH PSEUDOARTHROSIS OF L5-S1. (B)(6)2013 : THE PATIENT UNDERWENT X-RAYS OF THE LUMBOSACRAL SPINE. (B)(6) 2013: THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE. FINDINGS: THERE ARE SMALL OSTEOPHYTES ABOUT THE LOWER LUMBAR SPINE WITHOUT SIGNIFICANT DISC SPACE NARROWING. IMPRESSION: SPONDYLOSIS OF THE SPINE; THERE IS RENAL CALCULUS. ON (B)(6) 2013 THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE. IMPRESSION: POSTERIOR FUSION L3-S1, NO SIGNIFICANTLY CHANGED.

Description of Event or Problem · 1

ON (B)(6) 2012 THE PATIENT PRESENTED WITH ACQUIRED SPONDYLOLISTHESIS AND MYOFASCIAL PAIN SYNDROME. ON (B)(6) 2012 THE PATIENT UNDERWENT AN ECG WHICH SHOWED A NORMAL SINUS RHYTHM BUT A POSSIBLE LEFT ATRIAL ENLARGEMENT. ON (B)(6) 2013 THE PATIENT PRESENTED WITH PAIN IN THE LEFT SIDE LOW BACK AND LEFT POSTERIOR CHEST WALL. WORSENING DAILY MUSCLE SPASMS WERE THE PATIENT'S OVERWHELMING COMPLAINT. IT WAS REPORTED THAT THE SPASMS WERE "EXTREMELY DISRUPTIVE" WITH DAILY ACTIVITIES. IMPRESSION: LUMBAR DYSTONIA, CHRONIC LOW BACK PAIN, AND NICOTINE DEPENDENCE. ON (B)(6) 2013 THE PATIENT PRESENTED WITH PAIN SIGNIFICANT DYSTONIC MUSCLE SPASMS. THE PATIENT UNDERWENT BOTOX INJECTIONS INTO THE LEFT LUMBAR CHEST AND LEFT LUMBAR PARASPINOUS MUSCULATURE. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6) 2010: PER THE PATIENT'S LOG OF "BACK PAIN DOCTOR HISTORY," THE PATIENT WENT TO THE CHIROPRACTOR FOR BACK PAIN AND WAS TO WEAR A BACK BRACE. (B)(6) 2010: THE PATIENT REPORTED NO RELIEF FROM PAIN. (B)(6) 2011: PER THE PATIENT'S LOG OF "BACK PAIN DOCTOR HISTORY," THE PATIENT WAS PRESCRIBED GABAPENTIN 300 MG X 6 PD AND IBUPROFEN 800 MG. (B)(6) 2011: PER THE PATIENT'S LOG OF "BACK PAIN DOCTOR HISTORY," THE PATIENT WAS PRESCRIBED INDOMETHACIN ER 75 MG. (B)(6) 2011: PER THE PATIENT'S "BACK DIARY" LOG, THE PATIENT UNDERWENT A FACET BLOCK. (B)(6) 2012: PER THE PATIENT'S LOG OF "BACK PAIN DOCTOR HISTORY," THE PATIENT WAS PRESCRIBED BACLOFEN 10 MG, HYDROCODONE-ACETAMINOPHEN 5-500. (B)(6) 2012: PER THE PATIENT'S LOG OF "BACK PAIN DOCTOR HISTORY," THE PATIENT UNDERWENT A L3-4 STEROID INJECTION AND AN MRI WITH CONTRAST. MEDICATIONS: LIDODERM PATCH AND HYDROCODONE ACETAMINOPHEN 10/325, METAXAIONE 800MG, AND METHYL PREDNISONE 4MG FOR 6 DAYS, ON (B)(6) 2012 SAGITTAL AND STIR IMAGES OF THE LUMBAR SPINE WERE OBTAINED FOR EVALUATION AND SHOWED LIKELY HEMANGIOMAS ARE SEEN WITHIN T11, L 1 AND L2 VERTEBRAL BODIES. MODIC TYPE 11 CHANGES WITHIN THE POSTERIOR INTERIOR ENDPLATE OF L3 WERE NOTED. THERE WAS NO ACUTE FRACTURE. MULTILEVEL DISC DESICCATION WITH MILD DISC HEIGHT LOSS AT L3-L4 AND A LIKELY SCHMORL'S NODE WITHIN THE INFERIOR END PLATE OF L3 WERE NOTED. A SMALL DISC AT L5-S1 WAS LIKELY CONGENITAL. SUB-CENTIMETER LESIONS WITHIN BOTH KIDNEYS WERE SUB-OPTIMALLY EVALUATED. THESE APPEARED HYPERINTENSE ON T2 AND HYPONTENSE ON T1 SUGGESTIVE OF CYSTIC LESIONS; HOWEVER THIS WAS NOT WELL EVALUATED. NORMAL LUMBOSACRAL LORDOSIS WAS PRESERVED. CONUS ENDED AT T12-L1. THE DISTAL THORACIC SPINAL CORD AND CONUS MEDULLARIS ARE NORMAL IN THEIR SIZE, SHAPE, AND SIGNAL INTENSITY ON ALL PULSE SEQUENCES. (B)(6) 2012: PER THE PATIENT'S "BACK DIARY" LOG, THEY UNDERWENT A CORTISONE INJECTION AT THE PAIN SITE. (B)(6) 2012: PER THE PATIENT'S LOG OF "BACK PAIN DOCTOR HISTORY," THE PATIENT PRESENTED FOR A CONSULTATION ON PAIN. CICLOFENAC SODIUM 75MG WAS PRESCRIBED. (B)(6) 2012: PER THE PATIENT'S "BACK DIARY" LOG, THE PATIENT UNDERWENT A FACET BLOCK. (B)(6) 2012: PER THE PATIENT'S LOG OF "BACK PAIN DOCTOR HISTORY," "PAIN WAS BACK AGAIN." (B)(6) 2012: PER THE PATIENT'S LOG OF "BACK PAIN DOCTOR HISTORY," THE PATIENT UNDERWENT X-RAYS (B)(6) 2012: PER THE PATIENT'S LOG OF "BACK PAIN DOCTOR HISTORY," THE DOCTORS SUGGESTED "S1 JOINT MAY BE AN ISSUE." (B)(6) 2012: PER THE PATIENT'S LOG OF "BACK PAIN DOCTOR HISTORY," THE PATIENT REPORTED THE DOCTOR SAID HE HAD BULGED DISCS AND THAT THE PATIENT HAD NO HOPE OF WALKING OR STANDING AGAIN. (B)(6) 2012: THE PATIENT COMPLAINED OFF CHRONIC LOWER BACK PAIN, LEFT HIP PAIN, LEFT SIDE MUSCLE SPASM WHEN ACTIVE, AND INTENSE LEFT HIP AND BUTTOCK PAIN. THE PATIENT ALSO REPORTED THAT THEY "COULD NOT STAND OR WALK ANY DISTANCE." (B)(6) 2013: THE PATIENT PRESENTED WITH SOME CONTINUED PAIN IN THE LUMBAR SPINE BUT NO TINGLING, NUMBNESS OR WEAKNESS IN THE LOWER EXTREMITIES. THE PATIENT WAS TO START PHYSICAL THERAPY. LUMBAR SPINE X-RAYS SHOWED ALIGNMENT WAS WELL MAINTAINED. THERE WAS MATURE PARASPINOUS GRAFT MATERIAL ABOUT THE LUMBOSACRAL JUNCTION. THERE WERE SMALL OSTEOPHYTES ABOUT L3-S1 LEVELS. MILD NARROWING AND MODERATE HYPERTROPHIC CHANGES ABOUT THE L5-S1 DISC SPACE WERE NOTED ALONG WITH A TRANSITIONAL ANATOMY. THERE IS NO FRACTURE OR SUBLUXATIONS. (B)(6) 2013: THE PATIENT REPORTED NO PROGRESS WITH LEFT SIDED BACK PAIN AND MUSCLE SPASM. THE PATIENT DESCRIBED PAIN THAT WAS ALONG THE RIBS ON THE LEFT SIDE OF BACK AND RADIATED DOWN THE LEFT HIP. (B)(6) 2013: THE PATIENT, APPROX. 2 MO. POST OP., PRESENTED WITH PERSISTENT MUSCLE SPASM IN THE RIGHT LOWER BACK DESCRIBED AS INTERMITTENT BUT SEVERELY DEBILITATING. THE PATIENT WAS UTILIZING A TENS UNITS AND TAKING FLEXERIL WITH NO RELIEF. LUMBAR SPINE FILMS SHOWED GOOD ALIGNMENT WITH INTERVAL BONY FUSION. (B)(6) 2013: THE PATIENT PRESENTED WITH BACK PAIN. DIAGNOSIS: ARTHRODESIS AND LUMBAGO. (B)(6) 2013: THE PATIENT PRESENTED WITH DEGENERATIVE DISC DISEASE AND LUMBAR STRAIN. THE PATIENT REPORTED NO PROGRESS WITH LEFT SIDED BACK PAIN AND MUSCLE SPASM. THE PATIENT WAS UTILIZING A BRACE AT WORK. (B)(6) 2013: THE PATIENT, APPROX. 5 MO. POST OP., PRESENTED WITH LOW BACK PAIN AND PAIN IN LEFT BUTTOCK. (B)(6) 2013: THE PATIENT PRESENTED WITH SYMPTOMS RELATED TO THE LEFT SACROILIAC JOINT. THE PATIENT REPORTED THE PAIN WAS WORSE SINCE RECEIVING A S1 JOINT INJECTION THE WEEK PRIOR. THE PATIENT WAS UTILIZING A CORSET WHICH HE FOUND HELPFUL. THE PATIENT ALSO STATED THEY WERE IN CONSTANT PAIN. THE PATIENT WAS EXQUISITELY TENDER OVER THE LEFT BUTTOCK AND LEFT S1 JOINT (B)(6) 2013: THE PATIENT UNDERWENT A RETROPERITONEAL ULTRASOUND WHICH SHOWED NO HYDRONEPHROSIS; POSSIBLE SMALL CALCULUS IN THE RIGHT KIDNEY; AND MULTIPLE SMALL SIMPLE CYSTS IN THE RIGHT KIDNEY.

Description of Event or Problem · 1

"IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT PRESENTED WITH THE CHIEF COMPLAINTS OF PAIN IN PENIS <(>&<)> TESTICLE, PAIN AFTER URINATION AND ALSO HAD RINGING IN LEFT EAR. HE DESCRIBED THE PAIN AS CONSTANTLY BURNING ABOUT 3 WEEKS AROUND PENIS. ASSESSMENT: DYSURIA. ON (B)(6) 2010 THE PATIENT PRESENTED FOR THE FOLLOW UP ON LAB RESULTS. HE REPORTEDLY INDICATED ITCHING OF URETHRA. ASSESSMENT: URETHRITIS; PROSTATITIS. URINALYSIS WAS NEGATIVE (B)(6) 2010 THE PATIENT PRESENTED WITH THE CHIEF COMPLAINT OF LEFT LOWER BACK PAIN X 2 WEEKS. THE PATIENT STATED THAT IT WAS PAINFUL AND BURNING WHILE URINATING. HE ALSO REPORTED FREQUENT URINATION. THERE WAS TENDERNESS ON THE LATERAL ROTATION OF LEFT THORACIC BACK T8-L1. URINALYSIS WAS NEGATIVE. ASSESSMENT: DYSURIA; LEFT THORACIC MUSCLE STRAIN."

Description of Event or Problem · 1

IT WAS REPORTED THAT : ON AN UNKNOWN DATE, THE PATIENT COMPLAINED OF LOW BACK AND LOWER EXTREMITY PAIN. ON (B)(6) 2011 THERE WAS BONY FUSION AT L5-S1. ON PHYSICAL EXAMINATION, THERE WAS TIGHTNESS OF PARASPINAL MUSCLES TO THE LEFT OF MIDLINE. DIAGNOSIS: LEFT SCIATICA; STATUS POST LUMBAR SURGERY X2 WITH A LUMBAR FUSION AT L5-S1 IN 1984 AND A DISCECTOMY IN 2002; RULE OUT SPINAL STENOSIS AT L4-5. ON (B)(6) 2011 THE PATIENT PRESENTED WITH THE HISTORY OF STATUS-POST FUSION AT L4-5, NEW BACK PAIN AND LEG PAIN; RULE OUT STENOSIS AND HE UNDERWENT MRI OF THE LUMBAR SPINE. ON (B)(6) 2011: THE PATIENT PRESENTED WITH DIAGNOSES OF LUMBAR RADICULOPATHY AND DISC HERNIATION AS WELL AS POST LAMINECTOMY SYNDROME. 0ON (B)(6) 2011 THE PATIENT PRESENTED TO CONSULT "RE" PA IN LEFT MID TO LOWER BACK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
399718 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111101AA1

Patients

Seq Age Sex Outcome Treatment
1 Other| R