CD HORIZON SPINAL SYSTEM
Report
- Report Number
- 1030489-2014-04473
- Event Type
- Injury
- Date Received
- November 20, 2014
- Date of Event
- February 12, 2014
- Report Date
- August 29, 2016
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4).
ADD'L INFO.
(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.
ADDITIONAL INFORMATION: IMAGE REVIEW IMAGE REVIEW: (B)(6) 2013 MULTIPLE PREOPERATIVE X-RAYS ARE SHOWN OF STANDING PATIENT WITH FORWARD FLEXED DEFORMITY. FILMS DO NOT SHOW CLEARLY THE DEFORMITY DUE TO POOR TECHNIQUE. ON (B)(6) 2014 SCOLIOSIS X-RAYS MULTIPLE PLANE FILMS ARE TAKEN OF AN EXTENSIVE SCOLIOSIS CONSTRUCT THAT SPANS FROM T3 TO THE ILIAC CREST. ANTERIOR GRADE 2 SPONDYLOLISTHESIS IS NOTED AT T2/3. INTERBODY SPACERS ARE NOTED AT L2/3, L3/4, L4/5 AND L5/S1. COMPRESSION FRACTURE DEFORMITIES ARE NOTED IN THE INFERIOR ENDPLATE OF L2, AND A 50% FLATTENING OF L3. ON (B)(6) 2013 SCOLIOSIS X-RAYS MULTIPLE LATERAL VIEWS SHOW EXTENDED CONSTRUCT FROM T2 TO THE ILIAC CREST. INTERBODY SPACERS ARE SEEN AT L4 AND L5. THERE ALSO APPEARS TO BE A COLLAPSED VERTEBRAL BODY AT L3. FRACTURE OF THE RODS CANNOT BE SEEN IN THESE STUDIES (B)(6) 2013 SCOLIOSIS X-RAYS MULTIPLE LATERAL VIEWS SHOW EXTENDED CONSTRUCT FROM T2 TO THE ILIAC CREST. INTERBODY SPACERS ARE SEEN AT L4 AND L5. THERE ALSO APPEARS TO BE A COLLAPSED VERTEBRAL BODY AT L3. FRACTURE OF THE RODS CANNOT BE SEEN IN THESE STUDIES. NO INTERVAL CHANGES ARE NOTED FROM (B)(6) 2013 STUDIES. ON (B)(6) 2014 SCOLIOSIS X-RAYS INTERVAL CHANGE IS NOTED AFTER FRACTURE OF RODS AT THE LEVEL OF THE T3 COMPRESSION FRACTURE. BOTH RODS ARE BROKEN ABOVE THE L4 PEDICLE SCREWS. LATERAL CONNECTORS ARE USED AT L4/5 AND L1/2 CONNECTING TO RODS SEEN SPANNING THE FRACTURED RODS. ON (B)(6) 2014 SCOLIOSIS X-RAYS THIS STUDY FOR THE FIRST TIME SHOWS INTERBODY SPACERS NOW PLACED AT L2/3 AND L3/4. IN ADDITION BROKEN RODS ABOVE THE L4 SCREWS. BRIDGING RODS ARE CONNECTED THROUGH LATERAL CONNECTORS ABOVE L2 AND BELOW L4. NOW ALSO SEEN HOWEVER, IS ADDITIONAL ROD FRACTURE ABOVE THE L5 SCREWS BELOW THE BRIDGING RODS LEAVING THE CONSTRUCT NONFUNCTIONAL BETWEEN L4 AND L5. ON (B)(6) 2015 SCOLIOSIS X-RAYS ADDITIONAL INTERVAL REVISION HAS BEEN PERFORMED WITH BRIDGING RODS NOW EXTENDING FROM L1/2 TO BELOW L5. THESE BRIDGING RODS ARE STILL CONNECTED THROUGH LATERAL CONNECTORS AND ATTACH TO THE ORIGINAL RODS ONLY ABOVE AND BELOW AT TWO CONNECTION POINTS.
ADD'L INFO.
ADDITIONAL INFORMATION.
(B)(4).
A REVIEW OF PLAIN X-RAYS TAKEN 9/5/2014 SHOW T3-ILIUM ARTHRODESIS. THERE HAS BEEN A REVISION AT L3-4 WITH A BRIDGING ROD POST ROD FRACTURE. THERE IS NOW ALSO A ROD FRACTURE BELOW THE BRIDGED SEGMENT AT L4-5 BILATERALLY. INTERBODY GRAFTS ARE PRESENT AT L5-S1, L4-5, L3-4, AND L2-3. THERE IS A PAUCITY OF BONE GROWTH AT EACH OF THE INTERBODY LEVELS WHICH MAY HAVE CONTRIBUTED TO THE ROD FRACTURES.
IT WAS REPORTED THAT ON: (B)(6) 2004: THE PATIENT PRESENTED WITH NECK AND BACK PAIN. SHE UNDERWENT X-RAYS OF CERVICAL SPINE DUE TO PAIN POST MOTOR VEHICLE ACCIDENT. IMPRESSION: NO EVIDENCE OF FRACTURE OF THE CERVICAL SPINE; MINOR DEGENERATIVE CHANGE. SHE ALSO UNDERWENT X-RAYS OF THE LUMBOSACRAL SPINE. IMPRESSION: NO EVIDENCE OF FRACTURE OR DISLOCATION; EARLY ACETABULAR SPURRING AND JOINT SPACE NARROWING OF THE HIPS. ON (B)(6) 2007: THE PATIENT UNDERWENT CT OF HEAD-BRAIN DUE TO HEAD INJURY. IMPRESSION: NO EVIDENCE OF ACUTE INTRACRANIAL EVENT IDENTIFIED. SHE ALSO UNDERWENT X-RAYS OF THE SKULL. IMPRESSION: NO EVIDENCE OF DEPRESSED INJURY IDENTIFIED. ON (B)(6) 2009: THE PATIENT PRESENTED WITH HISTORY OF SEVERAL FALLS AND NECK PAIN. THE PAIN WAS DESCRIBED AS CONSTANT. THE PATIENT ALSO HAD NUMBNESS AT LEFT ARM AND WEAKNESS AT BOTH ARMS. ON (B)(6) 2009, PATIENT UNDERWENT MRI SCAN OF UPPER SPINAL CANAL DUE TO NECK PAIN. IMPRESSION: LIMITED STUDY DUE TO MOTION ARTIFACT; THERE IS HOWEVER SUGGESTION FOR MIDLINE HERNIATED NUCLEUS PULPOSES AT THE C3-4 AND AT THE C4-5 LEVELS. THE PATIENT WAS ALSO GIVEN 10 MG OF VALIUM ORALLY PRIOR TO THE MRI STUDY FOR CLAUSTROPHOBIA. ON (B)(6) 2013: THE PATIENT PRESENTED FOR A FOLLOW-UP OF CHRONIC BACK PAIN WITH RADICULAR PAIN TO HER BILATERAL LEGS. ON (B)(6) 2013: THE PATIENT PRESENTED FOR A FOLLOW-UP OF CHRONIC BACK PAIN. HER PAIN WAS GETTING WORSE AND WAS DESCRIBED AS NAGGING, SHARP, THROBBING AND GRABBING. SHE ALSO HAD DIFFICULTY WALKING DUE TO HER PAIN. ASSESSMENT: CHRONIC PAIN WITH OPOID DEPENDENCE; INSOMNIA; HEADACHES; ANXIETY; ANOREXIA.
IT WAS REPORTED THAT ON: (B)(6) 2013 THAT PATIENT WAS PRESENTED FOR OFFICE VISIT. ASSESSMENTS: 1) CHRONIC PAIN SYNDROME, 2) DEGENERATION OF LUMBAR OR LUMBOSACRAL INTERVERTEBRAL DISC, 3) SCOLIOSIS, 4) OPIOID TYPE DEPENDENCE, EPISODIC ABUSE.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE WHERE CHROME RODS WERE IMPLANTED. IT IS REPORTED THAT THE RODS WERE BROKEN APPROXIMATELY 9 MONTHS POST-OP AND SUFFERED PERMANENT AND SERIOUS INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT ON: (B)(6) 2011 PATIENT PRESENTED WITH ADMITTING DIAGNOSIS OF NON-UNION. ON (B)(6) 2013, THE PATIENT PRESENTED FOR PATHOLOGY EXAMINATIONS. ON (B)(6) 2014: THE PATIENT UNDERWENT NEUROVASCULAR ASSESSMENT LOWER EXTREMITY, PAIN ASSESSMENT, NEURO CHECKS, INCENTIVE SPIROMETRY AND OTHER PATIENT CARE. THE PATIENT UNDERWENT RADIOLOGICAL TEST OF THE CHEST AND RESPIRATION THERAPY. PATIENT¿S ACTIVE PROBLEMS LIST: ADDISON¿S DISEASE, ANXIETY, PRESSURE SORE, CONSTIPATION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DEPRESSION, FIBROMYALGIA, HIATAL HERNIA, HYPERTENSION, HYPOTHYROID, IRRITABLE BOWEL, MIGRAINES, PAIN, SCOLIOSIS, SEIZURE. ON (B)(6) 2014 THE PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN. PATIENT HAD BENT OVER EARLIER THAT DAY AND HAD HEARD A POP AND HAD EXPERIENCED SIGNIFICANCE PAIN IN LOWER EXTREMITIES. ON (B)(6) 2014 THE PATIENT UNDERWENT LATERAL EXTRA CAVITARY APPROACH TO L2-3, L3-4 THROUGH THE LEFT SIDE APPROACH. PREOPERATIVE DIAGNOSIS: SPINAL STENOSIS, FLAT BACK DEFORMITY, NON UNION. ON (B)(6) 2014 THE PATIENT UNDERWENT: REVISION OF LUMBAR INSTRUMENTATION L2 TO L4. 2. L2 TO L4 FUSION USING LOCAL BONE, ONE LARGE KIT OF BONE MORPHOGENIC PROTEIN, AND 10 ML OF GRAFT. PREOPERATIVE DIAGNOSIS: SPINAL STENOSIS; FLAT BACK DEFORMITY; NON UNION. PER-OP NOTES: DECORTICATION WAS THEN PERFORMED FROM L2 TO L4. SHE DID HAVE AN OBVIOUS NON UNION OF THE OSTEOTOMY SITE. THE CONNECTORS WERE PLACED ABOVE AND BELOW THE L2 AND BELOW THE L4 SCREWS. THE BONE GRAFT, WHICH WAS BASICALLY LOCAL BONE, BMP AND GRAFT WAS PLACED. THE RODS WERE THEN CUT, CONTOURED AND PLACED. AP AND LATERAL IMAGE SHOWED GOOD POSITION OF THE SPINE AS WELL AS THE INSTRUMENTATION. FINAL TORQUEING WAS PERFORMED. AGAIN, THE RODS WERE CHECKED USING IMAGE AND FELT TO BE IN GOOD POSITION. ON (B)(6) 2014 THE PATIENT UNDERWENT DLIF L2-3; L3-4 WITH 10 X 50MM 6DEGREE OFFSET PEEK CAGES FRO FUSION WITH BMP AND GRAFT. PREOPERATIVE DIAGNOSIS: SPINAL STENOSIS; FLAT BACK DEFORMITY; NON UNION. PER-OP NOTES: ONCE THE DISCECTOMY WAS PERFORMED, THE ENDPLATES WERE PREPARED WITH A RASP. IT WAS THEN TEMPLATE OUT. IT WAS FELT THAT 10 X 50 MM CAGE WOULD BE THE APPROPRIATE SIZE. THIS WAS DONE AT L2-3 AND L3-4. THE CAGE WAS FILLED WITH BMP AND GRAFT. IT WAS PLACED AND THEY WERE FELT TO BE IN EXCELLENT POSITION, BOTH AP AND LATERALLY. ON (B)(6) 2014 THE PATIENT UNDERWENT PORTABLE CHEST X-RAY. IMPRESSION: NO ACUTE INFILTRATES OR CONSOLIDATIONS (B)(6) 2014: PATIENT DISCHARGED WITH FOLLOWING DIAGNOSIS: MECHANICAL COMPLICATIONS OF ORTHOPEDIC DEVICE, UNCLASSIFIED. ASSESSMENT: S/P RE-INSTRUMENTATION L1-S1 AND FUSION.
IT WAS REPORTED THAT: ON (B)(6) 2013 THE PATIENT PRESENTED FOR A SCOLIOSIS STUDY TO REASSESS PATIENT'S EXTENSIVE CHANGES OF SPINAL FUSION. IMPRESSION: STABLE CHANGES OF EXTENSIVE THORACOLUMBAR SACROILIAC SPINAL FUSION. ON (B)(6) 2014 PATIENT STATED THIS PAST YEAR HER RODS BROKE AND SHE HAD SURGERY TO FIX THEM. NOW THEY SNAPPED AGAIN. SHE IS HAVING SURGERY AGAIN TO REPLACE THE RODS. ADDISON'S DISEASE (GLUCOCORTOID DEFICIENCY), CANNABIS ABUSE-UNSPEC, CERVICAL DISC W/O MYELPY DSPLCRNNT, LUMBAR DISC W/O MYELPY DSPLCMNT, NEURITIS, LUMBOSACRAL NOS, SCOLIOSIS. ON (B)(6) 2014 THE PATIENT PRESENTED WITH THE PRE OP DIAGNOSIS OF NON UNION. THE RODS WERE BROKEN. THE OLD BRIDGING ROD WAS REMOVED. THE NEW DOMINOS SITES WERE REPAIRED BETWEEN S1 AND ILIAC WING. ON (B)(6) 2014 PATIENT PRESENTED FOR FOLLOW-UP. ON (B)(6) 2015 PATIENT PRESENTED TO OFFICE DUE TO PAIN IN BACK, NECK LEGS AND ARMS. ON (B)(6) 2015 PATIENT PRESENTED FOR NEUROLOGICAL: NUMBNESS, A BURNING SENSATION AND TINGLING. PSYCHIATRIC: ANXIETY. UPPER EXTREMITY: NO SWELLING, TENDERNESS, CREPITATION OR DISCOLORATION. FULL RANGE OF MOTION, SMOOTH, WITHOUT LIMITATIONS. NO LUXATION OR SUBLUXATION. STRENGTH AND TONE: HAND GRIP, WRIST EXTENSION <(>&<)> FLEXION, ARM/SHOULDER ABDUCTION, ELBOW EXTENSION AND FLEXION EQUAL AND SYMMETRIC. BICEPS AND TRICEPS EQUAL AND SYMMETRIC. LOWER EXTREMITY: NO SWELLING, TENDERNESS, CREPITATION OR DISCOLORATION. FULL RANGE OF MOTION, SMOOTH, WITHOUT LIMITATIONS. NO LUXATION OR SUBLUXATION. STRENGTH AND TONE: PERONEAL EVERSION, DORSIFLEXION, PLANTAR FLEXION AND EXTENSION, KNEE FLEXION AND EXTENSION ARE EQUAL AND SYMMETRIC 5/5. ON (B)(6) 2015 PATIENT PRESENTED TO OFFICE FOR FOLLOW-UP. SHE CONTINUED TO EXPERIENCE UPPER BACK PAIN. SCOLIOSIS X-RAYS SHOWED THE INSTRUMENTATION IN GOOD POSITION AS WELL AS THE NEW BRIDGING RODS IN GOOD POSITION AS WELL. ON (B)(6) 2015, (B)(6) 2015 PATIENT PRESENTED FOR FOLLOW-UP STUDY. ON (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015 NURSE TELEPHONE/CONVERSATION NOTE FOR THORACIC BACK PAIN, CHRONIC USE OF OPIATE DRUGS THERAPEUTIC PURPOSES, LOW BACK PAIN, POST-LAMINECTOMY SYNDROME, IDIOPATHIC SCOLIOSIS (AND KYPHOSCOLIOSIS). ON (B)(6) 2015 PATIENT PRESENTED FOR FOLLOW-UP WITH THORACIC BACK PAIN, CHRONIC USE OF OPIATE DRUGS THERAPEUTIC PURPOSES, LOW BACK PAIN, POST-LAMINECTOMY SYNDROME, IDIOPATHIC SCOLIOSIS (AND KYPHOSCOLIOSIS), PHYSICAL EXAM WAS DONE AND HAD THE FOLLOWING RESULT THORACIC SPINE: SURGICAL INCISION WELL HEALED SURGICAL SCAR, BUT WAS CLEAN, DRY AND INTACT. LUMBOSACRAL SPINE: SURGICAL INCISION, WELL HEALED SURGICAL SCAR, BUT WAS CLEAN, DRY AND INTACT. TENDERNESS ON PALPATION OF THE LEFT: PARASPINAL. TENDERNESS ON PALPATION OF THE RIGHT: PARASPINAL. ROM: RANGE OF MOTION IS LIMITED. RANGE OF MOTION INCREASES PAIN. UPPER EXTREMITY: NO SWELLING, TENDERNESS, CREPITATION OR DISCOLORATION. FULL RANGE OF MOTION, SMOOTH, WITHOUT LIMITATIONS. NO LUXATION OR SUBLUXATION. STRENGTH AND TONE: HAND GRIP, WRIST EXTENSION <(>&<)> FLEXION, ARM/SHOULDER ABDUCTION, ELBOW EXTENSION AND FLEXION EQUAL AND SYMMETRIC. BICEPS AND TRICEPS EQUAL AND SYMMETRIC. LOWER EXTREMITY: NO SWELLING, TENDERNESS, CREPITATION OR DISCOLORATION. FULL RANGE OF MOTION, SMOOTH, WITHOUT LIMITATIONS. NO LUXATION OR SUBLUXATION. STRENGTH AND TONE: PERONEAL EVERSION, DORSIFLEXION, PLANTAR FLEXION AND EXTENSION, KNEE FLEXION AND EXTENSION ARE EQUAL AND SYMMETRIC 5/5. PATIENT PAIN COMES AND GOES WAS VERY SEVER, DUE TO PAIN NORMAL SLEEP WAS REDUCED BY LESS THAN 50%, CAN'T SIT AND STAND FOR LONG HOURS AND CAN'T ABLE TO WALK, PAIN IS RAPIDLY WORSENING. ON (B)(6) 2015: PATIENT PRESENTED FOR FOLLOW UP OF NECK PAIN AND LOSS OF ENERGY. PATIENT COMPLAINED OF EXHAUSTING FATIGUE. MUSCULOSKELETAL EXAMINATION SHOWED INCREASED BACK PAIN RODS IN SPINE, LIMITED MOVEMENT, AMBULATION LIMITED, RECENT MVA 3 MONTHS AGO, AGGRAVATING CONDITION. ASSESSMENT: HYPOTHYROIDISM. ASTHMA, UNSPECIFIED, UNSPECIFIED STATUS. ANEMIA. ABNORMAL BLOOD SUGAR.
ON (B)(6) 2005, (B)(6) 2006 PER BILLING RECORDS, THE PATIENT UNDERWENT X-RAYS OF CHEST. (B)(6) 2005 PER BILLING RECORDS, THE PATIENT UNDERWENT X-RAYS OF CHEST, EKG AND CT OF HEAD WITHOUT CONTRAST. ON (B)(6) 2005 PER BILLING RECORDS, THE PATIENT UNDERWENT CARDIAC SONOGRAPH, MRI BRAIN AND MRA HEAD W/O CONTRAST. (B)(6) 2005 PER BILLING RECORDS, THE PATIENT UNDERWENT X-RAYS OF CHEST, EKG (B)(6) 2005 PER BILLING RECORDS, THE PATIENT UNDERWENT CT OF HEAD W/O CONTRAST ON (B)(6) 2005 PER BILLING RECORDS, THE PATIENT UNDERWENT CT OF ABDOMEN AND PELVIS WITH CONTRAST. ON (B)(6) 2006 PER BILLING RECORDS, THE PATIENT UNDERWENT CT OF HEAD AND ANGIO CHEST W/O CONTRAST, CT OF CHEST WITH CONTRAST AND CT OF LOWER EXTREMITY AND ULTRASOUND STUDY. ON (B)(6) 2006 PER BILLING RECORDS, THE PATIENT UNDERWENT ECHOCARDIOGRAPHY. ON (B)(6) 2006 PER BILLING RECORDS, THE PATIENT UNDERWENT CT OF ABDOMEN, PELVIS WITH CONTRAST. ON (B)(6) 2006 PER BILLING RECORDS, THE PATIENT UNDERWENT CT OF ANGIO CHEST W/O CONTRAST, CT OF CHEST WITH CONTRAST AND CT OF LOWER EXTREMITY. ON (B)(6) 2006 PER BILLING RECORDS, THE PATIENT UNDERWENT EKG AND X-RAYS OF THE CHEST. ON (B)(6) 2007 AS PER BILLING RECORDS, THE PATIENT UNDERWENT ULTRASOUND OF CHEST. ON (B)(6) 2007 PER BILLING RECORDS, THE PATIENT UNDERWENT X-RAYS OF CHEST, CT OF ANGIO CHEST W/O CONTRAST, CT OF CHEST WITH CONTRAST, CT OF LOWER EXTREMITY, AND ECHOCARDIOGRAPHY. ON (B)(6) 2007 PER BILLING RECORDS, THE PATIENT UNDERWENT CT LUMBAR SPINE WITH CONTRAST. ON (B)(6) 2009, PATIENT UNDERWENT MRI SCAN OF UPPER SPINAL CANAL. ON (B)(6) 2009, PATIENT UNDERWENT X-RAY OF LOWER AND SACRAL SPINE. (B)(6) 2011 - PER MEDICAL RECORDS, PATIENT PRESENTED FOR A FOLLOW UP. ON (B)(6) 2011 THE PATIENT UNDERWENT X-RAY OF RIGHT AND LEFT HAND, WRIST AND FOOT MINIMUM OF 3 VIEWS, KNEE 3 VIEWS AND X-RAY OF SACROILIAC JOINTS LESS THAN 3 VIEWS. (B)(6) 2012 PATIENT UNDERWENT MRI SCAN OF BRAIN ON (B)(6) 2012 THE PATIENT UNDERWENT THERAPEUTIC EXER CISE TO DEVELOP STRENGTH, ENDURANCE, RANGE OF MOTION, AND FLEXIBILITY ON (B)(6) 2012 THE PATIENT UNDERWENT PHYSICAL THERAPY EVALUATION. ON (B)(6) 2012 THE PATIENT CAME FOR AN EMERGENCY DEPARTMENT VISIT WITH A MODERATELY SEVERE PROBLEM. ON (B)(6) 2012 PER BILLING RECORDS, THE PATIENT UNDERWENT X-RAYS OF THORACIC SPINE REGION. THE PATIENT ALSO PRESENTED FOR FOLLOWUP. ON (B)(6) 2012 THE PATIENT CAME FOR AN OFFICE VISIT. THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE REGION. (B)(6) 2012 - PER MEDICAL RECORDS, PATIENT PRESENTED FOR FOLLOW UP. (B)(6) 2012 - PER MEDICAL RECORDS, PATIENT PRESENTED FOR SOME SUPPORT DEVICE FITTING AND INSERTION. (B)(6) 2013. PATIENT UNDERWENT X-RAY OF MIDDLE AND LOWER SPINE. ON (B)(6) 2013 THE PATIENT CAME FOR AN OFFICE VISIT. THE PATIENT UNDERWENT DRUG SCREEN. (B)(6) 2013: THE PATIENT UNDERWENT X-RAY OF SPINAL REGION. (B)(6) 2013 - PER MEDICAL RECORDS, PATIENT UNDERWENT PATHOLOGY EXAMINATION OF TISSUE USING A MICROSCOPE. (B)(6) 2013: IMPRESSION: STABLE CHANGES OF EXTENSIVE THORACOLUMBAR SACROILIAC SPINAL FUSION. ON (B)(6) 2013 THE PATIENT CAME FOR A POST-OP FOLLOW UP. THE PATIENT UNDERWENT X-RAY OF THORACIC SPINE REGION. (B)(6) 2013 - PER MEDICAL RECORDS, PATIENT PRESENTED FOR FOLLOW UP. (B)(6) 2013: THE PATIENT UNDERWENT X-RAY OF THORACIC SPINE REGION. 17 <(>&<)> (B)(6) 2014 - PER MEDICAL RECORDS, PATIENT PRESENTED FOR X-RAY /CHEST ON (B)(6) 2014 AS PER BILLING RECORDS, THE PATIENT UNDERWENT ELECTROCARDIOGRAM. ON (B)(6) 2014 THE PATIENT CAME FOR AN OFFICE VISIT. (B)(6) 2014 - PER MEDICAL RECORDS, PATIENT PRESENTED FOR A FOLLOW UP. (B)(6) 2014 PATIENT PRESENTED FOR MED. REFILLS. (B)(6) 2014 . ADDISON'S DISEASE (GLUCOCORTOID DEFICIENCY), CANNABIS ABUSE-UNSPEC, CERVICAL DISC W/O MYELPY DSPLCRNNT, LUMBAR DISC W/O MYELPY DSPLCMNT, NEURITIS, LUMBOSACRAL NOS, SCOLIOSIS (B)(6) 2014 THE PATIENT ALSO UNDERWENT X-RAY OF CHEST, 2 VIEWS, FRONT AND SIDE. ON (B)(6) 2014 THE PATIENT CAME FOR AN OFFICE VISIT FOR ASSESSMENT AND MANAGEMENT. (B)(6) 2014 THE RODS WERE BROKEN. THE OLD BRIDGING ROD WAS REMOVED. THE NEW DOMINOS SITES WERE REPAIRED BETWEEN S1 AND ILIAC WING (B)(6) 2014 - PER MEDICAL RECORDS, PATIENT UNDERWENT PATHOLOGY EXAMINATION OF TISSUE USING A MICROSCOPE. ON (B)(6) 2014 THE PATIENT UNDERWENT MRI OF CERVICAL SPINE REGION. (B)(6) 2014 PATIENT PRESENTED FOR FOLLOW-UP. (B)(6) 2015 PATIENT PRESENTED FOR NEUROLOGICAL: NUMBNESS, A BURNING SENSATION AND TINGLING. PSYCHIATRIC: ANXIETY. UPPER EXTREMITY: NO SWELLING, TENDERNESS, CREPITATION OR DISCOLORATION. FULL RANGE OF MOTION, SMOOTH, WITHOUT LIMITATIONS. NO LUXATION OR SUBLUXATION. STRENGTH AND TONE: HAND GRIP, WRIST EXTENSION <(>&<)> FLEXION, ARM/SHOULDER ABDUCTION, ELBOW EXTENSION AND FLEXION EQUAL AND SYMMETRIC. BICEPS AND TRICEPS EQUAL AND SYMMETRIC. LOWER EXTREMITY: NO SWELLING, TENDERNESS, CREPITATION OR DISCOLORATION. FULL RANGE OF MOTION, SMOOTH, WITHOUT LIMITATIONS. NO LUXATION OR SUBLUXATION. STRENGTH AND TONE: PERONEAL EVERSION, DORSIFLEXION, PLANTAR FLEXION AND EXTENSION, KNEE FLEXION AND EXTENSION ARE EQUAL AND SYMMETRIC 5/5. (B)(6) 2015 NURSE TELEPHONE/CONVERSATION NOTE FOR THORACIC BACK PAIN, CHRONIC USE OF OPIATE DRUGS THERAPEUTIC PURPOSES, LOW BACK PAIN, POST-LAMINECTOMY SYNDROME, IDIOPATHIC SCOLIOSIS (AND KYPHOSCOLIOSIS) (B)(6) 2015 PATIENT PRESENTED TO OFFICE FOR FOLLOW-UP. SHE CONTINUED TO EXPERIENCE UPPER BACK PAIN. SCOLIOSIS X-RAYS SHOWED THE INSTRUMENTATION IN GOOD POSITION AS WELL AS THE NEW BRIDGING RODS IN GOOD POSITION AS WELL. (B)(6) 2015 PATIENT PRESENTED FOR FOLLOW-UP STUDY. (B)(6) 2015, PER MEDICAL RECORDS, PATIENT PRESENTED FOR A FOLLOW UP. ON (B)(6) 2015 PER BILLING RECORDS, THE PATIENT UNDERWENT DX X-RAY/CHEST. (B)(6) 2015 PATIENT PRESENTED FOR FOLLOW-UP WITH THORACIC BACK PAIN, CHRONIC USE OF OPIATE DRUGS THERAPEUTIC PURPOSES, LOW BACK PAIN, POST-LAMINECTOMY SYNDROME, IDIOPATHIC SCOLIOSIS (AND KYPHOSCOLIOSIS), PHYSICAL EXAM WAS DONE AND HAD THE FOLLOWING RESULT THORACIC SPINE: SURGICAL INCISION WELL HEALED SURGICAL SCAR, BUT WAS CLEAN, DRY AND INTACT. LUMBOSACRAL SPINE: SURGICAL INCISION, WELL HEALED SURGICAL SCAR, BUT WAS CLEAN, DRY AND INTACT. TENDERNESS ON PALPATION OF THE LEFT: PARASPINAL. TENDERNESS ON PALPATION OF THE RIGHT: PARASPINAL. ROM: RANGE OF MOTION IS LIMITED. RANGE OF MOTION INCREASES PAIN. UPPER EXTREMITY: NO SWELLING, TENDERNESS, CREPITATION OR DISCOLORATION. FULL RANGE OF MOTION, SMOOTH, WITHOUT LIMITATIONS. NO LUXATION OR SUBLUXATION. STRENGTH AND TONE: HAND GRIP, WRIST EXTENSION <(>&<)> FLEXION, ARM/SHOULDER ABDUCTION, ELBOW EXTENSION AND FLEXION EQUAL AND SYMMETRIC. BICEPS AND TRICEPS EQUAL AND SYMMETRIC. LOWER EXTREMITY: NO SWELLING, TENDERNESS, CREPITATION OR DISCOLORATION. FULL RANGE OF MOTION, SMOOTH, WITHOUT LIMITATIONS. NO LUXATION OR SUBLUXATION. STRENGTH AND TONE: PERONEAL EVERSION, DORSIFLEXION, PLANTAR FLEXION AND EXTENSION, KNEE FLEXION AND EXTENSION ARE EQUAL AND SYMMETRIC 5/5. PATIENT PAIN COMES AND GOES WAS VERY SEVER, DUE TO PAIN NORMAL SLEEP WAS REDUCED BY LESS THAN 50%, CAN'T SIT AND STAND FOR LONG HOURS AND CAN'T ABLE TO WALK, PAIN IS RAPIDLY WORSENING. (B)(6) 2015, PER MEDICAL RECORDS, PATIENT PRESENTED FOR A FOLLOW UP. ON (B)(6) 2015 PER BILLING RECORDS, THE PATIENT UNDERWENT CT SCAN OF HEAD.
IT WAS REPORTED THAT ON: (B)(6) 2009: AS PER THE BILLING RECORDS, THE PATIENT PRESENTED FOR AN OFFICE VISIT. ON (B)(6) 2012: PATIENT PRESENTED WITH COMPLAINT OF CHRONIC ANXIETY, EPISODIC DEPRESSION, FREQUENT LOW ENERGY, FLUCTUATING SLEEP DISTURBANCE, AGORAPHOBIA AND CHRONIC STRESS. DIAGNOSIS: DEGENERATIVE DISK DISEASE; FIBROMYALGIA; ADDISON'S DISEASE. ON (B)(6) 2012: PATIENT PRESENTED WITH COMPLAINT OF DEPRESSION, ANXIETY, PANIC ATTACKS AND INSOMNIA AND UNDERWENT PSYCHIATRIC INITIAL EVALUATION. ON (B)(6) 2013: PATIENT PRESENTED FOR SUPPORTIVE PSYCHOTHERAPY, MEDICATION MONITORING AND MEDICATION TEACHING. PATIENT HAD DIAGNOSIS OF MAJOR DEPRESSIVE DISORDER AND GENERALIZED ANXIETY DISORDER. ON (B)(6) 2013, (B)(6) 2014: PATIENT PRESENTED FOR A PSYCHIATRIC FOLLOW-UP. ASSESSMENT: MAJOR DEPRESSIVE DISORDER, RECURRENT, MODERATE; GENERALIZED ANXIETY DISORDER. ON (B)(6) 2014: PATIENT PRESENTED FOR A PSYCHIATRIC FOLLOW-UP. ASSESSMENT: MAJOR DEPRESSIVE DISORDER, RECURRENT, MODERATE; GENERALIZED ANXIETY DISORDER. ON (B)(6) 2014: PATIENT PRESENTED WITH COMPLAINT OF BEING HIGHLY STRESSED BECAUSE OF BROKEN RODS IN HER BACK FOR WHICH SHE MIGHT HAVE TO GO ANOTHER BACK SURGERY. ON (B)(6) 2015 THE PATIENT UNDERWENT X-RAYS OF THE SHOULDER. IMPRESSION: CALCIFIC TENDINOSIS OF THE ROTATOR CUFF. MODERATE DEGENERATIVE CHANGES OF THE ACROMIOCLAVICULAR JOINT. ON (B)(6) 2015 PER BILLING RECORDS, THE PATIENT UNDERWENT CT SCAN OF HEAD. IMPRESSION: NO HEMORRHAGE, MIDLINE SHIFT OD OTHER SIGNIFICANT MASS EFFECT. ON (B)(6) 2016: THE PATIENT PRESENTED FOR AN OFFICE VISIT FOR FOLLOW-UP, WITH COMPLAINT OF BACK PAIN AND FOR MEDICATION REFILL. ON (B)(6) 2016: THE PATIENT PRESENTED FOR FOLLOW-UP. ASSESSMENT: HYPOTHYROIDISM. HTN (HYPERTENSION). COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE). DEPRESSION WITH ANXIETY. SEIZURE DISORDER. OTHER ABNORMAL GLUCOSE. BACK PAIN. ON (B)(6) 2016: THE PATIENT PRESENTED FOR AN OFFICE VISIT WITH CHIEF COMPLAINTS OF COUGH, UP DARK GREEN PHLEGM, HEAD AND SINUS CONGESTION, CHEST CONGESTION, PROBLEMS WITH EYES. THE PATIENT FELL IN GRASS IN FRONT OF HOUSE, HAD BRUISE ON LEFT LEG. THE PATIENT ALSO HAD AN ATTACK FROM ADDISON'S DISEASE FEW DAYS AGO.
THE PATIENT'S INITIAL SURGERY WAS POSTEROLATERAL T3-PELVIS WITH A TLIF AT L4-5 AND L5-S1. AT 9 MONTHS POST-OP THE PATIENT UNDERWENT ADDITIONAL SURGERY DUE TO ROD BREAKAGE AT BILATERALLY AT L3-4. THE REVISION INVOLVED A "BRIDGING" TECHNIQUE AND NO HARDWARE WAS EXPLANTED. AT LEAST TWO LEVELS WERE BRIDGED AND INTER-BODY DEVICES WERE IMPLANTED AT L2-L4. THE ORIGINAL CONSTRUCT BROKE AGAIN, POSSIBLY JUST ABOVE AND JUST BELOW THE "BRIDGING" REPAIR AND A SECOND REVISION SURGERY WAS DONE APPROXIMATELY 18 MONTHS POST-OP. AS IN THE FIRST REVISION, NO HARDWARE WAS EXPLANTED AND THE SURGEON UTILIZED A "BRIDGING" TECHNIQUE.
IT WAS REPORTED THAT: ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT. REVIEW OF SYSTEMS REVEALS THAT PATIENT IS POSITIVE FOR JOINT PAIN, JOINT SWELLING, DRY MOUTH, ALOPECIA, SHORTNESS OF BREATH, MYALGIA, BLOOD CLOTS AND FATIGUE. IMPRESSION: COPD, CHRONIC PAIN. ON (B)(6) 2011 PATIENT UNDERWENT X-RAY OF BILATERAL KNEES. IMPRESSION: 1) DEGENERATIVE CHANGES SEEN IN THE HANDS , KNEES AND FEET. 2) SCATTERED CYSTIC DENSITIES IN THE HANDS, WRISTS AND FEET BILATERALLY. THIS CAN BE SEEN IN RHEUMATOID ARTHRITIS IN THE APPROPRIATE CLINICAL SETTING. 3) FINDINGS CONSISTENT WITH SACROILITIS, MORE PROMINENT ON THE RIGHT THAN ON THE LEFT. ON (B)(6) 2012:PATIENT PRESENTED FOR CONSULTATION FOR INCREASED FATIGUE, BACK PAIN, LEG WEAKNESS AND RECENT FALLS. RECENT LABORATORY RESULTS DEMONSTRATED A SLIGHTLY ELEVATED ESR AND RHEUMATOID FACTOR, HOWEVER THESE ARE NOT INDICATIVE OF A CONNECTIVE TISSUE DISORDER. AFTER 2 EXAMS AND ASSESSMENT OF RADIOLOGIC IMAGING IT IS BELIEVED THAT 1) FIBROMYALGIA IS THE PRIMARY CAUSE OF HER PAIN. 2) LOWER EXTREMITY PAIN SECONDARY TO FIBROMYALGIA AND DECONDITIONING CONTRIBUTING TO FALLS. 3) MILD/ MODERATE RADICULOPATHY AS PER MRI'S AND EMG'S. 4) MILD ELEVATION OF ESR AND RF, NOT INDICATIVE OF A CONNECTIVE TISSUE DISORDER AT THIS TIME.
IT WAS REPORTED THAT: (B)(6) 2008 THE PATIENT UNDERWENT CT SCAN OF LUMBAR SACRAL SPINE. IMPRESSION: MILD BROAD-BASED DISC PROTRUSION AT L5-S1 CREATING A MILD CENTRAL AND MILD BILATERAL NEURAL FORAMINAL STENOSIS. REMAINING LEVELS ARE UNREMARKABLE. ON (B)(6) 2015 PER BILLING RECORDS, THE PATIENT UNDERWENT DX X-RAY/CHEST AND OF SPINE OF NECK .IMPRESSION: NO FRACTURE MISALIGNMENT OR SIGNIFICANT CENTRAL STENOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 752370 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR | Other| R |