FDA Adverse Event Injury Summary report: N

INFUSE BONE GRAFT

MDR report key: 2936181 · Received January 30, 2013

Report

Report Number
1030489-2013-00317
Event Type
Injury
Date Received
January 30, 2013
Report Date
February 18, 2016
Manufacturer
MEDTRONIC SOFAMOR DANEK USA, INC
Product Code
NEK
PMA / PMN Number
P000058
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
PATIENT

Narratives

Additional Manufacturer Narrative · 1

(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 USED 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

ADDITIONAL INFORMATION : (B)(6).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT HAS "SIGNIFICANT PAIN AND MAJOR NERVE INJURIES."

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2006: PATIENT UNDERWENT PA AND LATERAL CHEST X-RAY. IMPRESSION: NO EVIDENCE OF ACUTE CARDIOPULMONARY DISEASE. ON (B)(6) 2006: PATIENT UNDERWENT TWO CHEST VIEWS PA/LAT. IMPRESSION: NEGATIVE CHEST. ON (B)(6) 2006: PATIENT PRESENTED WITH FOLLOWING DISCHARGE DIAGNOSIS: ACUTE SINUSITIS; EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE; RESTLESS LEG SYNDROME; HYPOTHYROIDISM; GASTROESOPHAGEAL REFLUX DISEASE; DEPRESSION; HISTORY OF INSOMNIA; PERIPHERAL NEUROPATHY; OSTEOARTHRITIS. PATIENT UNDERWENT CHEST PA/LAT X-RAY. IMPRESSION: THERE IS NO EVIDENCE OF ACUTE DISEASE. ON (B)(6) 2007: PATIENT UNDERWENT ABDOMEN AND PELVIS CT SCAN WITHOUT CONTRAST. IMPRESSION: NO ACTIVE ABDOMEN OR PELVIC DISEASE BY A CT WITH ORAL CONTRAST ONLY. IF COLONIC PATHOLOGY REMAINS SUSPECTED CONSIDER COLONOSCOPY FOLLOW UP; CHOLELISTHIASIS IS EVIDENT WITHOUT FINDINGS OF CHOLECYSTITIS BY CT SCAN. ON (B)(6) 2007: PATIENT PRESENTED WITH HYPOTHYROIDISM, DEPRESSION, COPD, AND OSTEOARTHRITIS. ON (B)(6) 2007: PATIENT UNDERWENT THE FOLLOWING PROCEDURE: ESOPHAGOGASTRODUODENOSCOPY. IMPRESSION: ANTRAL GASTRITIS; NODULAR MUCOSA IN THE DUODENAL BULB. ON (B)(6) 2007: PATIENT UNDERWENT COLONOSCOPY. IMPRESSION: A FEW DIVERTICULOSIS. INTERNAL HEMORRHOIDS; FAIR PREP. ON (B)(6) 2007: PATIENT UNDERWENT "ERCP". IMPRESSION: PARTIAL OPACIFICATION OF THE PANCREATIC DUCT. OTHERWISE UNREMARKABLE. ON (B)(6) 2007: PATIENT PRESENTED WITH CHOLECYSTITIS. UNDERWENT THE PROCEDURE LAPAROSCOPIC CHOLECYSTECTOMY. ON (B)(6) 2007: PATIENT UNDERWENT CHEST PA/LAT X-RAY. IMPRESSION: NORMAL CHEST. ON (B)(6) 2008: PATIENT PRESENTED WITH LUMBAR SPINE X-RAY. IMPRESSION: NO ACUTE FRACTURE OR DISLOCATION. MINIMAL LEVOCONVEX SCOLIOSIS; SATISFACTORY POSITION OF METALLIC HARDWARE STATUS POST FUSION OF L2-4 VERTEBRAL BODIES. ON (B)(6) 2011: PATIENT UNDERWENT CT SCAN OF A/P WITH CONTRAST. IMPRESSION: NO DEFINITE EVIDENCE ACUTE INTRA-ABDOMINAL PROCESS. DILATED COMMON BILE DUCT STATUS POST CHOLECYSTECTOMY POSSIBLE COMPENSATORY. RECOMMEND CORRELATION WITH LABORATORY VALUES. MRCP CAN BE OBTAINED IF THERE IS BIOCHEMICAL EVIDENCE FOR BILIARY OBSTRUCTION. HYSTERECTOMY. CORONARY ARTERIAL ATHEROSCLEROSIS. ON (B)(6) 2010: PATIENT UNDERWENT X-RAY OF CHEST PA/LAT. IMPRESSION: NO EVIDENCE OF ACUTE CARDIOPULMONARY DISEASE. ON (B)(6) 2011: PATIENT PRESENTED WITH ABDOMINAL PAIN AND UNCLEAR ETIOLOGY. ON (B)(6) 2011: PATIENT UNDERWENT CT SCAN OF LUMBAR SPINE. IMPRESSION: NO EVIDENCE OF SPINAL STENOSIS. RIGHT PEDICLE SCREWS AT L5 AND S1 POSSIBLY COMPROMISING THE RIGHT LATERAL RECESS IN THE EXITING NERVE ROOTS. ON (B)(6) 2012: PATIENT PRESENTED WITH DOG BITE. ON (B)(6) 2012: PATIENT PRESENTED WITH BACKPAIN AND HEAD AND NECK PAIN. ON (B)(6) 2013: PATIENT UNDERWENT TWO CHEST VIEW. IMPRESSION: NO EVIDENCE OF AN ACUTE CARDIOPULMONARY PROCESS. ON (B)(6) 2015: PATIENT UNDERWENT CT SCAN OF A/P WITH CONTRAST. IMPRESSION: NO EVIDENCE OF ACUTE PROCESS IN THE ABDOMEN OR PELVIS.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON, (B)(6) 2014: PATIENT PRESENTED FOR FOLLOW-UP WITH BACK PAIN. (B)(6) 2014, : PATIENT PRESENTED FOR FOLLOW UP OF CHRONIC CONDITIONS. 16 DEC 2014: PATIENT UNDERWENT X-RAY OF THE CHEST. IMPRESSION: LEFT UPPER LOBE NODULAR DENSITY. NO EVIDENCE OF ACUTE CARDIOPULMUNORY DISEASE. (B)(6) 2015: THE PATIENT UNDERWENT X-RAY OF CHEST. IMPRESSION: LESS APPARENT NODULAR OPACITY IN LEFT UPPER LOBE. (B)(6) 2015: THE PATIENT UNDERWENT UPPER GI ENDOSCOPY. IMPRESSION: NORMAL ESOPHAGUS. ERYTHEMATOUS MUCOSA IN THE ANTRUM. BIOPSIED. A SINGLE GASTRIC POLYP. BIOPSIED.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON 2001 PATIENT UNDERWENT MRI FOR LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: MILD DEGENERATIVE CHANGES AT L4-5 AND L5 S1 WITHOUT HIGH GRADE CENTRAL OR FORAMINAL ENCROACHMENT. ON (B)(6) 2002 PATIENT PRESENTED WITH LOW BACK PAIN AND LEG PAIN. ON (B)(6) 2002 PATIENT UNDERWENT X-RAY OF LUMBAR SPINE AP AND/OR LATERAL DUE TO PEDICAL SCREWS. RESULT: A SINGLE LATERAL VIEW OF THE LUMBAR SPINE DEMONSTRATES PEDICULAR SCREWS TRANSFIXING THE L4 AND L5 VERTEBRAL BODIES AND THE S1 SACRAL SEGMENT. THE PATIENT IS STATUS POST APPARENT ANTERIOR FUSION AT THE L4-5 LEVEL. SATISFACTORY POSITION IS SEEN IN THIS ONE PROJECTION. PATIENT ALSO UNDERWENT X-RAY OF LATERAL LUMBAR SPINE IN THE OR. RESULT: SURGICAL INSTRUMENTS ARE IDENTIFIED POSTERIOR TO THE LEVEL OF L5 AT THE LEVEL OF THE SPINOUS PROCESS AND LAMINA. ON (B)(6) 2002 PATIENT UNDERWENT X-RAY OF LUMBAR SPINE DUE TO BACK PAIN. IMPRESSION: POST SURGICAL CHANGES ARE SEEN. ON (B)(6) 2002 PATIENT UNDERWENT X-RAY OF AP AND LATERAL LUMBAR SPINE DUE TO BACK PAIN. IMPRESSION: THERE ARE DISC SPACE PROSTHESES PRESENT AS WELL AS PEDICULAR PLATE AND SCREWS AT 4-5 AND 5-S1. ALIGNMENT IS ANATOMIC. ON (B)(6) 2002 PATIENT UNDERWENT X-RAY OF AP AND LATERAL LUMBAR SPINE WITH FLEXION AND EXTENSION DUE TO LOWER BACK PAIN. IMPRESSION: POST SURGICAL CHANGES WITHOUT INSTABILITY. ON (B)(6) 2002 PATIENT UNDERWENT X-RAY OF LUMBAR SPINE WITH FLEXION AND EXTENSION DUE TO BACK PAIN. IMPRESSION: STATUS POST POSTERIOR FUSION OF L4 THROUGH S1 WITH NO EVIDENCE OF COMPLICATION AND NO EVIDENCE OF INSTABILITY. ON (B)(6) 2002 PATIENT UNDERWENT X-RAY FOR LUMBAR SPINE DUE TO BACK PAIN. IMPRESSION: S/P SURGICAL CHANGES WITHOUT EVIDENCE OF INSTABILITY. ON (B)(6) 2003 PATIENT UNDERWENT MRI OF LUMBAR SPINE WITH CONTRAST DUE TO BACK PAIN. IMPRESSION: POST SURGICAL CHANGES ARE SEEN. ON (B)(6) 2003 PATIENT UNDERWENT X-RAY OF LUMBAR SPINE WITH FLEXION AND EXTENSION DUE TO BACK PAIN. IMPRESSION: POST SURGICAL CHANGES WITHOUT ABNORMAL MOTION WITH FLEXION OR EXTENSION. 2. NO SIGNIFICANT CHANGE SINCE PREVIOUS EXAM. ON (B)(6) 2004 PATIENT PRESENTED WITH PERSISTENT NUMBNESS, TINGLING AND SHOOTING PAIN IN LOWER EXTREMITIES AND LOWER BACK PAIN AND LIMITATION OF FUNCTION. ON (B)(6) 2004 PATIENT UNDERWENT MYELOGRAM INJECTION AND TOLERATED THE PROCEDURE WELL. PATIENT UNDERWENT PLAIN FILM, FLEXION AND EXTENSION, AND POST CONTRAST CT IMAGING. IMPRESSION: STATUS POST POSTERIOR FUSION FROM L4 TO S1 WITHOUT EVIDENCE OF COMPLICATION. SATISFACTORY DECOMPRESSION OF CENTRAL CANAL; MILD DEGENERATIVE CHANGES OF THE FUSION AT L3-4 AND L2-3 WITHOUT FOCAL DISC ABNORMALITY OR SIGNIFICANT CENTRAL CANAL STENOSIS; NO DYNAMIC INSTABILITY WITH FLEXION AND EXTENSION. ON (B)(6) 2004 PATIENT PRESENTED WITH MYELOGRAM WHICH SHOWS PRIOR FUSION TO BE SOLID. THERE IS NO EVIDENCE OF ANY SIGNIFICANT NERVE IMPINGEMENT. ON (B)(6) 2005 PATIENT ADMITTED WITH PREOPERATIVE DIAGNOSIS OF LARGER GOITER WITH AIRWAY COMPRESSION AND SYMPTOMATIC OBSTRUCTION. PATIENT UNDERWENT TOTAL THYROIDECTOMY WITH BILATERAL NERVE INTEGRITY MONITORING. ON (B)(6) 2005 PATIENT UNDERWENT ULTRASOUND FOR SOFT TISSUE NECK. IMPRESSION: POSSIBLE SMALL NODE AS DESCRIBED, FURTHER CLINICAL COR RELATION AND FOLLOW UP IS NECESSARY. ON (B)(6) 2008 PATIENT UNDERWENT LUMBAR SPINE MRI WITH AND WITHOUT CONTRAST. IMPRESSION: L4 THROUGH S1 POSTERIOR FUSION WITH DISC IN TERPOSITION BUT NO FINDINGS OF RECURRENT DISC, HARDWARE FAILURE OR SIGNIFICANT STENOSIS. ON (B)(6) 2008 PATIENT UNDERWENT LUMBAR MYELOGRAM DUE TO BACK PAIN RADIATING TO LEFT LEG AND LATERAL ASPECT OF THE BODY, LEFT LEG NUMBNESS, BLADDER INCONTINENCE, LOWER EXTREMITY WEAKNESS, HISTORY PRIOR LUMBAR SPINE FUSION. IMPRESSION: STATUS POST LUMBAR SPINE FUSION FROM L4 THROUGH S1 WITHOUT FINDINGS TO SUGGEST HARDWARE LOOSENING OR HARDWARE FAILURE; MILD CENTRAL CANAL STENOSIS AT L3-L4 WITH CUT OFF OF NORMAL FILLING OF THE L3 NERVE ROOT SLEEVES BILATERALLY; MILD MODERATE CENTRAL CANAL STENOSIS AT L2-L3. PATIENT UNDERWENT LUMBAR SPINE FLEXION/EXTENSION TEST. IMPRESSION: NEGATIVE FOR LUMBAR INSTABILITY. PATIENT UNDERWENT CT LUMBAR SPINE, POST MYELOGRAM. IMPRESSION: STATUS POST LUMBAR SPINE FUSION FROM L4 THROUGH S1. NO FINDINGS TO SUGGEST HARDWARE LOOSENING OR HARDWARE FAILURE. STABLE APPEARANCE OF THE CENTRAL CANAL AND FORAMINA AT THE LEVEL OF FUSION; PROGRESSION OF MILD DEGENERATIVE CHANGES AT L2-L3 AND L3-L4 AS DESCRIBED. AT L2-L3, THERE IS MILD CENTRAL CANAL STENOSIS WHICH HAS SLIGHTLY WORSENED WHEN COMPARED WITH THE PRIOR STUDY. AT L3-L4, THERE MILD BILATERAL FORAMINAL STENOSIS AND MINIMAL CENTRAL CANAL STENOSIS WHICH HAS PROGRESSED SLIGHTLY WHEN COMPARED WITH PRIOR STUDY. ON (B)(6) 2008 PATIENT PRESENTED FOR FOLLOW UP OF LUMBAR SPINE. PATIENT HAD A CT MYELOGRAM WHICH SHOWS GOOD SOLID FUSION AT L4-L5 AND L5-S1. HARDWARE IS IN PLACE AND INTACT. ON (B)(6) 2008 PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF: LUMBAR SPINAL STENOSIS; DEGENERATIVE DISC DISEASE; LUMBAR RADICULOPATHY; MECHANICAL LOW BACK PAIN. PATIENT UNDERWENT FOLLOWING OPERATIONS: REMOVAL OF SEGMENTAL HARDWARE AT L4-S1; EXPLORATION OF FUSION; REVISION OF L4, COMPLETE L3, PARTIAL L2, LAMINECTOMY, PARTIAL FACETECTOMY AND BILATERAL FORAMINOTOMIES; POSTERIOR INSTRUMENTED FUSION L2 TO L4 WITH INFUSE LOCAL ALLOGRAFT BONE AND DEMINERALIZED BONE MATRIX. PER OP NOTES, THE FACET JOINTS AND TRANSVERSE PROCESSES WERE DECORTICATED BILATERALLY FROM L2 TO L4 AND SUBSEQUENTLY BONE GRAFT CONSISTING OF INFUSE LOCAL ALLOGRAFT BONE AND DEMINERALIZED BONE MATRIX WAS PACKED INTO LATERAL GUTTERS AS WELL AS INTO THE DECORTICATED FACET JOINTS. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2008 PATIENT PRESENTED FOR FIRST POSTOPERATIVE VISIT. PATIENT UNDERWENT X-RAY FOR AP AND LATERAL LUMBAR SPINE WHICH SHOES POSTERIOR PEDICLE SCREW INSTRUMENTATION L2 TO L4 AND PREVIOUS FUSION AT L4-L5 AND L5-S1. NO EVIDENCE OF HARDWARE FAILURE. ON (B)(6) 2008 PATIENT PRESENTEDFOR FOLLOW UP. DOCTOR¿S RECOMMENDATION WAS REVISION INSTRUMENTED FUSION AND TO BASICALLY EXTEND FUSION BACK DOWN TO THE SACRUM AND ADD ADDITIONAL BONE GRAFT AND BONE STIMULATOR. ON (B)(6) 2008 PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF: MECHANICAL LOW BACK PAIN; KYPHOTIC DEFORMITY OF THE LUMBAR SPINE; PSEUDOARTHRITIS. PATIENT UNDERWENT FOLLOWING OPERATIONS: PARTIAL REMOVAL OF HARDWARE, L2-L4; EXPLORATION OF FUSION; POSTERIOR ARTHRODESIS, L4-L5 AND L5-S1. LEGACY 5.5 INSTRUMENTATION SYSTEMS WAS USED. PER OP NOTES, THE BONE GRAFT CONSISTED OF INFUSE, ALLOGRAFT BONE, AND DEMINERALIZED BONE MATRIX INTO THE LATERAL GUTTERS AND SUBSEQUENTLY ONCE THE BONE GRAFT WAS IN PLACE, HEMOSTASIS WAS ACHIEVED. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2008 PATIENT PRESENTED FOR FIRST POSTOPERATIVE VISIT. DOCTOR RENEWED VICODIN AND INCREASED LYRICA TO 75MG. ON (B)(6) 2009 PATIENT PRESENTED FOR FOLLOW UP OF LUMBAR SPINE. DOCTOR ADVISED LYRICA. ON (B)(6) 2010 PATIENT PRESENTED FOR FOLLOW UP OF MULTILEVEL LUMBAR DECOMPRESSION AND POSTERIOR INSTRUMENTED FUSION. DOCTOR ADVISED LYRICA. ON (B)(6) 2010 PATIENT UNDERWENT X-RAY FOR LUMBAR SPINE. IMPRESSION: STATUS POST LUMBOSACRAL SPINE FUSION. NO EVIDENCE OF LUMBOSACRAL SPINE FRACTURE OR HARDWARE FAILURE. THERE IS 4 MM OF RETROLISTHESIS AT L3-L4 WHICH IS PROBABLY CHRONIC. ON (B)(6) 2010 PATIENT PRESENTED FOR FOLLOW UP. DOCTOR¿S IMPRESSION WAS PRIMARY UPPER LUMBAR/LOWER THORACIC PAIN. ON (B)(6) 2011 PATIENT PRESENTED WITH PERSISTENT PAIN IN HER LEG, LEFT GREATER THAN RIGHT. PATIENT UNDERWENT X-RAY OF LS SPINE WHICH SHOWS POSTERIOR PEDICLE SCREW INSTRUMENTATION L2 TO S1 WITH TRANSFORAMINAL LUMBAR INTERBODY GRAFTS AT L4-L5 AND L5-S1. THERE IS NO EVIDENCE OF HARDWARE FAILURE. THERE DOES NOT APPEAR TO BE A SIGNIFICANT AMOUNT OF BONE IN THE LATERAL RECESSES, LEFT GREATER THAN RIGHT. IMPRESSION: LOW BACK PAIN; LUMBAR RADICULOPATHY ON (B)(6) 2011 PATIENT UNDERWENT CT LUMBAR SPINE WITHOUT CONTRAST DUE TO LUMBAR RADICULOPATHY. ON (B)(6) 2011 PATIENT PRESENTED WITH LUMBAR CT SCAN WHICH SHOWS EVIDENCE OF POSTERIOR PEDICLE SCREW INSTRUMENTATION L2 TO S1. THERE IS NO EVIDENCE OF HARDWARE FAILURE. HOWEVER, THE RIGHT PEDICLE SCREWS AT L5 AND S1 POSSIBLEY COMPROMISE THE RIGHT LATERAL RECESS EXITING NERVE ROOT. ON (B)(6) 2011 PATIENT PRESENTED FOR FOLLOW UP. DOCTOR REVIEWED CT SCAN WHICH SHOWS SOLID APPEARING FUSION. FROM PRIOIR CT IT WAS NOTED TO HAVE POSSIBLE COMPROMISE INVOLVING THE L5-S1 RIGHT PEDICLE SCREWS. ON (B)(6) 2011 PATIENT PRESENTED WITH LOW BACK, BILATERAL LOWER EXTREMITY PAIN. DOCTOR¿S ASSESSMENT WAS: LOW BACK, BILATERAL LOWER EXTREMITY RADICULOPATHY; PRESUMABLY FAILED BACK SURGERY SYNDROME. ON (B)(6) 2011 PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF: HAMMERTOE DEFORMITY, SECOND, THIRD AND FOURTH, RIGHT FOOT; CONTRACTION DEFORMITY, SECOND, THIRD AND FOURTH, RIGHT FOOT. PATIENT UNDERWENT FOLLOWING PROCEDURES: HAMMERTOE CORRECTION WITH PRO TOE IMPLANT, SECOND, THIRD AND FOURTH DIGITS; TENOTOMY, SECOND, THIRD AND FOURTH EXTENSOR TENDONS; EXCISION OF EXOSTOSIS, DISTAL PHALANX, SECOND TOE. ON (B)(6) 2012 PATIENT PRESENTED WITH SIGNIFICANT LEFT SIDED PAIN AND TENDERNESS THROUGH THE LEFT SIDE. DOCTOR¿S ASSESSMENT WAS NECK PAIN AND LEFT CERVICAL RADICULOPATHY. LEFT LOWER EXTREMITY PAIN COULD ALSO BE SECONDARY TO HER NECK. ON (B)(6) 2012 PATIENT UNDERWENT MRI OF CERVICAL SPINE. IMPRESSION: MULTILEVEL SPONDYLOSIS. DEGENERATIVE FINDINGS LOOK MOST PRONOUNCED AT C4-5, C5-6, AND C6-7. AT THESE LEVELS THERE IS FORAMINAL STENOSIS WITHOUT SUGGESTION OF SIGNIFICANT CENTRAL STENOSIS. ON (B)(6) 2012 PATIENT PRESENTED FOR FOLLOW UP. DOCTOR REVIEWED MRI C SPINE WHICH SHOWS MULTILEVEL DISC OSTEOPHYTE COMPLEXES WITH EVIDENCE OF CERVICAL KYPHOSIS. ON (B)(6) 2012 PATIENT PRESENTED WITH LEFT SIDED NECK PAIN AND INTERMITTENT RADICULOPATHY DOWN HER LEFT ARM. PATIENT UNDERWENT SPINAL TESTS CERVICAL-VERTEBRAL ARTERY TEST WHICH INDICATES A VERTIBRA-BASLLAR INSUFFICIENCY. DOCTOR¿S ASSESSMENT: NECK PAIN IS CREATING SIGNIFICANT PAIN/DISABILITY DURING ROUTINE ADLS SUCH AS SLEEP DISTURBANCES. PATIENT PRESENTED WITH RESTRICTED RANGE OF MOTION, MUSCLE IMBALANCES AND MUSCLE WEAKNESS AROUND HER CERVICAL SPINE. ON (B)(6) 2012 PATIENT UNDERWENT CT LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: NO DEFINITE CHANGES FROM (B)(6) 2012. FUSION AND LAM INECTOMY WITHOUT DEFINITE SPACE OCCUPYING HEMATOMA; HARDWARE AND FUSION AS DESCRIBED. STABLE MEDIAL PLACEMENT OF RIGHT L5 AND S1PEDICLE SCREWS. PLEASE SEE OF ABOVE AND PRIOR REPORT FOR A DETAILED DESCRIPTION. STABLE POSSIBLE L3-L4 RIGHT PARACENTRAL DISC HERNIATION VERSUS SCARRING; IMAGING OF THE CENTRAL CANAL BY NONCONTRAST CT IS LIMITED AND SIGNIFICANT ABNORMALITIES MAY BE MISSED. ON (B)(6) 2012 PATIENT PRESENTED WITH INCREASING LOWER BACK PAIN. DOCTOR RECOMMENDED MUSCLE RELAXANT AND ANTI INFLAMMATORY MEDICINES. ON (B)(6) 2012 PATIENT UNDERWENT CT FOR CHEST. IMPRESSION: SMALL RIGHT UPPER LOBE PULMONARY NODULES; MILD DIFFUSE EMPHYSEMATOUS CHANGES; STATUS POST CHOLECYSTECTOMY WITH PROBABLE INCREASED CAPACITY DILATION OF THE COMMON BILE DUCT; OTHERWISE REMARKABLE. ON (B)(6) 2012 PATIENT PRESENTED WITH CT OF CHEST WHICH SHOWED SMALL RIGHT UPPER LOBE PULMONARY NODULES. THERE WERE DIFFUSE EMPHYSEMATOUS CHANGES. ON (B)(6) 2012 PATIENT PRESENTED WITH INCREASING PAIN IN HER NECK, ACROSS HER SHOULDERS AND DOWN INTO HER ARMS. DOCTOR¿S IMPRESSION WAS CERVICAL SPINAL STENOSIS. ON (B)(6) 2013 PATIENT PRESENTED WITH PAIN IN NECK THAT DIFFUSELY RADIATED ACROSS SHOULDER SUBSEQUENTLY DOWN INTO HER ARMS. DOCTOR¿S IMPRESSION WAS CERVICAL SPINAL STENOSIS. ON (B)(6) 2013 PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF: DISC OSTEOPHYTE COMPLEX C4-5, C5-6, C6-7; CERVICAL RADICULOPATHY; AXIAL NECK PAIN. PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION C4-5, C5-6, C6-7 WITH ALLOGRAFT BONE INSTRUMENTATION. NO PATIENT COMPLICATIONS ARE NOTED. PATIENT UNDERWENT X-RAY FOR SPINE TO CHECK FRACTURE OR LEVEL OF SURGERY WHICH SHOW TIP OF METALLIC INSTRUMENT AT THE LEVEL OF THE C5-C6 DISC SPACE. PATIENT UNDERWENT X-RAY FOR SPINE TO CHECK FRACTURE OR LEVEL OF SURGERY WHICH SHOW METALLIC PROBE SUPERIMPOSED ON THE ANTERIOR ASPECT OF THE C4-C5 DISC SPACE. PATIENT AGAIN UNDERWENT X-RAY OF SPINE WHICH SHOWS SATISFACTORY POSTOP APPEARANCE OF ANTERIOR SCREW-PLATE FUSION. ON (B)(6) 2013 PATIENT PRESENTED FOR FIRST POSTOPERATIVE VISIT. ON (B)(6) 2013 PATIENT PRESENTED FOR FOLLOW UP. PATIENT UNDERWENT X-RAY WHICH SHOWS THE HARDWARE TO BE IN PLACE AND INTACT AND THE FUSION TO BE CONSOLIDATING WELL. ON (B)(6) 2013 PATIENT PRESENTED FOR FOLLOW UP OF ANTERIOR CERVICAL DISCECTOMY AND FUSION. DOCTOR¿S ASSESSMENT WAS THAT OVERALL PATIENT IS DOING WELL WITH SOME PERSISTENT LEFT SHOULDER PAIN. ON (B)(6) 2013 PATIENT UNDERWENT MRI OF LEFT SHOULDER DUE TO PAIN IN SHOULDER JOINT. IMPRESSION: RELATIVELY MILD CUFF DISEASE, NO HIGH GRADE PARTIAL OR FULL THICKNESS CUFF TEAR; AC ARTHROPATHY. ON (B)(6) 2013 PATIENT PRESENTED FOR FOLLOW UP. PATIENT HAD AN MRI OD SHOULDER WHICH SHOW DEGENERATIVE CHANGES. ON (B)(6) 2013 PATIENT UNDERWENT MRI CERVICAL SPINE DUE TO NECK PAIN. IMPRESSION: POST SURGICAL CHANGES OF C4-C7 ACDF WITH NO SIGNIFICANT EXIT FORAMINAL STENOSIS AT ANY LEVEL. A LEFT PARACENTRAL OSTEOPHYTE AT C5-C6. A LOW SIGNAL LEFT PARACENTRAL STRUCTURE AT LEVEL C5 LIKELY REPRESENTS A SCREW PROTRUDING INTO THE CENTRAL CANAL. AN OSTEOPHYTE IS CONSIDERED LESS LIKELY GIVEN THE DEGREE OF SUSCEPTIBILITY ARTIFACT. IF EVALUATION OF HARDWARE POSITIONING IS CLINICALLY INDICATED, CT IS THE EXAMINATION OF CHOICE. ON (B)(6) 2013 PATIENT PRESENTED WITH NECK PAIN. PATIENT UNDERWENT MRI OF CERVICAL SPINE WHICH SHOWS EVIDENCE AT C4-C5 OF SOME MILD CENTRAL STENOSIS. AT C5-C6 THERE IS A DISC OSTEOPHYTE COMPLEX RESULTING IN SOME MILD STENOSIS AS WELL. DOCTOR¿S RECOMMENDATION WAS SELECTIVE NERVE ROOT BLOCK AT C5-C6. ON (B)(6) 2013 PATIENT PRESENTED WITH CONTINUED NECK AND BACK PAIN.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH COMPLICATION OF URINARY FREQUENCY. IMPRESSIONS: PATIENT WITH EPIGASTRIC DISCOMFORT AND PREVIOUS HISTORY OF ANTRAL GASTRITIS. SHE AS WEARING A CONSTRICTIVE BACK BRACE GIRDLE TYPE APPARATUS THAT MAY BE CAUSING SOME INTRAABDOMINAL PRESSURE AND EXACERBATING HER REFLUX ALTHOUGH HER REFLUX SYMPTOMS ARE PREDOMINATELY THE FIRST THING IN THE MORNING AND SEEM TO BE NOCTURNAL. THIS APPARATUS MAY ALSO HAVE SOME EFFECT ON HER URINARY FREQUENCY WHICH SEEMS TO BE ONLY DURING THE DAY. UA WAS NEGATIVE FOR ANY SIGN OF INFECTION. ON (B)(6) 2008, THE PATIENT WAS PRESENTED FOR OFFICE VISIT FOR A PERIODIC ASSESSMENT OF HER CHRONIC MEDICAL CONDITIONS. IMPRESSIONS: LEFT L5 SCIATICA, HYPERLIPIDEMIA, INSOMNIA, HYPOTHYROIDISM, ALLERGIC RHINITIS, RESTLESS LEG SYNDROME, COPD, GERD, OSTEOARTHRITIS. ON (B)(6) 2001, PATIENT PRESENTED WITH COMPLAINT OF LOWER CHEST DISCOMFORT. ON (B)(6) 2001, THE PATIENT PRESENTED WITH POST NASAL DRAINAGE AND RHINORRHEA. ON (B)(6) 2001, THE PATIENT PRESENTED IN THE FACILITY. ON (B)(6) 2001, THE PATIENT PRESENTED WITH LOW BACK AND BILATERAL LEG PAIN. THE PAIN IS IN THE BACK RADIATING TO BOTH BUTTOCKS DOWN THE LATERAL ASPECT OF BOTH THIGHS AND CALVES TO THE ANKLES. ON (B)(6) 2001, THE PATIENT PRESENTED FOR A FOLLOW UP. HER MRI SHOWED SIMILAR FINDINGS TO THE ONE IN 1999 WITH SIGNIFICANT END PLATE EDEMA AT L5 AND DEGENERATIVE DISC AT L4 AND L5. ON (B)(6) 2001, THE PATIENT PRESENTED WITH INTRACTABLE LOW BACK AND BILATERAL LEG PAIN AND WAS DIAGNOSED WITH LUMBAR DEGENERATIVE DISC DISEASE, PROBABLE L4-5. PROVOCATIVE DISCOGRAPHY WAS PERFORMED AT L2-3, L3-4 AND L4-5. ON (B)(6) 2002, THE PATIENT PRESENTED FOR A FOLLOW UP POST HER DISCOGRAM. HER MRI SHOWED SIGNIFICANT DEGENERATION OF L5 ON (B)(6) 2002, PATIENT COMPLAINS OF SHOOTING PAIN IN HER LEFT LOWER EXTREMITY WHICH RADIATES INTO THE LEFT POSTERIOR THIGH AND INTO THE CALF WITH NUMBNESS AND TINGLING IN THE SAME DISTRIBUTION. SHE DOES HAVE WEAKNESS OF THE LEFT LOWER EXTREMITY. SHE HAS PAIN AT NIGHT WHICH AWAKENS HER. SHE DOES HAVE INCREASING PAIN WITH AMBULATION INCREASING PAIN WITH ACTIVITIES. REVIEW OF SYSTEMS: PATIENT REPORTS HAVING DECREASED CIRCULATION OF THE EXTREMITIES AND ARTHRITIS. EXAMINATION: MUSCULOSKELETAL: PATIENT WAS NOTED TO HAVE TENDERNESS TO PALPATION IN THE MIDLINE FROM APPROXIMATELY L3 TO S1 WITH MIDLINE TENDERNESS BEING GREATER THAN PARA-SPINAL TENDERNESS. NEUROLOGICAL: MOOD WAS DEPRESSED. SHE DID HAVE AN ANTALGIC GAIT. PATIENT WAS ABLE TO TOE WALK BUT UNABLE TO HEEL WALK . MRI OF LUMBAR SPINE WAS REVIEWED WHICH REVEALED EVIDENCE OF DEGENERATIVE DISK DISEASE AT L4-5 AND L5-S1. REPORT FROM HER DISKOGRAM REVEALED CONCORDANT PAIN AT L4-5. ON (B)(6) 2002, THE PATIENT PRESENTED WITH BACK PAIN. A COMPARATIVE STUDY WAS DONE. IMPRESSION: STATUS POST POSTERIOR FUSION OF L4 THROUGH S1 WITH NO EVIDENCE OF COMPLICATION AND NO EVIDENCE OF INSTABILITY. ON (B)(6) 2002, THE PATIENT PRESENTED FOR A FOLLOW UP VISIT. HER LUMBAR SPINE X-RAYS SHOWED A STABLE FUSION CONSTRUCTS ON (B)(6) 2002, THE PATIENT PRESENTED WITH COMPLAINT OF NAUSEA DUE TO HER MEDICINE. ON (B)(6) 2002, PATIENT PRESENTED FOR FOLLOW UP TO BRONCHITIS. ON (B)(6) 2003, THE PATIENT PRESENTED FOR A FOLLOW UP FROM HER MRI SCAN OF THE LUMBAR SPINE. SHE WAS STILL BOTHERED WITH LOW BACK PAIN. THE STUDY SHOWS NORMAL POST-OPERATIVE CHANGES WITHOUT ANY SIGNIFICANT NEW NEURAL COMPROMISE OR OTHER STRUCTURAL ABNORMALITY. ON (B)(6) 2003 , THE PATIENT PRESENTED WITH CHEST PAIN , COUGH. ON (B)(6) 2003, THE PATIENT PRESENTED WITH COMPLAINT OF LOW BACK PAIN , LOWER LEFT EXTREMITY RADICULOPATHY , FAILED BACK SYNDROME. ON (B)(6) 2003, PER OP NOTES, PATIENT PRESENTED FOR ROUTINE FOLLOW UP ,EVALUATION AND MEDICINE REFILL. ON (B)(6) 2004, THE PATIENT AGAIN VISITED THE FACILITY AND UNDERWENT XRAYS ON (B)(6) 2008, PATIENT PRESENTED FOR MEDICINE REFILL AND FOLLOW UP , NERVE CONDUCTION STUDY/ TESTING (B)(6) 2008, PATIENT PRESENTED FOR OFFICE VISIT AND REPORTED THAT SHE WAS MOVING SOME BOXES INTO STORAGE ON (B)(6) 2007 AND STARTED HAVING A LOT OF PAIN IN HER BACK WHICH SUBSEQUENTLY RADIATED DOWN THE LEFT LEG. ON (B)(6) 2008, THE PATIENT UNDERWENT MRI OF LUMBAR SPINE. ON (B)(6) 2008, THE PATIENT PRESENTED FOR FOLLOW UP AND DISCUSSION ON MEDICAL CONDITION. ON (B)(6) 2008, THE PATIENT HAD ROH PSF DECOMP L3/S1 PROCEDURE. ON (B)(6) 2008, THE PATIENT PRESENTED FOR PRE SURGICAL CONFERENCE. RISK OF PROCEDURE AND OTHER THINGS WERE EDUCATED TO PATIENT. ON (B)(6) 2008: PATIENT PRESENTED FOR OFFICE VISIT WITH PRIMARY DIAGNOSIS OF DEGENERATIVE DISC DISEASE, LOW BACK PAIN, SPINAL STENOSIS, RADICULOPATHY. PATIENT CALLED AND COMPLAINED OF PAIN IN HIP AND DOWN LEG. ON (B)(6) 2008: PATIENT CALLED AND COMPLAINS OF LOW BACK AND HIP. ON (B)(6) 2008: PATIENT CALLED AND REPORTED THAT WHENEVER SHE TURNS OR TRIES TO GET INTO/OUT OF BED IT FEELS LIKE HER HIP IS GOING TO LOCK UP. 13 OCT 2001: PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. IMPRESSION: MILD DEGENERATIVE CHANGES AT L4-5 AND L5-S1 WITHOUT HIGH GRADE CENTRAL OR FORAMINAL ENCROACHMENT. ON (B)(6) 2001, (B)(6) 2002, (B)(6) 2003: PATIENT PRESENTED FOR AN OFFICE VISIT. 21 JAN 2002: PATIENT PRESENTED WITH LOW BACK AND LEG PAIN. MRI OF THE LUMBAR SPINE REVEALS EVIDENCE OF DEGENERATIVE DISK DISEASE AT L4-5 AND L5-S1. ON (B)(6) 2002: PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: LUMBAR RADICULOPATHY, LUMBAR DISC DISEASE. PROCEDURE: TOTAL LAMINECTOMY, L4, L5, FORAMINOTOMIES OF L4, L5 AND S1 NERVE ROOTS BILATERALLY. ILIAC BONE GRAFT HARVESTING(POSTERIOR LEFT), POSTERIOR LUMBAR INTERBODY FUSION, L4 TO L5 AND L5 TO S1 WITH A TOTAL OF FOUR¿¿¿¿ARTHRODESIS OF L4 TO L5 AND L5 TO S1 WITH INTERFACET BONE GRAFT, PEDICLE SCREWS FIXATION, L4 TO L5 TO S1 WITH TWO 7 X 30MM TITANIUM SCREWS IN L4, TWO 7X40 MM TITANIUM SCREWS IN L5 AND TWO 7 X 30MM TITANIUM SCREWS IN S1. INTRAOPERATIVE FLUOROSCOPY. TOTAL DISKECTOMIES OF L4-5 AND L5-S1. ON (B)(6) 2002: PATIENT PRESENTED WITH LOW BACK PAIN AND LEFT LEG PAIN. IMPRESSION: LUMBAR DEGENERATIVE DISK DISEASE, STATUS POST LUMBAR FUSION. ON (B)(6) 2002: PATIENT UNDERWENT X-RAY OF THE LUMBAR SPINE. PATIENT PRESENTED WITH BACK PAIN. IMPRESSION: STATUS POST POSTERIOR FUSION OF L4 THROUGH S1 WITH NO EVIDENCE OF COMPLICATION AND NO EVIDENCE OF INSTABILITY. ON (B)(6) 2003: PATIENT UNDERWENT X-RAY OF THE LUMBAR .IMPRESSION: POST SURGICAL CHANGES WITHOUT ABNORMAL MOTION WITH FLEXION OR EXTENSION. ON (B)(6) 2003: PATIENT PRESENTED WITH LOW BACK PAIN, LEFT LOWER EXTREMITY RADICULOPATHY, FAILED BACK SYNDROME. ON (B)(6) 2003: PATIENT PRESENTED WITH LUMBAR RADICULOPATHY, LUMBAR PAIN. ON (B)(6) 2004: PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2004: PATIENT PRESENTED FOR FOLLOW-UP. (B)(6) 2004: PATIENT UNDERWENT X-RAY OF THE LUMBAR SPINE. IMPRESSION: STATUS POST POSTERIOR FUSION FROM L4 TO S1 WITHOUT EVIDENCE OF COMPLICATION. SATISFACTORY DECOMPRESSION OF CENTRAL CANAL. MILD DEGENERATIVE CHANGES OF THE FUSION AT L3-4 AND L2-3 WITHOUT FOCAL DISK ABNORMALITY OR SIGNIFICANT CENTRAL CANAL STENOSIS. NO DYNAMIC INSTABILITY WITH FLEXION AND EXTENSION. ON (B)(6) 2004: PATIENT PRESENTED WITH STATUS POST FUSION BACK PAIN. ON (B)(6) 2008: PATIENT PRESENTED WITH LOWER BACK PAIN THAT RADIATES DOWN HER LEFT LEG. IMPRESSION: LEFT SCIATICA L5 RADICULOPATHY, SINUSITIS, RESTLESS LEG SYNDROME, COPD, HYPOTHYROIDISM. ON (B)(6) 2008: PATIENT UNDERWENT MRI LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: L4 THROUGH S1 POSTERIOR FUSION WITH DISC INTERPOSITION BUT NO FINDINGS OF RECURRENT DISC, HARDWARE FAILURE OR SIGNIFICANT STENOSIS. ON (B)(6) 2008: PATIENT PRESENTED FOR FOLLOW-UP. PATIENT HAS TENDERNESS TO PALPATION IN THE MIDLINE AREA, AT L4-L5, AT L5-S1. ON (B)(6) 2008: PATIENT UNDERWENT X-RAY OF LUMBAR SPINE. IMPRESSION: STATUS POST LUMBAR SPINE FUSION FROM L4 THROUGH S1 WITHOUT FINDINGS TO SUGGEST HARDWARE LOOSENING OR HARDWARE FAILURE. MILD CENTRAL CANAL STENOSIS AT L3-L4 WITH CUT OFF OF NORMAL FILLING OF THE L3 NERVE ROOT SLEEVES BILATERALLY. MILD ¿MODERATE CENTRAL CANAL STENOSIS AT L2-L3. PATIENT UNDERWENT CT SCAN OF LUMBAR SPINE. IMPRESSION: STATUS POST LUMBAR SPINE FUSION FROM L4 THROUGH S1 WITHOUT FINDINGS TO SUGGEST HARDWARE LOOSENING OR HARDWARE FAILURE. STABLE APPEARANCE OF THE CENTRAL CANAL AND FORAMINA AT THE LEVEL OF FUSION. PROGRESSION OF MILD DEGENERATIVE CHANGES AT L2-L3 AND L3-L4 AS DESCRIBED. AT L2-L3, THERE IS A MILD CENTRAL CANAL STENOSIS WHICH HAS SLIGHTLY WORSENED WHEN COMPARED WITH THE PRIOR STUDY. AT L3-4 THERE IS A MILD BILATERAL FORAMINAL STENOSIS AND MINIMAL CENTRAL CANAL STENOSIS WHICH HAS PROGRESSED SLIGHTLY WHEN COMPARED TO PRIOR STUDY. ON (B)(6) 2008: PATIENT PRESENTED WITH PAIN IN HER BACK RADIATING DOWN THE LEFT LEG. IMPRESSION: L3-4 LUMBAR DEGENERATIVE DISK DISEASE WITH STENOSIS. PATIENT PRESENTED WITH THE FOLLOWING DIAGNOSIS: LUMBAR SPINAL STENOSIS. DEGENERATIVE DISK DISEASE, LUMBAR RADICULOPATHY, MECHANICAL LOW BACK PAIN. OPERATION: REMOVAL OF SEGMENTAL HARDWARE AT L4-S1. EXPLORATION OF FUSION. REVISION OF L4, COMPLETE L3, PARTIAL L2, LAMINECTOMY, PARTIAL FACETECTOMY AND BILATERAL FORAMINOTOMIES. POSTERIOR INSTRUMENTED FUSION L2 TO L4 WITH RH-BMP2/ACS LOCAL ALLOGRAFT BONE AND DEMINERALIZED BONE MATRIX. PER OP NOTES: THE FACET JOINTS WERE DECORTICATED AND TRANSVERSE PROCESS BILATERALLY FROM L2 TO L4, AND SUBSEQUENTLY PROCEEDED WITH PLACEMENT OF OUR BONE GRAFT WHICH CONSISTED OF RH-BMP2/ACS LOCAL ALLOGRAFT BONE AND DEMINERALIZED BONE MATRIX. THIS WAS PACKED INTO THE LATERAL GUTTERS AS WELL AS INTO THE DECORTICATED FACET JOINTS. PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2008: PATIENT PRESENTED FOR FOLLOW UP. PATIENT UNDERWENT X-RAY WHICH REVEALS POSTERIOR PEDICLE SCREW INSTRUMENTATION L2 TO L4 AND PREVIOUS FUSION AT L4-5 AND L5-S1. NO EVIDENCE OF HARDWARE FAILURE. ON (B)(6) 2008, (B)(6) 2012: PATIENT PRESENTED FOR FOLLOW-UP. ON (B)(6) 1997, (B)(6) 1999, THE PATIENT PRESENTED FOR RADIOLOGY EXAMINATION. ON (B)(6) 2003, THE PATIENT UNDERWENT MRI -LUMBAR SPINE. ON (B)(6) 2003, THE PATIENT PRESENTED FOR RADIOLOGY EXAMINATION ¿ DEXA BONE DENSITY. ON (B)(6) 2003, THE PATIENT PRESENTED FOR OPHTHALMIC DIAGNOSTIC. ON (B)(6) 2005, THE PATIENT PRESENTED FOR ULTRASOUND OF SOFT TISSUE OF HEAD/NECK. ON (B)(6) 2005 , THE PATIENT UNDERWENT MRI HIPS. 12 DEC 07, THE PATIENT UNDERWENT SOME TREATMENT. ON (B)(6) 2007, THE PATIENT APPEARED FOR PATHOLOGICAL EXAMINATION /EVALUATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2004 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH TWISTED LEFT ANKLE DUE TO FALL. IMPRESSIONS: 1) CHRONIC BACK PAIN SECONDARY TO DEGENERATIVE DISC DISEASE. 2) LOWER EXTREMITY CRAMPING. NO COMPLICATION WAS REPORTED WRT HER LEFT ANKLE. ON (B)(6) 2004 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH SEVERE LOW BACK PAIN WITH NUMBNESS OF LEFT LEG. IMPRESSIONS: 1) CHRONIC BACK PAIN/DISC DISEASE WITH NERVE IMPINGEMENT, 2) THYROMEGALY/GOITER, 3) VERTIGO. ON (B)(6) 2004 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH SEVERE BACK PAIN. IMPRESSIONS: OSTEOPENIA ON (B)(6) 2005 THE PATIENT WAS PRESENTED FOR THE OFFICE VISIT WITH THYROIDECTOMY. MEDICATIONS REVIEWED. ON (B)(6) 2005 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH 1) COUGH AND WHEEZING, 2) FATIGUE ALL THE TIME, 3) RESTLESS LEG HAD WORSENED. IMPRESSIONS: 1) BRONCHITIS, 2) MALAISE AND FATIGUE, 3) SUPRAPUBIC ABDOMINAL PAIN. ON (B)(6) 2005 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH CRAMPS IN HER BILATERAL LOWER EXTREMITIES AND RESTLESS LEG SYNDROME WORSENED. MEDICATIONS REVIEWED. ON (B)(6) 2005 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH DIZZINESS. IMPRESSIONS: 1) SINUSITIS, 2) LEFT PERITRACHEAL MASS, 3) P OLYCURIA. ON (B)(6) 2005 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH MATTING OF BILATERAL EYES WITH THICK YELLOW MUCUS. ON (B)(6) 2005 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH SEVERE TOOTH PAIN, FATIGUE AND WEAKNESS. ALSO HAD SOME SEVERE PAIN IN RIGHT HIP. IMPRESSIONS: 1) ACUTE SINUSITIS, 2) MULTIPLE CAROUS TOOTH WITH GINGIVITIS. ON (B)(6) 2005 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH CONTINUED HIP PAIN AND REFILL OF HER MEDICINE. IMPRESSIONS: 1) LEFT HIP PAIN, 2) LUMBAGO, 3) HYPOTHYROIDISM. ON (B)(6) 2006 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH CHEST PAIN, GREEN SPUTUM PRODUCTION AND SEVERE COUGH. IMPRESSIONS: 1) ACUTE BRONCHITIS, 2) LUMBAGO, 3) HYPOTHYROIDISM, 4) OSTEOARTHRITIS OF THE HIP. ON (B)(6) 2006 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH WEAKNESS IN HER LEGS, LEFT SIDED CHEST PAIN WITH RADIATION DOWN HER LEFT ARM AND NUMBNESS. IMPRESSIONS: 1) LEG WEAKNESS, 2) HYPERLIPIDEMIA, 3) DEPRESSION, 4) HYPOTHYROIDISM. ON (B)(6) 2006 THE PATIENT WAS PRESENTED FOR OFFICE VISIT FOR FOLLOW UP. IMPRESSIONS: 1) LEG WEAKNESS, 2) HYPERLIPIDEMIA, 3) DEPRESSION, 4) HYPOTHYROIDISM. ON (B)(6) 2006 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH TINGLING IN FEET AND NUMBNESS. IMPRESSIONS: BILATERAL PNEUMONIA; 1) LEG WEAKNESS, 2) HYPERLIPIDEMIA, 3) DEPRESSION, 4) HYPOTHYROIDISM. ON (B)(6) 2006 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH DIZZINESS, CRAMPING, NAUSEA, VOMITING AND DIARRHEA. 1) ACUTE GASTROENTERITIS, 2) DEHYDRATION, 3) HYPOTHYROIDISM, 4) HYPERLIPIDEMIA. ON (B)(6) 2006, THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH DIZZINESS, FATIGUE AND WEAKNESS. 1) LEG WEAKNESS, 2) HYPERLIPIDEMIA, 3) DEPRESSION, 4) HYPOTHYROIDISM, 5) RESTLESS LEG SYNDROME, 6) GERD, 7) COPD, 8) PVD. ON (B)(6) 2006, THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH EXACERBATION IN HER COPD. IMPRESSIONS: 1) LEG WEAKNESS, 2) HYPERLIPIDEMIA, 3) DEPRESSION, 4) HYPOTHYROIDISM, 5) RESTLESS LEG SYNDROME, 6) GERD, 7) COPD, 8) PVD, 9) CHEILOSIS, 10) PERIPHERAL NEUROPATHY, 11) ALLERGIC RHINITIS.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2004 PATIENT UNDERWENT X-RAY OF CHEST. IMPRESSION: NO EVIDENCE OF ACTIVE PULMONARY DISEASE. (B)(6) 2007 THE PATIENT UNDERWENT X-RAY OF THE RIGHT ANKLE DUE TO INJURY. IMPRESSION: NEGATIVE EXAM. (B)(6) 2007 THE PATIENT UNDERWENT X-RAY OF THE RIGHT FOOT DUE TO INJURY. IMPRESSION: DISTAL THIRD AND FOURTH METATARSAL FRACTURES. (B)(6) 2008 PATIENT UNDERWENT X-RAY OF CHEST. IMPRESSION: NEGATIVE CHEST AND STABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINE FUSION SURGERY ON THE LUMBAR REGION OF HER SPINE FROM L2 TO L4 USING RHBMP-2/ACS. IT WAS REPORTED THAT THE PATIENT'S POST-OPERATIVE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE BACK PAIN THAT RADIATES INTO HER LOWER EXTREMITIES. ON (B)(6) 2008 THE PATIENT UNDERWENT A REVISION SURGERY. IT WAS REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE SEVERE BACK PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
40307 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