INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-00977
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- August 14, 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). 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.
REVIEW OF RADIOGRAPHIC IMAGES FOUND AS FOLLOWS: (B)(6) 2006 L SPINE X RAY AP/LATERAL DISC SPACE COLLAPSE L5-S1 (B)(6) 2006 L SPINE X RAY AP/LATERAL POST OP L5-S1 FUSION SATISFACTORY HARDWARE PLACEMENT, INTERBODY GRAFT PRESENT (B)(6) 2006 L SPINE X RAY AP/LATERAL POST OP L5-S1 FUSION EARLY BONY FORAMATION IN INTERBODY SPACE. NO OTHER CHANGE (B)(6) 2006 L SPINE X-RAY NO CHANGE (B)(6) 2006 L SPINE X RAY AP/LATERAL NO CHANGE (B)(6) 2006 L SPINE X-RAY POST OP FROM REVISION OF FUSION WITH EXTENSION TO L4-5. ADEQUATE HARDWARE PLACEMENT. INTERBODY GRAFT PRESENT AT L4-5 2/27/2007 L SPINE X-RAY NO CHANGE, FORAMEN APPEAR PATENT (B)(6) 2007 L SPINE X-RAY AP/LATERAL NO CHANGE (B)(6) 2007 L SPINE X-RAY AP/LATERAL NO CHANGE, FORAMENAL APPEARANCE OBSCURED BY BOWEL GAS PATTERN ON (B)(6) 2009 L SPINE X-RAY AP NO CHANGE (B)(6) 2009 L SPINE X-RAY AP/LATERAL BONY FORAMINAL STENOSIS PRESENT AT L4-5 (B)(6) 2009 L SPINE XRAY LATERAL BONY FORAMINAL STENOSIS PRESENT AT L4-5 (B)(6) 2009 L SPINE X RAY LATERAL SOLID FUSION L5-S1 INTERBODY SPACE, BONY STENOSIS L4-5 (B)(6) 2009 L SPINE X RAY AP NO CHANGE (B)(6) 2009 L SPINE X RAY AP NO CHANGE (B)(6) 2009 L SPINE X RAY AP NO CHANGE (B)(6) 2009 L SPINE X RAY LATERAL BONY FORAMINAL STENOSIS L4-5, SOLID FUSION PRESENT L4-5, L5-S1 (B)(6) 2009 L SPINE X RAY AP HARDWARE REMOVED, SOLID POSTEROLATERAL FUSION MASS L5-S1 (B)(6) 2009 L SPINE X RAY LATERAL HARDWARE REMOVED, APPEARS TO HAVE DECOMPRESSION OF L4-5 FORAMEN (B)(6) 2010 L SPINE X RAY LATERAL PROGRESSIVE BONY FORMATION L4-5 INTERBODY SPACE (B)(6) 2010 L SPINE X RAY AP NO CHANGE (B)(6) 2014 C SPINE X RAY LATERAL POST OP C 5-6, C6-7 ACDF. HARDWARE PLACEMENT IS SATISFACTORY (B)(6) 2014 C SPINE X RAY AP AS ABOVE (B)(6) 2014 C SPINE X RAY AP NO CHANGE (B)(6) 2014 C SPINE X RAY LATERAL STABLE HARDWARE POSITION, FUSION NOT PRESENT (B)(6) 2014 C SPINE X RAY LATERAL SOME EARLY BONY FORMATION C5-6 (B)(6) 2014 C SPINE X RAY AP NO CHANGE (B)(6) 2014 C SPINE X RAY LATERAL NO CHANGE (B)(6) 2014 C SPINE X RAY AP NO CHANGE (B)(6) 2015 C SPINE X RAY AP/LATERAL APPEARS FUSION IS PRESENT C 5-6, C 6-7 IMPRESSION: PATIENT IS S/P L5-S1 INTERBODY FUSION IN 2006, AND REVISED TO L4-S1 SIX MONTHS LATER BY REPORT. UNCLEAR IF BMP WAS USED IN THE INITIAL PROCEDURE AT L5-S1, BUT REPORTED TO HAVE PLACEMENT OF RH-BMP-2 AT L4-5 REVISION. UNCLEAR IF USE WAS CONFINED TO THE INTERBODY SPACE OR IF THIS WAS ALSO USED FOR LATERAL AUGMENTATION. EXUBERANT BONY GROWTH IS PRESENT ON SERIAL X RAY IMAGING WITH PROGRESSIVE FORAMINAL STENOSIS AT L4-5 EVENTUALLY LEADING TO REVISION OF BONE GRAFT AND REMOVAL OF HARDWARE. DUROTOMY RESULTING IN CSF LEAK IS A COMPLICATION OF THIS THIRD PROCEDURE. EVENTUALLY THE PATIENT ALSO UNDERWENT A CERVICAL DECOMPRESSION AND FUSION. ROOT CAUSE: SURGICAL TECHNIQUE.
ADD'L INFO.
ADD'L INFO: (B)(4).
REVIEW OF RADIOGRAPHIC IMAGES FOUND AS FOLLOWS: (B)(6) 2004 LUMBAR SPINE SERIES AP, LATERAL, OBLIQUES AND L5 SPOT ALL APPEAR NORMAL. (B)(6) 2006 LUMBAR MRI T2 SAGITTAL VIEWS SHOW DESICCATION OF THE L4 AND L5 DISC SPACES. HIZ (HYPERINTENSE ZONE) SUGGESTIVE OF ANNULAR TEAR PRESENT MIDLINE L4 WITH FLATTENING, SCLEROSIS AND DISC PROTRUSION AT L5. CONUS IS BEHIND L1 AND APPEARS NORMAL. NO SIGNIFICANT STENOSIS IS SEEN. MODERATE CENTRAL TO LEFT PARACENTRAL HNP IS SEEN AT L5 PROTRUDING INTO THE CANAL JUST MEDIAL TO THE TRANSITIONING S1 ROOT. HIZ CAN BE SEEN IN MIDLINE AND REPRESENTS A PERIPHERAL CIRCUMFERENTIAL RADIAL TEAR OF THE ANNULUS. (B)(6) 2008 DIGITAL MAMMOGRAM NO COMMENT (B)(6) 2011 CERVICAL SPINE SERIES SHOWS OVERALL GOOD MOBILITY ON DYNAMIC STUDIES. SLIGHT DISC SPACE NARROWING AND FLATTENING OF THE KYPHOSIS IS SEEN FROM C3 TO C6. NO FRACTURES, INSTABILITY IS NOTED. (B)(6) 2013 CERVICAL MRI T2 AXIALS SHOW FLATTENING OF THE CERVICAL LORDOSIS, DISC FLATTENING AT ALL LEVELS AND BULGING AT C3/4 AND C6/7. CORD AND CANAL ARE NOT AFFECTED. AXIALS SHOW UNCOVERTEBRAL HYPERTROPHY THAT FLATTENS THE VENTRAL SUBARACHNOID SPACE SLIGHTLY ON THE LEFT. CENTRAL HNP NARROWS THE CANAL AT C6/7 NARROWING THE SUBARACHNOID SPACE SLIGHTLY. (B)(6) 2013 SHOULDER SERIES 4 VIEWS TWO PA, AN AXILLARY LATERAL AND A SCAPULAR ¿Y¿ VIEW OF THE RIGHT SHOULDER ARE VIEWED AND APPEAR NORMAL. A PORTION OF THE LOWER CERVICAL AND UPPER THORACIC SPINE CAN BE SEEN AND APPEAR NORMAL. NO OTHER SPINAL IMAGING IS PROVIDED ON THIS PATIENT.
(B)(4).
THE FOLLOWING IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. (B)(6) 2006 LUMBAR MRI. SAGITTAL VIEWS SHOW HIZ (HYPERINTENSE ZONE) CONSISTENT WITH POSTERIOR ANNULAR TEAR AT L4. DESICCATION OF L4 AND L5 WITH HNP NOTED CENTRALLY AT L5. MODIC II CHANGES ARE NOTED IN THE ENDPLATES ON EITHER SIDE OF THE L5 DISC ANTERIORLY. AXIAL VIEWS SHOW THE L5 DISC TO BE CENTRAL AND SLIGHTLY LEFT PARACENTRAL. NO CENTRAL OR FORAMINAL STENOSIS IS NOTED. NO EVIDENCE OF ANY SURGERY IS NOTED.
IT WAS REPORTED THAT PATIENT UNDERWENT A L4-L5 LAMINECTOMY AND DISCECTOMY AND MULTILEVEL POSTERIOR INTERBODY FUSION FROM L4-S1. SURGEON UTILIZED RHBMP-2/ACS WITH ALLOGRAFT AND PLACED THE MIXTURE INSIDE A HOLLYWOOD CAGE. ON (B)(6) 2009, PATIENT WAS DIAGNOSED WITH BONY OVERGROWTH, FORAMINAL STENOSIS, LUMBAR RADICULOPATHY, AND OTHER BODILY INJURIES AND RELATED SEQUELAE. PATIENT EXHIBITED CONTINUING BACK PAIN AND RADICULOPATHIES AND OTHER RELATED SEQUELAE. AS A RESULT, PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT, INCLUDING HAVING TO UNDERGO AN ADDITIONAL SPINE SURGERY ON (B)(6) 2009 TO TREAT HER INJURIES AND RELATED SEQUELAE. PATIENT HAS NEVER RECOVERED FROM HER SURGERY INVOLVING RHBMP-2/ACS AND CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM WORKING AND FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L4-5 DISC HERNIATION, DEGENERATION AND ANNULAR TEARING. THE PATIENT UNDERWENT L4-5 LAMINECTOMY, DISCECTOMY, AND EXTENSION OF FUSION FROM L5-S1 TO L4-5 USING LAGUNA PEDICLE SCREWS, HOLLYWOOD INTERBODY DEVICE, ALLOGRAFT, RHBMP-2/ACS, AND LOCAL BONE. PER THE SURGEON'S NOTES, THE PATIENT HAS A "LONG HISTORY OF BACK PROBLEMS, STATUS POST L5-S1 FUSION SIX MONTHS AGO WITH INITIALLY GOOD RESULTS, NOW WORSENING OF PAIN OVER THE LAST MONTH AFTER A FALL. MRI SCAN SHOWED DISC HERNIATION AND STENOSIS ON THE LEFT AT L4-L5 WITH ANNULAR TEARING AND DISC DEGENERATION AT L4-L5." AT 970 DAYS POST-OP, THE PATIENT PRESENTED WITH L4-5 STENOSIS AND RETAINED HARDWARE. THE PATIENT UNDERWENT HARDWARE REMOVAL L4-S1, EXPLORATION OF THE FUSION MASS, AND REVISION L4-5 LAMINECTOMY AND DECOMPRESSION. PER THE OPERATIVE NOTES, THE PATIENT HAS "HISTORY OF MULTIPLE PREVIOUS SURGERIES, NOW WITH RECURRENT LEG PAIN. IMAGING STUDIES INCLUDING X-RAYS, MRI, AND MYELOGRAM SHOWED SOME BONY STENOSIS AT L4-L5 ON THE LEFT DUE TO BONY OVERGROWTH WITH INTACT HARDWARE AND FUSION FROM L4-S1." DURING THE SURGERY, THE PHYSICIAN NOTED "THERE WAS BONY OVERGROWTH THAT WAS STUCK DOWN TO THE DURA. THIS WAS DEBRIDED. DURING THAT TIME, THERE WAS SOME ABRASION OF THE DURA. THIS WAS PATCHED WITH DURAGEN AND TISSEEL TO PREVENT ANY SPINAL FLUID LEAKAGE. ONCE THE PATCH AND SEALANT WERE APPLIED, THERE WAS NO EVIDENCE OF ANY CSF LEAKAGE." AT 11 DAYS POST-OP, THE PATIENT PRESENTED WITH A SPINAL HEADACHE AND CSF LEAK. THE PATIENT UNDERWENT A REVISION SURGERY CONSISTING OF WOUND EXPLORATION, DURAL REPAIR AND PATCH.
UPDATE NOTIFIED DATE (B)(6) 2015 IT WAS REPORTED ON : (B)(6) 2012: LYRICA MEDICATION WAS STARTED. ON (B)(6) 2014: PATIENT PRESENTED WITH CHIEF COMPLAINT OF NECK AND BACK PAIN. ASSESSMENT: CERVICAL DISC HERNIATION, S/P FUSION; LUMBAR SPONDYLOLISTHESIS, STENOSIS, DISC HERNIATION, S/P FUSION WITH CHRONIC RADICULOPATHY. THE PATIENT UNDERWENT X-RAY OF CERVICAL SPINE, AP LATERAL. FINDINGS: HER PREVIOUS HARDWARE AND FUSION TO WERE STABLE. ON (B)(6) 2014: PATIENT PRESENTED WITH FOLLOWING DIAGNOSIS: STATUS POST CERVICAL FUSION. ON (B)(6) 2014: PATIENT PRESENTED WITH CHIEF COMPLAINT OF NECK AND BACK PAIN. CERVICAL AND LUMBOSACRAL EXAM SHOWED PAIN WITH MOTION. THE PATIENT UNDERWENT X-RAY OF CERVICAL SPINE, AP LATERAL. FINDINGS: HER PREVIOUS HARDWARE AND FUSION TO WERE STABLE. ASSESSMENT: ASSESSED SPINAL STENOSIS OF CERVICAL REGION; ASSESSED DISPLACEMENT OF LUMBAR INTERVERTEBRAL DISC WITHOUT MYELOPATHY; CERVICAL AND LUMBAR DISC HERNIATION AND STENOSIS; CHRONIC RADICULOPATHY. ON (B)(6) 2015: THE PATIENT PRESENTED WITH NECK <(>&<)> BACK PAIN. HER SYMPTOMS WERE THE SAME WITH PAIN BOTH IN THE NECK AND BACK AND RESIDUAL PAIN IN THE NECK AND RIGHT SHOULDER. CERVICAL EXAM: PAIN ON MOTION OF THE RIGHT SHOULDER WITH IMPINGEMENT. LUMBOSACRAL EXAM: PAIN WITH MOTION. THE PATIENT UNDERWENT X-RAY OF CERVICAL SPINE, AP LATERAL. FINDINGS: THE HARDWARE WAS INTACT AND THE FUSION WAS STABLE. THERE WERE SLIGHT DEGENERATIVE CHANGES. ASSESSMENT: ASSESSED SPINAL STENOSIS OF CERVICAL REGION; ASSESSED DISPLACEMENT OF LUMBAR INTERVERTEBRAL DISC WITHOUT MYELOPATHY; CERVICAL AND LUMBAR DISC HERNIATION AND RADICULOPATHY; RIGHT SHOULDER IMPINGEMENT.
ON (B)(6) 2002: PER BILLING RECORDS, THE PATIENT UNDERWENT A TRANSVAGINAL AND PELVIS ULTRASOUND. 27 DEC 2010: THE PATIENT, PER BILLING RECORDS, PRESENTED IN ER WITH TORTICOLLIS AND HEADACHE. ON (B)(6) 2012: THE PATIENT, PER BILLING RECORDS, PRESENTED IN ER WITH THE DIAGNOSIS OF: FOREIGN BODY IN ESOPHAGUS. THE PATIENT UNDERWENT A SOFT TISSUE NECK CT. ON (B)(6) 2013: THE PATIENT, PER BILLING RECORDS, PRESENTED IN ER WITH THE DIAGNOSIS OF "OTHER SYMPTOMS INVOLVING HEAD AND NECK" AND "FOREIGN BODY IN ESOPHAGUS". THE PATIENT UNDERWENT A SOFT TISSUE NECK CT. ON (B)(6) 2013: THE PATIENT, PER BILLING RECORDS, PRESENTED IN ER WITH THE DIAGNOSIS OF: UNSPECIFIED SYMPTOM ASSOCIATED WITH FEMALE GENITAL ORGAN; URINARY TRACT INFECTION; ACUTE PYELONEPHRITIS WITHOUT LESION OF RENAL MEDULLARY; AND ABDOMINAL PAIN. ON (B)(6) 2003: THE PATIENT PRESENTED WITH CENTRAL ABDOMINAL PAIN. IMPRESSION: LOWER ABDOMINAL PAIN, TENDERNESS, LEUKOCYTOSIS AND FEVER. POSSIBLE APPENDICITIS AND GYNECOLOGIC INFECTION. THE PATIENT UNDERWENT X-RAYS OF THE ABDOMEN AND UPRIGHT CHEST COMPARED WITH THE STUDY FROM (B)(6) 2002 DUE TO ABDOMINAL PAIN. IMPRESSION: NEGATIVE CHEST AND ABDOMEN SERIES. ON (B)(6) 2003: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSES: ACUTE APPENDICITIS; ABDOMINAL PAIN; LEUKOCYTOSIS. THE PATIENT UNDERWENT LAPAROSCOPIC APPENDECTOMY. NO COMPLICATIONS WERE NOTED. THE PATIENT UNDERWENT CT SCAN OF THE ABDOMEN AND PELVIS FOR EVALUATION OF APPENDICITIS. IMPRESSION: FINDINGS WHICH COULD REPRESENT APPENDICITIS THOUGH THE APPENDIX CANNOT BE DEFINITIVELY IDENTIFIED. CORRELATION WITH CLINICAL PRESENTATION IS RECOMMENDED; MILDLY DILATED AND FLUID-FILLED COLON WITHOUT EVIDENCE FOR OBSTRUCTION OR FOCAL TRANSITION POINT; STATUS POST CHOLECYSTECTOMY WITH DILATED COMMON BILE DUCT.
IT WAS REPORTED THAT PATIENT UNDERWENT A L4-L5 LAMINECTOMY AND DISCECTOMY AND MULTILEVEL POSTERIOR INTERBODY FUSION FROM L4-S1. SURGEON UTILIZED RHBMP-2/ACS WITH ALLOGRAFT AND PLACED THE MIXTURE INSIDE A HOLLYWOOD CAGE RATHER THAN THE REQUIRED LT CAGE. ON (B)(6) 2009, PATIENT WAS DIAGNOSED WITH BONY OVERGROWTH, FORAMINAL STENOSIS, LUMBAR RADICULOPATHY, AND OTHER BODILY INJUIRES AND RELATED SEQUELAE. PATIENT REPORTEDLY EXHIBITED CONTINUING BACK PAIN AND RADICULOPATHIES AND OTHER RELATED SEQUELAE. AS A RESULT, PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT, INCLUDING HAVING TO UNDERGO AN ADDITIONAL SPINE SURGERY ON (B)(6) 2009 AND AGAIN ON (B)(6) 2009 TO TREAT HER INJURIES AND RELATED SEQUELAE. ON (B)(6) 2010 IT WAS REPORTED THAT THIS WAS THE LAST DAY THE PATIENT COULD WORK DUE TO LUMBAR DISPLACEMENT AND LUMBAR DISC DEGENERATION. THE PATIENT WAS SAID TO HAVE THE RESTRICTIONS AND LIMITATIONS OF: NO PROLONGED WALKING, SITTING, OR STANDING, NO HEAVY LIFTING, NO TWISTING, NO BENDING, NO KNEELING, NO PUSHING, AND NO TRAVELING DISTANCES. BETWEEN 2010 AND 2014 THERE ARE MULTIPLE DISABILITY CLAIM CORRESPONDENCE/REPORTS MENTIONING THE PATIENT'S BACK AND LEG PAIN; LEG NUMBNESS; AND LIMITATIONS AND RESTRICTIONS. BETWEEN 2010 AND 2014 THERE ARE MULTIPLE DISABILITY CLAIM CORRESPONDENCE/REPORTS MENTIONING THE PATIENT'S BACK AND LEG PAIN; LEG NUMBNESS; AND LIMITATIONS AND RESTRICTIONS. ON (B)(6) 2010 - DISABILITY CLAIM INTERVIEW: IT WAS REPORTED THAT THE PATIENT DISPLAYED "FAINT SIGNS OF PHYSICAL PAIN AND DISCOMFORT." THE PATIENT COMPLAINED OF BACK PAIN AFTER 45 MINUTES OF SITTING. THE PATIENT REPORTED THAT THEY EXPERIENCE CONSTANT PAIN IN THEIR LOW BACK WHICH SHOOTS TO THE LEFT LEG AND FOOT. THAT SENSATION WAS A BURNING THROB THAT FELT LIKE THE LEG WAS ASLEEP. THE PATIENT ALSO REPORTED DEPRESSION SECONDARY TO THE DISABILITY AND WEIGHT GAIN AND DROWSINESS SECONDARY TO MEDICATIONS. THE PATIENT CLAIMED THAT SINCE THEIR (B)(6) 2009 DURA REPAIR THEY HAD EXPERIENCED A GRADUAL DECLINE AND IN (B)(6) OF 2010 THEY WERE ADVISED BY THEIR PHYSICIAN TO STOP WORKING. THE PATIENT WAS ON LYRICA AND HYDROCODONE. ON (B)(6) 2014 IT WAS REPORTED THAT THE PATIENT UNDERWENT EPIDURAL INJECTIONS WITH SOME RELIEF. ON (B)(6) 2014 IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY, DECOMPRESSION, AND FUSION - C5-6, C6-7 LEVELS. ON (B)(6) 2014 IT WAS REPORTED THAT THE PATIENT PRESENTED WITH IMPROVING PREOPERATIVE PAIN. THE PATIENT NO LONGER NEEDED TO USE A COLLAR. ON (B)(6) 2014 IN WAS REPORTED THAT THE PATIENT COULD INCREASE THEIR ACTIVITIES. PER BILLING RECORDS, BETWEEN 2007 AND (B)(6) 2014 THE PATIENT PARTICIPATED IN VARIOUS HEALTH, DENTAL, AND RADIOLOGIC EXAMS. ON (B)(6) 2013 THE PATIENT PRESENTED WITH NECK PAIN AND RIGHT-SIDED CERVICAL RADICULAR SYMPTOMS. THE PATIENT UNDERWENT CERVICAL SPINE X-RAYS WHICH DEMONSTRATED MODERATE CERVICAL SPONDYLOSIS C5-6 WITH ASSOCIATED MUSCLE SPASM AND MINIMAL ANTERIOR C4 SUBLUXATION. THE PATIENT ALSO UNDERWENT A CERVICAL MRI WHICH SHOWED NO CANAL OR NERVE COMPROMISE AT ANY LEVEL; MODERATE DISC DEGENERATION AND DISC HEIGHT LOSS AT C5-6 WITH A VERY BROAD BASED 1 MM SYPONDYLOTIC PROTRUSION, MID FACET AND UNCOVERTEBRAL ARTHROSIS; MODERATE DIS DEGENERATION AT C6-C7 WITH A VERY BROAD BASED 2MM DORSAL DISC PROTRUSION AND MILD UNCONVERTEBRAL JOINT ARTHROSIS; AND A BROAD BASED LEFTWARD LATERALIZING 1 MM DORSAL DISC PROTRUSION AT C3-C4, WITH MODERATE UNCONVERTEBRAL JOINT ARTHROSIS. THE CERVICAL CORD WAS NORMAL IN SIGNAL AND CALIBER. THERE WAS MODERATE DISC DEHYDRATION AND HEIGHT LOSS AT C5-6 AND C6-7 LEVELS.
(B)(6) 2004: THE PATIENT UNDERWENT NERVE CONDUCTION STUDIES. IMPRESSION: PROLONGED LATENCIES OF THE MEDIAN NERVE SENSORY WITH AN EARLY ENTRAPMENT SUCH AS CARPAL TUNNEL SYNDROME BILATERALLY; NORMAL H-REFLEXES BILATERALLY; ELECTROMYOGRAPHY SHOWS EVIDENCE OF DENERVATION ON THE LEFT ANTERIOR TIBIALUS MUSCLE, CONSISTENT WITH AN L5 RADICULOPATHY AT THIS LEVEL. (B)(6) 2006 THE PATIENT PRESENTED FOR AN OFFICE VISIT COMPLAINING OF BACK PAIN WITH NUMBNESS AND TINGLING INTO THE LEG. IMPRESSION: POSSIBLE RECURRENT DISC HERNIATION. (B)(6) 2006: THE PATIENT PRESENTED WITH PAIN STILL IN HER BACK AND SOME IN HER LEG, STATING THE INJECTION DID NOT REALLY HELP. ON (B)(6) 2006 THE PATIENT PRESENTED WITH DDD, SPONDYLOLISTHESIS AND LUMBAR STENOSIS. PATIENT UNDERWENT A L5-S1 DECOMPRESSION AND POSTERIOR FUSION USING PEDICLE SCREW INSTRUMENTATION WITH RHBMP-2/ACS AND INTRAOPERATIVE X-RAYS. PER THE OP NOTES, ONCE THE DECOMPRESSION WAS COMPLETE, THE DISC SPACE WAS ENTERED AND THE DISC SPACE CLEANED OUT WITH CURETTES AND RASPS AND THE ENDPLATES DECORTICATED WITH 11-MM TAPERED HOLLYWOOD INTERBODY FUSION DEVICE FILLED WITH RHBMP-2/ACS AND ALLOGRAFT WAS PLACED IN THE DISC SPACE WITH GOOD FIT. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6) 2006: THE PATIENT UNDERWENT LUMBAR SPINE X-RAYS. IMPRESSION: INTACT POSTERIOR FUSION AT THE L5 AND S1 LEVELS. THE PATIENT WAS DISCHARGED HOME. (B)(6) 2006: THE PATIENT PRESENTED FOR FOLLOW UP WITH NEW MRI. THE MRI SHOWED DISK HERNIATION WITH ANNULAR TEARING AND DEGENERATION AT L4-5 ABOVE THE PREVIOUS SURGERY. IT LOOKS LIKE IT HAS GOTTEN WORSE SINCE BEFORE. DOCTOR STATES HE BELIEVES HER FALL PROBABLY DID IT. ON (B)(6) 2006 THE PATIENT PRESENTED WITH L4-5 DISC HERNIATION, DEGENERATION AND ANNULAR TEARING. THE PATIENT UNDERWENT L4-5 LAMINECTOMY, DISCECTOMY, AND EXTENSION OF FUSION FROM L5-S1 TO L4-5 USING LAGUNA PEDICLE SCREWS, HOLLYWOOD INTERBODY DEVICE, ALLOGRAFT, RHBMP-2/ACS, AND LOCAL BONE. PER THE SURGEON'S NOTES, THE PATIENT HAS A "LONG HISTORY OF BACK PROBLEMS, STATUS POST L5-S1 FUSION SIX MONTHS AGO WITH INITIALLY GOOD RESULTS, NOW WORSENING OF PAIN OVER THE LAST MONTH AFTER A FALL. MRI SCAN SHOWED DISC HERNIATION AND STENOSIS ON THE LEFT AT L4-L5 WITH ANNULAR TEARING AND DISC DEGENERATION AT L4-L5." PER THE OP NOTES, THE ENDPLATES WERE DECORTICATED AND AN INTERBODY FUSION DEVICE WAS FILLED WITH ALLOGRAFT AND RHBMP-2/ACS AND WAS PLACED INTO THE DISC SPACE WITH GOOD FIT. INTRAOPERATIVE RADIOGRAPHS WERE TAKEN. NO PATIENT COMPLICATIONS WERE NOTED. (B)(6) 2006: THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE. IMPRESSION: PEDICLE SCREWS AND POSTERIOR INTERCONNECTING RODS EXTEND F ROM L4-S1 WITH INTERBODY BONE GRAFT AT L4-5 AND L5-S1; ADYNAMIC ILEUS. (B)(6) 2006/(B)(6) 2007: THE PATIENT PRESENTED FOR FOLLOW UP WITH PAIN SLIGHTLY IMPROVING. X-RAYS SHOW THE HARDWARE AND FUSION TO BE INTACT. (B)(6) 2009 PATIENT PRESENTED WITH BACK AND LEFT LEG PAIN AND NUMBNESS WITH DECREASED RANGE OF MOTION IN HER BACK. IMPRESSION: LUMBAR DISK HERNIATION, STATUS POST PREVIOUS FUSION. (B)(6) 2009 PATIENT PRESENTED WITH BACK AND LEG PAIN. IMPRESSION: L4-5 FORAMINAL STENOSIS. (B)(6) 2009: THE PATIENT PRESENTED WITH BACK AND LEFT LEG PAIN AND NUMBNESS, WITH DECREASED RANGE OF MOTION IN HER BACK. IMPRESSION: L4-5 STENOSIS. TREATMENT PLAN: IT LOOKS LIKE THE BONY OVERGROWTH WE SAW ON THE MYELOGRAM WAS SYMPTOMATIC AND WAS ALLEVIATED BY THE INJECTION. DECOMPRESSION AT THAT LEVEL WOULD BE APPROPRIATE. (B)(6) 2010: THE PATIENT PRESENTED WITH BACK AND LEG PAIN WITH DECREASED RANGE OF MOTION IN THE BACK. MRI DOES NOT SHOW ANY DISK HERNIATION. IMPRESSION: LUMBAR DISK HERNIATION; STENOSIS; AND CHRONIC RADICULOPATHY. (B)(6) 2010: THE PATIENT UNDERWENT A CT SCAN OF THE LUMBAR SPINE DUE TO LUMBAR RADICULOLPATHY. IMPRESSION: STATUS POST LAMINECTOMY AND FUSION AT L4-5 AND L5-S1 LEVELS, FUSION APPEARS SOLID AT BOTH LEVELS, POSTERIOR INSTRUMENTATION HAS BEEN REMOVED; MODERATE LEFT L4-5 CENTRAL CANAL STENOSIS; MULTIPLE LEVEL BILATERAL LUMBAR FACET ARTHROSIS. (B)(6) 2010/(B)(6) 2011: THE PATIENT PRESENTED WITH BACK AND LEFT LEG PAIN AND DECREASED RANGE OF MOTION IN HER BACK. IMPRESSION: LUMBAR DISK HERNIATION, STENOSIS, AND CHRONIC RADICULOPATHY. (B)(6) 2012/(B)(6) 2013: THE PATIENT PRESENTED WITH BACK PAIN GOING DOWN THE LEG AND DECREASED RANGE OF MOTION IN HER BACK. IMPRESSION: LUMBAR DISK HERNIATION AND STENOSIS WITH ARACHNOIDITIS AND CHRONIC RADICULOPATHY. (B)(6) 2013: THE PATIENT PRESENTEDWITH NECK PAIN GOING DOWN THE RIGHT ARM THAT HAS DEVELOPED SINCE SEPTEMBER. THE PATIENT HAS DECREASED RANGE OF MOTION OF HER NECK AND DECREASED SENSATION IN THE C6 DISTRIBUTION ON THE RIGHT COMPARED TO THE LEFT. MRI SCAN DOES SHOW DEGENERATIVE DISK DISEASE FROM C3-7 WITH DISK SPACE NARROWING AND STENOSIS AT C5-6 AND C6-7. IMPRESSION: CERVICAL STENOSIS. (B)(6) 2014: THE PATIENT PRESENTED WITH CERVICAL RADICULOPATHY AND UNDERWENT RIGHT C5-6 AND C6-7 TRANSFORAMINAL EPIDURAL STEROID IN JECTIONS. NO PATIENT COMPLICATIONS WERE REPORTED. (B)(6) 2014: THE PATIENT PRESENTED WITH NECK PAIN. X-RAYS SHOW THE PATIENT'S HARDWARE IS INTACT AND THE FUSION IS PROGRESSING. IMPRESSION: CERVICAL DISC HERNIATION AND STENOSIS, STATUS POST FUSION. ON (B)(6) 2004: THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE DUE TO BACK PAIN AND LEFT LEG NUMBNESS. THE INTERVERTEBRAL DISC SPACE HEIGHTS ARE FAIRLY WELL MAINTAINED EXCEPT FOR PERHAPS MILD DISK SPACE NARROWING AT L5-S1. THERE IS NO SIGNIFICANT SPONDYLOSIS. THERE IS NO SPONDYLOLISTHESIS AND NO SPONDYLOLYSIS. THERE IS MINIMAL ANTERIOR WEDGING OF THE CENTRA OF T11 THROUGH L4. THERE IS NO ACTUAL FRACTURE DEMONSTRATED. THERE IS SLIGHT CURVATURE OF THE LUMBAR SPINE CONVEX TOWARDS THE RIGHT WHICH MAY BE POSITIONAL IN NATURE. (B)(6) 2013: THE PATIENT PRESENTED WITH BILATERAL HYPOPLASIA WITH ASYMMETRY. THE PATIENT UNDERWENT A BILATERAL AUGMENTATION MAMMOPLASTY IN THE SUBPECTORAL PLANE UTILIZING A DUAL PLANE TECHNIQUE THROUGH AN INFRAMAMMARY APPROACH UTILIZING SILICONE GEL IMPLANTS BILATERALLY. NO PATIENT COMPLICATIONS WERE NOTED.
ON (B)(6) 2004: THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE DUE TO BACK PAIN AND LEFT LEG NUMBNESS. THE INTERVERTEBRAL DISC SPACE HEIGHTS ARE FAIRLY WELL MAINTAINED EXCEPT FOR PERHAPS MILD DISK SPACE NARROWING AT L5-S1. THERE IS NO SIGNIFICANT SPONDYLOSIS. THERE IS NO SPONDYLOLISTHESIS AND NO SPONDYLOLYSIS. THERE IS MINIMAL ANTERIOR WEDGING OF THE CENTRA OF T11 THROUGH L4. THERE IS NO ACTUAL FRACTURE DEMONSTRATED. THERE IS SLIGHT CURVATURE OF THE LUMBAR SPINE CONVEX TOWARDS THE RIGHT WHICH MAY BE POSITIONAL IN NATURE. (B)(6) 2013: THE PATIENT PRESENTED WITH BILATERAL HYPOPLASIA WITH ASYMMETRY. THE PATIENT UNDERWENT A BILATERAL AUGMENTATION MAMMOPLASTY IN THE SUBPECTORAL PLANE UTILIZING A DUAL PLANE TECHNIQUE THROUGH AN INFRAMAMMARY APPROACH UTILIZING SILICONE GEL IMPLANTS BILATERALLY. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2008 THE PATIENT PRESENTED WITH EPIGASTRIC /ABDOMINAL PAIN AND UNDERWENT A PROCEDURE WHICH DEMONSTRATED CHEMICAL/REFLUX GASTROPATHY AND HYPERPLASTIC GASTRIC POLYPS. ON (B)(6) 2002 PER BILLING RECORDS THE PATIENT PRESENTED IN ER WITH ABDOMINAL PAIN AND UNDERWENT VARIOUS LABS INCLUDING BUT NOT LIMITED TO AN ACUTE HEPATITIS AND LIVER PANELS. THE PATIENT ALSO UNDERWENT AN ABDOMINAL ULTRASOUND, CHEST X-RAYS, AND AN EKG. ON (B)(6) 2004 PER BILLING RECORDS THE PATIENT PRESENTED IN ER WITH ACUTE PHARYNGITIS. ON (B)(6) 2003 PER BILLING RECORDS THE PATIENT PRESENTED TO ER AND WAS ADMITTED TO HOSPITAL WITH ACUTE APPENDICITIS. ON (B)(6) 2003 PER BILLING RECORDS THE PATIENT UNDERWENT AN ABDOMINAL/PELVIC CT SCAN, X-RAYS AND MULTIPLE LABS AND UNDERWENT SURGERY. ON (B)(6) 2003 THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2013 INTRA-OPERATIVE X-RAYS WERE TAKEN AND CONFIRMED POSTERIOR FUSION OF THE LUMBAR SPINE AT THE LS AND S 1 LEVELS. ON (B)(6) 2006 THE PATIENT PRESENTED WITH BACK PAIN AND LEFT LEG NUMBNESS AND UNDERWENT A LUMBAR SPINE MRI WHICH DEMONSTRATED NO ACUTE FRACTURES OR SPONDYLOLISTHESIS WITHIN THE LUMBAR SPINE. THE PATIENT WAS STATUS POST POSTERIOR LUMBAR FUSION AT THE LS AND S1 LEVELS AS WELL AS INTERBODY FUSION AT THE LS-S 1 LEVELS. THE HARDWARE AND INTERBODY FUSION SHOWED SIGNIFICANT INTERVAL CHANGE INPOSITION OR ALIGNMENT IN COMPARISON TO PREVIOUS X-RAYS. A LIKELY INTRA-OSSEOUS GEODE WAS SEEN WITHIN THE LEFT LATERAL ASPECT OF THE L5 VERTEBRAL BODY MEASURING UP TO 1.8 CM. THE CONUS WAS LOCATED AT THE L1 VERTEBRAL BODY LEVEL. THERE WAS NO ABNORMAL SIGNAL ORIGINATING FROM THE SPINAL CORD. THERE WAS A BROAD BASED POSTERIOR DISC BULGE AT THE L4-L5 LEVEL RESULTING IN MODERATE BILATERAL NEURAL BILATERAL FORAMINAL STENOSIS, LEFT GREATER THAN RIGHT, ON (B)(6) 2009 THE PATIENT PRESENTED WITH LUMBAR PAIN AND LEFT LEG NUMBNESS AND UNDERWENT A LUMBAR SPINE CT WHICH DEMONSTRATED NO EVIDENCE OF LOOSENING OF INSTRUMENTATION. THERE WAS SOLID INTERBODY FUSION EVIDENT AT LS-S1 LEVEL. THERE WAS MILD TO MODERATE CRANIOCAUDAL DIMENSION NEURAL FORAMINAL STENOSIS ON THE LEFT L4-L5 LEVEL. THERE WAS MILD MULTILEVEL BILATERAL LUMBAR FACET ARTHROSIS. IT SHOULD BE NOTED THAT AT L4-L5 "THE INTERBODY FUSION GRAFT IS DIMINUTIVE AND APPEARS FRAGMENTED, THERE IS NOT CONVINCING EVIDENCE OF BRIDGING BETWEEN THE L4 INFERIOR AND S1 SUPERIOR ENDPLATES; HOWEVER, SOLID APPEARING RIGHT INTER-TRANSVERSE OSSEOUS FUSION GRAFT IS NOTED AND THERE IS EVIDENCE OF SOLID FACETAL EFFUSION ON THE RIGHT杠A CT MYELOGRAM WAS NEGATIVE FOR LUMBAR VENTRAL EXTRA-DURAL DEFECT. RIGHT L4-L5 INTER-TRANSVERSE OSSEOUS FUSION GRAFT WAS NOTED. ANTERIOR INTERBODY FUSION GRAFTS WERE PRESENT AT L4-L5 AND L5-S1. ON (B)(6) 2010 THE PATIENT PRESENTED WITH LOW BACK PAIN WITH NUMBNESS, AND TINGLING IN THE LEFT LEG. A LUMBAR SPINE MRI SHOWED MILD FACET OSTEOARTHRITIS AT L1-2 AND L2-3. AT L3-4 THERE WAS MILD REDUCTION OF DISC SPACE AND NO SIGNIFICANT EVIDENCE OF PSEUDOARTHROSIS. ON (B)(6) 2010 THE PATIENT HAD UNDERGONE A CT SCAN. IT SHOULD BE NOTED THAT IN THE "FINDING" NARRATIVE IT STATED THAT AT L4-5 LEVEL THAT "...THE INTERBODY FUSION GRAFT LARGELY APPEARS FRAGMENTED, BUT THERE IS EVIDENCE OF OSSEOUS BRIDGING BETWEEN L4 INFERIOR AND L5 SUPERIOR END PLATES CENTRALLY... THERE IS SOLID FACETAL FUSION ON THE RIGHT. POSTEROLATERAL OSSEOUS FUSION GRAFT IS PRESENT ON THE RIGHT SIDE AS WELL. THERE IS SOLID OSSEOUS BRIDGING BETWEEN RIGHT L3 AND L4 LEVELS POSTEROLATERALLY ON THE RIGHT SIDE" ON (B)(6) 2013, PER BILLING RECORDS, THE PATIENT PRESENTED FOR BREAST SUTURE REMOVAL. ON (B)(6) 2013, PER BILLING RECORDS, THE PATIENT PRESENTED FOR A POST OP (MAMMOPLASTY) F/U.
ON (B)(6) 2009 THE PATIENT'S URINE LAB CULTURES WHICH WERE POSITIVE FOR ESCHERICHIA COLI. MEDICATION PRESCRIBED: GENTAMICIN. ON (B)(6) 2009 THE PATIENT PRESENTED WITH NUMBNESS IN THE LEFT LEG WITH TINGLING. MEDICATIONS: LYRICA ON (B)(6) 2009 THE PATIENT PRESENTED WITH BACK AND LEG PAIN. THE LEG PAIN WAS ON THE LEFT SIDE AND WENT DOWN TO THE TOP OF THE FOOT. THE PATIENT ALSO PRESENTED DECREASED ROM. ON (B)(6) 2009 THE PATIENT WAS LISTED WITH THE DIAGNOSIS OF SYMPTOMATIC HARDWARE (LUMBAR). THE PATIENT UNDERWENT VARIOUS LABS. ON (B)(6) 2009 THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2009 THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2009 THE PATIENT PRESENTED WITH WEAKNESS BUT NO SIGNIFICANT BACK OR LEG PAIN AND NO HEADACHES. IN A (B)(6) 2010 DATED DISABILITY DETERMINATION FORM THE PATIENT'S PRIMARY DIAGNOSIS WAS LISTED AS LUMBAR HERNIATION WITH CHRONIC BACK PAIN. IN AN (B)(6) 2010 DATED DISABILITY FUNCTION REPORT THE PATIENT REPORTED HAVING TO TAKE PAIN MEDICATION REGULARLY WHICH AFFECTED THEIR ABILITY TO DRIVE, CONCENTRATE AND COMPLETE ACTIVITIES. THE PATIENT ALSO REPORTED DECREASED ROM, STIFFNESS, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, THE NEED FOR HELP THROUGHOUT THE DAY, DIFFICULTY SLEEPING, DIFFICULTY FOCUSING, INCREASED FEELINGS OF ANGER AND SHORT TEMPEREDNESS, AND INCREASED ALIENATION FROM OTHER PEOPLE -ALL SECONDARY TO PAIN. MEDICATIONS LISTED: HYDROCODONE AND LYRIC. SIDE EFFECTS OF MEDICATION THE PATIENT WAS TAKING WERE LISTED AS DROWSINESS, IRRITABILITY, INABILITY TO DRIVE, CONCENTRATION AND MEMORY ISSUES. ON (B)(6) 2011 THE PATIENT PRESENTED WITH EAR PAIN AND SORE THROAT (ONSET 4 DAYS PRIOR). DIAGNOSIS: PHARYNGITIS, STREP. IT SHOULD BE NOTED THAT THE PATIENT HAD LOST APPROX. 30 POUNDS SINCE 2006. MEDICATION: ZITHROMAX. ON (B)(6) 2013 THE PATIENT PRESENTED WITH RIGHT SHOULDER PAIN. PER THE ENCOUNTER NOTES THE PATIENT HAD BEEN DEALING WITH THE PAIN FOR APPROX. 3 -4 WEEKS. MEDICATIONS: VICODIN, CELEBRAX, LYRICA - ALL FOR BACK. ULTRAM AND NORCO FOR SHOULDER. ON (B)(6) 2013 THE PATIENT PRESENTED WITH STIFF SHOULDERS AND THE ASSESSMENT OF ADHESIVE CAPSULITIS. MEDICATIONS: ULTRAM AND NORCO.
(B)(6) 2007: PATIENT PRESENTED FOR FOLLOW UP WITH SOME OCCASIONAL PAIN. X-RAYS SHOWED THE HARDWARE INTACT AND FUSION SOLID. (B)(6) 2008: PATIENT PRESENTED WITH SEVERE ABDOMINAL PAIN. ASSESSMENT: GERD. (B)(6) 2008: PATIENT PRESENTED FOR FOLLOW UP. (B)(6) 2008: PATIENT PRESENTED WITH EPIGASTRIC ABDOMINAL PAIN. THE PAIN WAS WORSENING. THIS PAIN SOME TIMES WOKE HER UP HOWEVER THE PATIENT WAS NOT SURE WHETHER IT WAS BACK PAIN OR THE EPIGASTRIC PAIN THAT CAUSED AWAKENING. PATIENT HAD MILD WEIGHT LOSS. PATIENT ALSO HAD QUITE SUBSTANTIAL AMOUNT OF EPIGASTRIC FULLNESS AS WELL AS POSTPRANDIAL BELCHING. IMPRESSION: POST PRANDIAL EPIGASTRIC PAIN, ETIOLOGY UNCLEAR. (B)(6) 2008: PATIENT PRESENTED WITH SORE THROAT AND LOW GRADE FEVER. (B)(6) 2009: PATIENT PRESENTED WITH THE COMPLAINT OF UTI. ON (B)(6) 2009 IMPRESSION: LUMBAR DISK HERNIATION AND DEGENERATION, STATUS POST FUSION. (B)(6) 2009: PATIENT UNDERWENT LUMBAR MYELOGRAM DUE TO LUMBAR PAIN AND LEFT LEG NUMBNESS. IMPRESSION: 1. NEGATIVE FOR SIGNIFICANT LUMBAR VENTRAL EXTRADURAL DEFECT. 2. STATUS POST L4-L5-S1 GLOBAL FUSION. PATIENT UNDERWENT POSTMYELOGRAM CT SCAN OF LUMBAR SPINE DUE TO LUMBAR PAIN AND LEFT LEG NUMBNESS. IMPRESSION: STATUS POST L4-L5-S1GLOBAL FUSION, RIGHT POSTEROLATERAL OSSEOUS FUSION MASS AT THESE LEVELS APPEARS SOLID. THERE IS NOT EVIDENCE OF LOOSENING OF INSTRUMENTATION. SOLID INTERBODY FUSION IS EVIDENT AT L5-S1 LEVEL. 2. MILD TO MODERATE CRANIOCAUDAL DIMENSION NEURAL FORAMINAL STENOSIS ON THE LEFT L4-L5 LEVEL. 3. NEGATIVE FOR SIGNIFICANT LUMBAR POSTERIOR INTERVERTEBRAL DISC BULGE OR PROTRUSION. 4. MILD MULTILEVEL BILATERAL LUMBAR FACET ARTHROSIS. (B)(6) 2009 IMPRESSION: LUMBAR STENOSIS, STATUS POST DECOMPRESSION WITH INTRAOPERATIVE DURAL LEAK. (B)(6) 2010 IMPRESSION: LUMBAR DISC HERNIATION, DEGENERATION, AND STENOSIS, CHRONIC RADICULOPATHY. (B)(6) 2010: PATIENT UNDERWENT LUMBAR MYELOGRAM DUE TO LUMBAR RADICULOPATHY. FINDINGS: STATUS POST LAMINECTOMY AND FUSION AT L4-L5-S1 LEVELS. LUMBAR SUBARACHNOID SPACE IS PATENT. SIGNIFICANT LUMBAR VENTRAL EXTRADURAL DEFECT IS NOT SEEN. BILATERAL LUMBAR NERVE ROOT SLEEVES FILL SYMMETRICALLY WITH CONTRAST. (B)(6) 2013: PATIENT PRESENTED WITH KIDNEY INFECTION. (B)(6) 2013: PATIENT PRESENTED WITH PAIN IN RIGHT SHOULDER. ASSESSMENT: SHOULDER PAIN. (B)(6) 2013: PATIENT PRESENTED WITH TINGLING IN RIGHT ARM/HAND- LOSS OF STRENGTH. PATIENT UNDERWENT CERVICAL SPINE MRI WITHOUT CONTRAST DUE TO RIGHT SIDED CERVICAL RADICULOPATHY SYMPTOMS. IMPRESSION: 1. NO CANAL OR NERVE ROOT COMPROMISE IS SEEN AT ANY LEVEL. 2. MODERATE DISC DEGENERATION AND DISC HEIGHT LOSS AT C5-C6, WITH VERY BROAD BASED 1 MM SPONDYLOTIC PROTRUSION, MILD FACET AND UNCOVERTEBRAL JOINT ARTHROSIS. 3. MODERATE DISC DEGENERATION AT C6-C7, WITH VERY BROAD BASED 2 MM DORSAL DISC PROTRUSION AND MILD UNCOVERTEBRAL JOINT ARTHROSIS. 4. BROAD BASED LEFTWARD LATERALIZING 1 MM DORSAL DISC PROTRUSION AT C3-C4, WITH MODERATE LEFT UNCOVERTEBRAL JOINT ARTHROSIS. PATIENT UNDERWENT CERVICAL SPINE X-RAY DUE TO PAIN. IMPRESSION: MODERATE CERVICAL SPONDYLOSIS C5-6 WITH ASSOCIATED MUSCLE SPASM AND MINIMAL ANTERIOR C4 SUBLUXATION. (B)(6) 2014: PATIENT PRESENTED WITH NECK AND ARM PAIN. IMPRESSION: CERVICAL STENOSIS. (B)(6) 2014: PATIENT PRESENTED WITH HISTORY OF NECK AND BACK PAIN UNRESPONSIVE TO CONSERVATIVE TREATMENT INCLUDING MEDICATION, PHYSICAL THERAPY AND EPIDURAL INJECTIONS. IMAGING STUDIES SHOWED DISC HERNIATION WITH STENOSIS AT C5-C6 AND C6-C7. PRE-OP DIAGNOSIS: C5-C6, C6-C7 DISC HERNIATION AND STENOSIS. PATIENT UNDERWENT FOLLOWING PROCEDURES: C5-C6, C6-C7 ANTERIOR CERVICAL DISCECTOMY, DECOMPRESSION WITH REMOVAL OF OSTEOPHYTES UNDER THE MICROSCOPE, AND ANTERIOR SPINAL FUSION WITH PEEK INTERBODY FUSION DEVICE, ALLOGRAFT DEMINERALIZED BONE MATRIX, AND INDUS PLATE. NO COMPLICATIONS REPORTED. (B)(6) 2014: PATIENT UNDERWENT COLONOSCOPY DUE TO INDICATIONS OF SCREENING FOR COLON CANCER AND COLORECTAL CANCER IN DISTANT RELATIVE. IMPRESSION: THE EXAMINED PORTION OF THE ILEUM WAS NORMAL; ONE 6 MM POLYP IN THE PROXIMAL ASCENDING COLON; RESECTED AND RETRIEVED; TWO 6 TO 7 MM POLYPS IN THE SIGMOLD COLON, RESECTED AND RETRIEVED; NON-BLEEDING INTERNAL HEMORRHOIDS; THE EXAMINATION WAS OTHERWISE NORMAL. (B)(6) 2014: PATIENT PRESENTED WITH URINARY PROBLEM. IMPRESSION: URINARY TRACT INFECTION.
ON (B)(6) 2004, MRI OF THE LUMBAR SPINE INDICATED ¿POSTEROCENTRAL ANNULAR TEAR AT L4-5 AND L5-S1. 3-4MM POSTERIOR DISC PROTRUSION AT L4-5 ECCENTRIC TO THE LEFT ASSOCIATED WITH MILD TO MODERATE FACET ARTHROPATHY RESULTING IN MILD TO MODERATE MASS EFFECT UPON THE L5 DESCENDING NERVE ROOT ON THE LEFT AND MINIMAL ON THE RIGHT¿ 6-7 MM BROAD-BASED POSTERIOR DISC EXTRUSION AT L5-S1 WITH MILD TO MODERATE MASS EFFECT UPON THE S1 DESCENDING NERVE ROOT ON THE LEFT.¿ ON (B)(6) 2004, THE PATIENT PRESENTED WITH FULL-THICKNESS BURN, RIGHT FOOT. THE PATIENT UNDERWENT L5-S1 LAMINECTOMY AND DISCECTOMY. PATHOLOGY REPORT OF THE DISC MATERIAL INDICATED ¿CARTILAGE WITH DEGENERATIVE CHANGES.¿ ON (B)(6) 2004, THE PATIENT PRESENTED FOR FOLLOWUP. PER THE PHYSICIAN¿S NOTES, ¿HER WOUND LOOKS FINE. HER PREOPERATIVE SYMPTOMS IN TERMS OF NUMBNESS, WEAKNESS AND PAIN HAVE IMPROVED.¿ ON (B)(6) 2006, THE PATIENT PRESENTED FOR AN OFFICE VISIT COMPLAINING OF BACK PAIN WITH NUMBNESS AND TINGLING INTO THE LEG. ON (B)(6) 2006, AN MRI OF THE LUMBAR SPINE INDICATED ¿RECURRENT 2MM DIFFUSE NONENHANCING ANNULAR DISC BULGE AT THE L5-S1 LEVEL. IT DOES NOT SIGNIFICANTLY AFFECT THE THECAL SAC OR THE S1 NERVE ROOTS.¿ ON (B)(6) 2006, PATIENT HAD LEFT L5 AND S1 NERVE ROOT BLOCKS AND EPIDURAL STEROID INJECTIONS. ON (B)(6) 2006, THE PATIENT PRESENTED WITH DDD, SPONDYLOLISTHESIS AND LUMBAR STENOSIS. PATIENT UNDERWENT A L5-S1 DECOMPRESSION AND POSTERIOR FUSION USING PEDICLE SCREW INSTRUMENTATION, RHBMP-2/ACS. ON (B)(6) 2006, PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN¿S NOTES, ¿SHE IS DOING BETTER. HER PAIN IS IMPROVED. SHE HAS SOME RESIDUAL PAIN.¿ ON (B)(6) 2006, PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN¿S NOTES, ¿SHE HAS SOME RESIDUAL PAIN BUT OTHERWISE IS DOING OKAY.¿ ON (B)(6) 2006, PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN¿S NOTES, ¿SHE FELL LAST FRIDAY INCREASING THE PAIN IN THE BACK AS WELL AS PAIN GOING DOWN THE LEFT LEG. ¿ X-RAYS TODAY SHOW NO NEW CHANGES.¿ ON (B)(6) 2006 MRI INDICATED ¿BROAD BASED POSTERIOR DISC BULGE AT THE L4-L5 LEVEL RESULTING IN MODERATE BILATERAL NEURAL BILATERAL FORAMINAL STENOSIS, LEFT GREATER THAN RIGHT.¿ ON (B)(6) 2006, THE PATIENT PRESENTED WITH L4-5 DISC HERNIATION, DEGENERATION AND ANNULAR TEARING. THE PATIENT UNDERWENT L4-5 LAMINECTOMY, DISCECTOMY, AND EXTENSION OF FUSION FROM L5-S1 TO L4-5 USING LAGUNA PEDICLE SCREWS, HOLLYWOOD INTERBODY DEVICE, ALLOGRAFT, RHBMP-2/ACS, AND LOCAL BONE. PER THE SURGEON¿S NOTES, THE PATIENT HAS A ¿LONG HISTORY OF BACK PROBLEMS, STATUS POST L5-S1 FUSION SIX MONTHS AGO WITH INITIALLY GOOD RESULTS, NOW WORSENING OF PAIN OVER THE LAST MONTH AFTER A FALL. MRI SCAN SHOWED DISC HERNIATION AND STENOSIS ON THE LEFT AT L4-L5 WITH ANNULAR TEARING AND DISC DEGENERATION AT L4-L5.¿ ON (B)(6) 2009, THE PATIENT PRESENTED WITH COMPLAINTS OF RECURRENT BACK AND LEFT LEG PAIN WITH SOME NUMBNESS. DECREASED RANGE OF MOTION WITH PAIN ON MOTION OF HER BACK WITH APPOSITIVE STRAIGHT LEG RAISE. X-RAYS INDICATED NO CHANGES IN THE HARDWARE OR FUSION. ON (B)(6) 2009, PATIENT PRESENTED WITH BACK AND LEFT LEG PAIN AND NUMBNESS. ON (B)(6) 2009, MRI OF THE LUMBAR SPINE INDICATED ¿NEGATIVE FOR SIGNIFICANT INTERVERTEBRAL DISC BULGE OR PROTRUSION AT L1-L4 LEVELS. STATUS POST POSTERIOR FUSION WITH METALLIC INSTRUMENTATION AND ANTERIOR INTERBODY FUSION AT L4-L5-S1 LEVELS. MILD POSTERIOR SPONDYLOSIS AT L5-S1 LEVEL. VERY MILD MULTILEVEL BILATERAL LUMBAR FACET ARTHROSIS.¿ ON (B)(6) 2009 CT SCAN INDICATED ¿SOLID INTERBODY FUSION IS EVIDENT AT L5-S1 LEVEL. MILD TO MODERATE CRANIOCAUDAL DIMENSION NEURAL FORAMINAL STENOSIS ON THE LEFT L4-L5 LEVEL.¿ ON (B)(6) 2009, PATIENT PRESENTED WITH BACK AND LEG PAIN. ON (B)(6) 2009, PATIENT UNDERWENT LEFT L4 SELECTIVE EPIDURAL STEROID INJECTION, LEFT L3-4 EPIDURAL STEROID INJECTION, AND LUMBAR EPIDUROGRAM. ON (B)(6) 2009, THE PATIENT PRESENTED WITH L4-5 STENOSIS AND RETAINED LUMBAR HARDWARE. THE PATIENT UNDERWENT SURGERY CONSISTING OF HARDWARE REMOVAL L4-S1, EXPLORATION OF THE FUSION MASS AND REVISION L4-5 LAMINECTOMY AND DECOMPRESSION. PER THE OPERATIVE REPORT, ¿IMAGING STUDIES INCLUDING X-RAYS, MRI, AND MYELOGRAM SHOWED SOME BONY STENOSIS AT L4-L5 ON THE LEFT DUE TO BONY OVERGROWTH WITH INTACT HARDWARE AND FUSION FROM L4 TO S1.¿ THERE WERE NO NOTED COMPLICATIONS. ON (B)(6) 2009, PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN¿S NOTES, ¿SHE HAS HAD IMPROVEMENT IN HER PREOPERATIVE LEG PAIN AND NUMBNESS, BUT STILL HAS PERSISTENT HEADACHES. IT IS WORSE WHEN SHE IS UPRIGHT WITH NAUSEA.¿ ON (B)(6) 2009, PATIENT UNDERWENT REVISION SURGERY TO CORRECT DURAL TEAR WITH CSF LEAK. ON (B)(6) 2009, PATIENT PRESENTED FOR FOLLOW UP COMPLAINING OF BACK PAIN. PER THE PHYSICIAN¿S NOTES, ¿HER BACK IS DOING WELL. SHE HAS NO SIGNIFICANT PAIN. SHE HAS REAR NUMBNESS IN THE LEG WHEN SHE OVERDOES IT, BUT OTHERWISE SHE IS DOING FINE. NO HEADACHES.¿ ON (B)(6) 2010, PATIENT PRESENTED WITH BACK AND LEG PAIN. PER THE PHYSICIAN¿S NOTES, ¿SHE HAS BEEN DOING A LOT OF TRAVELING AND BEING REAL ACTIVE OVER THE LAST 2 WEEKS AND HAS INCREASE IN LEFT LEG PAIN AND NUMBNESS. IT IS SIGNIFICANT. MEDICATIONS HAVE NOT HELPED ¿ SHE HAS DECREASED RANGE OF MOTION WITH SOME PAIN ON MOTION OF HER BACK. STRAIGHT LEG RAISE IS POSITIVE ON THE LEFT. SHE HAS SUBJECTIVELY DECREASED SENSATION AT THE L5-S1 DISTRIBUTION ON THE LEFT COMPARED TO THE RIGHT.¿ ON (B)(6) 2010, MRI INDICATED ¿POSTSURGICAL CHANGES NOTED AT L4-L5 AND L5-S1. INTRADISCAL CAGES HAVE BEEN PLACED AT THESE LEVELS THERE IS ANATOMIC ALIGNMENT ON AXIAL AND SAGITTAL VIEWS. THERE IS A FLUID COLLECTION POSTERIOR TO THE BODY OF L4 AND L5 BEGINNING AT THE L4-L5 DISC SPACE. THIS MEASURES APPROXIMATELY 3.5 CM CRANIOCAUDAL X2.5CM AP X 2.5CM TRANSVERSE. THERE IS PERIPHERAL ENHANCEMENT. THERE IS NO SPECIFIC EVIDENCE THAT THIS COLLECTION IS INFECTED. THIS COLLECTION MAY REPRESENT A RESOLVING SEROMA WITH POSTOPERATIVE ENHANCEMENT.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148829 | 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 |