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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Pain (1994); Seroma (2069); Swelling (2091); Weakness (2145); Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a two stage-spinal fusion, first stage surgery occured on (b)(6) 2011 and second stage on (b)(6) 2011.During the planned second stage, surgeon performed a posterior interbody arthrodesis at l3-l4 using rhbmp-2/acs with a 14 mm cage, autograft, nanoss and matrix.Also during (b)(6) 2011 surgery, arthrodesis from c7-s1 was completed.After a number of rods were contoured and fixed to screws in the patient's spine, bone grafting was performed at c7 to t6 and t12 to l1.This bone grafting was achieved with a combination of "local bone, beta tricalcium phosphate and bone morphogenic protein placed directly over the exposed decorticated surfaces bridging the area." subsequently, patient has never recovered from this 2 stage spinal surgery, and continues to suffer from daily severe and disabling pain in her back, weakness in her upper extremities, abnormal bone growth, a large swelling at the cervicothoracic spine, and the appearance of solid nodules of unknown etiology in her lungs.
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Manufacturer Narrative
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(b)(6).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.
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Manufacturer Narrative
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(b)(4).
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Event Description
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On (b)(6) 2010: the patient underwent cervical and thoracic mris.Assessments: severe thoracolumbar scoliosis, status post scoliosis correction and multiple surgeries with mid thoracic disk-sacral fusion; radiating right arm pain, markedly improved after medrol dosepak; urinary and bowel incontinence and imbalance, mildly improved; thoracic disk herniation.On (b)(6) 2010: the patient underwent chest 2v pa or ap <(>&<)> lat.Impression: no acute cardiopulmonary disease.On (b)(6) 2010, reportedly, the patient presented with the preoperative diagnosis of thoracic disk herniation, thoracic kyphosis and thoracic myelopathy.The patient underwent surgery which consisted of: fusion from t3-l4 with t8-t9 and t9-ti0 laminectomies and osteotomy t8-t9, t9-t10.Reportedly there were problems on the patient awaking in the recovery area.They had upper extremity weakness with lower extremities intact and radiating right arm pain.The patient also underwent film cxr.Impression: the distal tip of the right-sided central venous catheter is projected over the central superior vena cava.Posterior thoracic spine fusion rods and transpedicular screws.Skin staples.The patient also underwent an mri for neck pain, numbness and grip loss on both upper extremities.On (b)(6) 2010: the patient underwent mri cervical spine w/o cm for neck pain and upper extremity numbness.Impression: moderately severe diffuse chronic degenerative discopathy cervical spondylosis with multilevel dorsal disk spur complexes compressing the thecal sac.Multilevel dorsal impingement on the thecal sac related to hypertrophy the ligamentum flavum.No central stenosis.No cord compression syrinx or edema.Asymmetric osteophytic narrowing of the neural foramina at various levels.Osteophytic narrowing at c5-6 on the right side may compromise the exiting right c6 nerve root.There is a small right paramedian dorsal disk herniation at this level of the indeterminate chronicity.No fracture bony destructive change.Harrington rod artifacts noted over the posterior visualized upper dorsal spine.On (b)(6) 2010: the patient underwent x-rays for the spine entire ap and lat.Impression: scoliosis study.Posterior thoracolumbar rods with the pedicle screw fixation.On (b)(6) 2010: the patient underwent x-rays for the spine entire ap and lat.Impression: postop unchanged status post instrumented fusion.No evidence of hardware failure or migration.On (b)(6) 2010: the patient underwent the us abd survey ltd or ruq procedure for right upper quadrant pain r/o cholecystitis.Impression: unremarkable right upper quadrant sonogram.The patient also underwent x-rays examination of chest owing to pain baseline.Impression: negative.The patient also had to undergo us ruq for nausea and cholecystitis.Impression: the sonographic murphy's sign was negative.The common duct was borderline prominent at 0.6 cm.No wall thickening or pericholecystic fluid.The liver was prominent at 19 cm.No focal lesions.No free fluid.Visualized portions of the pancreas and aorta within normal limits.Normal right kidney.The patient was admitted to the emergency department.Impression: intractable back pain.Persistent severe nausea.On (b)(6) 2010: the patient was admitted to the health center with the following diagnoses: severe thoracolumbar scoliosis, status post multiple surgeries with mid thoracic disk sacral fusion; radiating right arm pain, markedly improved with medrol dosepak; urinary and bowel incontinence and imbalance, mildly improved; thoracic disk herniation.The patient underwent t3 to l4 posterior spinal fusion with instrumentation, t8 to t10 osteotomy with decompression.
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Event Description
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On (b)(6) 2009, per billing records, the patient underwent a scoliosis study.On (b)(6) 2009, per billing records, the patient presented in er and underwent various labs including but not limited to a cbc, urinalysis, and prothrombin.The patient underwent a ct of the lumbar and thoracic spine and a mri of the thoracic spine.On (b)(6) 2009, per billing records, the patient underwent a thoracic spine mri.On (b)(6) 2009, per billing records, the patient underwent various labs including but not limited to a cbc, urinalysis, and prothrombin on (b)(6) 2010 the patient, reportedly, was injured.On (b)(6) 2012 the patient presented with shoulder and scapular pain.The patient underwent a mri of the-bilateral brachial plexus which demonstrated postoperative changes at c7-t2.There was mild postoperative edema involving the soft tissues.There was no evidence of fluid collection.There was a mild atrophy of the deltoid, trapezius, supraspinatus muscles right greater than left.Given the lack of muscular edema, the atrophy most likely reflected dis-use atrophy.Also noted was a left thyroid nodule, measures 1.5 cm.R on (b)(6) 2012 the patient presented with myelopathy and underwent a biopsy.A pathology tissue exam was conducted of the serratus anterior left and upper trapezius left.Results type ii slight atrophy of the upper trapezius and some minor non-specific myopathic abnormalities.On (b)(6) 2012 the patient presented with shoulder pain, significant dysfunction of the shoulders and arms with atrophy of the muscles, weakness, and the inability to raise arm up.The patient stated their shoulder blades were not in place.The bilateral shoulder girdles showed atrophy of the trapezius, deltoids.The patient also had a muscle biopsy done which showed disuse atrophy.Apparently her emg neurologic studies have not shown significant findings for the shoulder musculature.A mri that was done of the bilateral brachial plexus which showed no definitive masses in the plexus.On (b)(6) 2012 the patient presented with shoulder pain.Per the encounter notes the patient had undergone some form of trapezius dehiscence surgery 2 months prior.The patient felt both shoulders hung down and that they had had weight over the top of both shoulders.Between (b)(6) 2012 and (b)(6) 2012 the patient participated in physical therapy approx.2 x a week and presented with significant de-conditioned status throughout all core and scapular stabilizing muscles leading to significant muscular skeletal imbalance.The patient complained of pain, fatigue, the inability to sit straight without support, occasional ripping /tearing sensation in shoulder, aching in the right arm, difficulty walking, and limited rom of shoulder.Diagnosis: lumbago.On (b)(6) 2012 in a fax the patient reported presented shoulder pain/ calcification.Per the fax notes, the patient reported increased pain and trouble in the left upper shoulder.On (b)(6) 2012, in a telephone encounter, the patent presented primarily trapezial area pain, upper extremity paresthesias, and difficulty with movement in the upper extremities as well as generalized fatigue and endurance challenge.On (b)(6) 2012 the patent reported lack of progress in regard to treatment and recovery.On (b)(6) 2012 the patent reported they were continuing to experience stumbling and falls.On (b)(6) 2012 the patent reported having fallen over the weekend.The patient reported that they had felt a "weird tightness" in the left upper traps area before they started to get off balance.They also had had increased episodes of incontinence.On (b)(6) 2013 the patient presented with limited/no function of the shoulder girdle muscles and increased tightness and tension through upper traps.The patient also reported the inability to walk well, feeling very deconditioned, pain, limited rom of the shoulder, and fatigue.On (b)(6) 2009 the patient presented with thoracic myelopathy and underwent spinal x-rays which showed mild s-shaped scoliosis of the lumbar and thoracic spine, previous multi-level lumbar fusion with solid-appearing right-sided graft and moderate thoracic kyphosis.It should be noted that the study was very limited by technique.On (b)(6) 2009 the patient presented with scoliosis and underwent a standing spine xr scoliosis study which revealed mild s-shaped t horacolumbar scoliosis and thoracic kyphosis.The bones appeared demineralized.The vertebrae were difficult to evaluate, given the degree of osteoporosis and the patient's body habitus.There appeared to be multilevel ankylosis of the lumbar spine.There were no significant changes from the last study (b)(6) 2009.On (b)(6) 2009 the patient presented in er with decreased sensation in the right lower extremities with numbness and an increase in back pain.Per the encounter notes the patient had recently been diagnosed with a spinal cord compression and thoracic disc herniation at t10.The patient reported increased stool and urinary incontinence.The patient also complained of saddle anesthesia.The patient was admitted for surgical evaluation (t9-10 decompression and possible fusion extension) and treatment.The patient was positive for a urinary tract infection (uti).An ekg was run which was normal.White blood count (wbc) was 5.8 otherwise unremarkable.The patient also underwent a thoracic spine ct which demonstrated no evidence of fracture or mal-alignment on the lateral view.Spinal canal dimensions were capacious.There was significant mid thoracic degenerative change, particularly t7 through t10.Fusion through lumbar spine to t10 appeared solid.There were changes of transition syndrome with slightly widened facet joints at the t9-10 level with no evidence of gross mal-alignment.A mri showed a small lower thoracic syrinx of uncertain clinical significance.No change over the past two and one-half months.On (b)(6) 2009 the patient was discharged from hospital.The patient was to wear a hard brace on their torso.On (b)(6) 2009 the patient presented by ambulance to the er and was admitted to hospital with increasing back pain, increased weakness, urinary and bowel incontinence with abdominal cramping (often with the inability to feel they needed to go), numbness in both extremities, difficulty ambulating, and muscle cramps.Past medical history (pmh) listed as: spinal cord compression, scoliosis, thoracic myelopathy, and papillary necrosis, and hypertension.The patient underwent an mri which demonstrated no significant change since (b)(6) 2009, moderate mid-lower thoracic levoscoliosis, solid posterior multi-segment thoracolumbar fusion, multilevel degenerative disc disease with small focci posterior disc protrusions, and mild distal thoracic cord atrophy and hydromyelia.The mri was positive for a syrinx in the lower aspect of the thoracic spine, multi-level degenerative disc disease, disc herniations at t9-10, t8-9, and t7-8.Assessment: thoracic myelopathy, thoracic herniated disc, and mild to moderate stenosis.Acute cauda equina syndrome was ruled out.The patient was noted to be on large doses of medication to control their pain.The patient also was found to have leukocytosis, which was very likely attributed to margination of the neutrophil as a result of the large intake of dexamethasone.The patient was also found to have steroid-induced hyperglycemia without any symptoms of diabetes mellitus controlled with insulin-sliding scale noyolog.In a (b)(6) 2009 consultation the patient presented with an increase in extremity weakness, incontinence, and a thoracic herniated nucleus polyposis with t-spine syrinx.Glucose levels were abnormal.On (b)(6) 2009 the patient was discharged from hospital.On (b)(6) 2009 it was planned that the patient would undergo surgery on (b)(6) 2009 that consisted of a t2-t4 posterior spinal fusion with instrumentation; a t8-t10 osteotomy, and possible transpedicular decompression and interbody fusion t8-t10.On (b)(6) 2010 the patient presented with scoliosis and underwent lumbar spine x-rays which demonstrated bone demineralization, thoracolumbar scoliosis (approx.18 degrees), and degenerative disc disease.On (b)(6) 2010 the patient presented for pre-op chest x-rays which showed no significant pulmonary abnormalities.There was osteopenia of the bones, dextroscoliosis of the mid-thoracic spine, associate degenerative change and mild kyphosis of the thoracic spine.On (b)(6) 2010 the patient underwent thoracolumbar fusion surgery utilizing fluoroscopic imaging for placement and alignment of inst rumentation.Chest x-rays for the central line placement were negative.On (b)(6) 2010 the patient presented with neck pain and upper extremity numbness.The patient underwent a cervical spine mri which demonstrated moderately severe diffuse chronic degenerative discopathic cervical spondylosis with multilevel dorsal disk spur complexes compressing the thecal sac.There was multilevel dorsal impingement on the thecal sac related to hypertrophy of the ligamentum flavum.There was no central stenosis and no cord compression, syrinx or edema.There was asymmetric osteophytic narrowing of the neural foramina at various levels.There was osteophytic narrowing at c5-6 on the right side may compromise the exiting right c6 nerve root.There was a small right paramedian dorsal disk herniation at c5-6of indeterminate chronicity.There was no fracture bony destructive change.Harrington rod artifacts were noted over the posterior visualized upper dorsal spine.On (b)(6) 2010 the patient presented with scoliosis and underwent x-rays which showed posterior thoraco- lumbar rods.Proximal rod tips were at the l2 level, and distal rod tips the l5 level.Multiple paired pedicle screws at the lumbar vertebral levels thoracic vertebral levels were present.There was a ventriculo-peritoneal shunt catheter noted on the right.On (b)(6) 2010 the patient presented, post op, for a spine x-ray which showed no evidence of hardware failure or migration.On (b)(6) 2010 the patient presented with right upper quadrant pain r/o cholecystitis.The patient underwent an abdomen sonogram which was unremarkable.The patient underwent a chest x-ray which was negative.On (b)(6) 2010 the patient presented with scoliosis and underwent spine x-rays which showed postsurgical changes were redemonstrated with spinal rods in place from approximately t3-l4.Pedicle screws were in place at each level except for t11.The bones were osteopenic.Scattered degenerative changes were seen.Surgical clips overlaid the lumbosacral junction.Surgical drain and posterior skin staples had been removed.Thoracolumbar levoscoliosis measured approximately 33 degrees.On (b)(6) 2011, per billing records, in a pre-operative examination, the patient presented with cervical spondylosis with myelopathy, low back pain, and closed lumbar vertebra fracture.On (b)(6) 2011, per billing records, the patient presented with low back pain, lumbar fracture, kyphosis/scoliosis, and respiratory failure.On (b)(6) 2011, per billing records, in a post op f/u, the patient presented with kyphosis/scoliosis.On (b)(6) 2011, per billing records, in a post op f/u, the patient presented with hematuria.On (b)(6) 2011, per billing records the patient presented with hypocalcaemia.On (b)(6) 2011, per billing records the patient presented with low back pain.On (b)(6) 2011, per billing records the patient presented with pain in thoracic spine, syncope and collapse.On (b)(6) 2011, per billing records the patient presented with spasmodic torticollis and pain in the thoracic spine.On (b)(6) 2012, per billing records the patient presented with urge incontinence and a urinary tract infection on (b)(6) 2012, per billing records, the patient presented with urge incontinence.On (b)(6) 2012, per billing records, the patient presented with a urinary tract infection.On (b)(6) 2012, per billing records, the patient presented with nausea with vomiting.On (b)(6) 2012, per billing records, the patient presented with cervicalgia, myalgia and myositis.On (b)(6) 2013, per billing records, the patient presented with chronic sinusitis.
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Manufacturer Narrative
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Additional information: review of radiographic images found as follows: (b)(6) 2010 spine series very poor quality films.Thoracic lateral appears to show degenerative changes without fracture.Moderate increased kyphosis noted.Entire spine ap shows mid thoracic apex right scoliosis and lateral lumbar shows osteopenia with evidence of posterior element fusion that is difficult to determine due to fusion surgery or congenital deformity.Anterior clips are seen from l4 to overlying the sacrum.On (b)(6) 2010, lateral scoliosis film again of very poor quality shows no instrumentation, exaggerated kyphosis through the thoracic spine and apparent fused posterior elements.On (b)(6) 2010, pa and lateral chest films show mature breast development, heart of normal size and contour, exaggerated thoracic kyphosis centered at about t8.On (b)(6) 2010, multiple interoperative films during fusion surgery show segmental pedicle screw placement from about t3 to about l4 with bilateral rods.On (b)(6) 2010, ct scan cervical shows apparent cervical hnp at c5/6 on the right.Numberous sagittal and axial views are obtained, most of very poor quality.On (b)(6) 2010, ap views of upper and lower spine show construct in place t3 to l4 with brace on and in place.On (b)(6) 2010, ap and lateral entire spine shows construct without change.On (b)(6) 2010, ap chest film shows contruct in place without change.Lung fields and heart show normal profiles.On (b)(6) 2010, complete spine ap appears to show the thoracic spine a bit more out of coronal balance to the right.
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Event Description
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On (b)(6) 2007, the patient underwent echocardiogram for evaluation of chest pain.Impression: mild left ventricular hypertrophy with normal systolic function, ejection fraction 66%; other wise normal appearing echo.On (b)(6) 2009, the patient underwent xr spine scoliosis standing.Impression: mild s-shaped scoliosis noted; previous multi-level lumbar fusion with solid-appearing right-sided graft.On (b)(6) 2009, per billing records, the patient underwent a scoliosis study.The patient underwent xr spine scoliosis standing.Impression: no change compared to xr on (b)(6).On (b)(6) 2009, the patient presented with complaining of right lower extremity numbness and difficulty ambulating.Assessment: right lower extremity hypoesthesia and persistent and stable bowel and bladder incontinence; hypertension, continue lopressor; fluid electrolyte nutrition; history of thoracic myelopathy, status post sacral thoracic fusion; deep venous thrombosis and gastrointestinal prophylaxis with lovenox and protonix; positive urinalysis.The patient underwent ct of spine thoracic w/o contrast for injury spinal cord site.Impression: no evidence of fracture or malalignment on the lateral view.Spinal canal dimensions are capacious; significant mid thoracic degenerative change, particularly t through t10; fusion through the lumbar spine up to t10, which appears solid.The patient underwent ct lumbar spine without contrast.Impression: solid bony fusion from the sacrum to t10; capacious spinal canal without evidence of significant canal or neural foraminal narrowing; access for a myelogram might be accomplished at the l4 level.The patient underwent mri of thoracic spine due to injury spinal cord site.Impression: small lower thoracic syrinx of uncertain clinical significance.On 29 oct 2009, impression: severe weakness in both lower extremities progressing from previous admission with bowel and bladder incontinence; no significant changes in mri; hypertension; patient has significant leukocytosis; patient also has hyperglycemia; acute back pain with subjective motor weakness and incontinence of unclear etiology.The patient underwent mri of thoracic spine w/ + w/o contrast for scoliosis, back pain , gait disturbance and incontinence.Impression: moderate mid lower thoracic levoscoliosis; solid posterior multi-segment thoracolumbar fusion; multilevel degenerative disc disease with small focal posterior disc protrusions; mild distal thoracic cord atrophy and hydromyelia.On (b)(6) 2009, the patient presented with er for pain control, increased episodes of incontinence, increased abdominal cramping, and increased extremity weakness.Assessment: thoracic myelopathy, thoracic herniated nucleus pulposus, t10 to s1 fusion, mild to moderated canal stenosis.On (b)(6) 2009, the patient underwent mri of the thoracic spine.The patient had these symptoms possibly caused by kyphosis noted in her spine.On (b)(6) 2011: the patient presented with the following preoperative diagnoses: l4 fracture; thoracic hyperkyphosis; status post t3-l4 posterior spinal arthrodesis and fixation.The patient underwent the following procedures: removal of posterior spinal fixation, t3-l4; insertion of bilateral pelvic fixation; exploration of posterior spinal arthrodesis t3-s1; three column osteotomy, l4/pedicle subtraction osteotomy; laminectomy l3 and l5; neurophysiologic testing bilateral pedicle screws c7-s1; harvest of iliac crest bone graft through separate skin and fascial incision; application of cranial tongs, including removal; open treatment l4 fracture; laminotomy right c6-7.Stryker and oasis hardware was implanted.No patient complications were noted.On (b)(6) 2011 : the patient presented with the following preoperative diagnoses: fracture t3; cervicothoracic myelopathy; back pain.The patient underwent the following procedures: posterior spinal arthrodesis c7-s1; open treatment t3 fracture; posterior and posterolateral osteotomy t2; laminectomy t3; posterior interbody discectomy and arthrodesis l3-4; application/insertion of intervertebral biomechanical device l3-4; revision/re-exploration laminoforaminotomies, bilateral l3-4; application and removal of cranial tongs; harvest and application of local autograft bone; re-insertion spinal fixation t4-l3; posterior segmental spinal fixation c7-t4 and l3-s1/pelvis.Stryker and nanoss and nuvasive hardware implanted.Per the op notes, arthrodesis was completed from c7-s1 utilizing a high speed cutting bur, local and iliac crest bone graft, followed by placement of biologic extenders including rhbmp-2/acs collagen sponge, nanoss, and grafton matrix.Per the co-surgeon's notes, bone grafting was then performed after decortication of the cervical and thoracic spine from c7 down to approximately t6, posterior allografting was then performed using a combination of local bone, beta tricalcium phosphate and rhbmp-2/acs placed directly over the exposed decorticated surfaces bridging the area.Similar grafting procedure was then performed on the lumbar spine from approximately the fusion mass of the lumbosacral junction up into the upper lumbar spine at approximately t12-l1.No patient complications were noted.
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Manufacturer Narrative
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Review of radiographic images found as follows: a single view, an ap scoliosis view is provided in the negative.The instrumentation appears to extend from approximately t3 to l5.There is nothing else that can be determined from this film.
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Event Description
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On (b)(6) 2001 the patient complained of low back pain and recent kidney infection.On (b)(6) 2001 the patient presented for cytopathological test (urine specimen).Final diagnosis: no atypical or malignant cells.On (b)(6) 2002 the patient's thoracic and lumbar films were obtained.Her fusion appeared solid from the mid-thoracic spine to the sacrum.There was no significant widening or arthritis noted on these films on her si joint (ap/pelvis was not obtained).She has sclerosis across the mid-thoracic vertebrae approximately t7 or 8 with approximately 10 degree kyphosis at that one level.Her spine was relatively straight; however, the take-off from the pelvis was approximately 10 degrees toward the right.She had a flat-back deformity with loss of lumbar lordosis on lateral films.There was no gross instability on flexion/extension lateral films.The patient also underwent ct of the soft neck due to pressure in neck.Impression: 1.Left maxillary sinus disease.2.Bilateral multiple thyroid nodules.On (b)(6) 2002 the patient underwent mri of the thoracic spine for spinal stenosis.Impression: imaged portions of the thoracic spine are patent.A posterior bony fusion is present from t10 more caudad.The distal portion of the fusion was not imaged on this examination.On (b)(6) 2002 the patient presented with problems with her spine.The patient reported having sharp/dull/ache constant pain in leg and injured elbow.The patient underwent ct scan of the lower extremity without contrast for right hip pain.Impression: degenerative enthesopathy of the greater trochanter.No fracture identified in the right hip.The patient also underwent x rays of the spine lumbosacral ap & lat due to right hip and back pain.Impression: lumbar spine fusion.No evidence of acute fracture or dislocation.On (b)(6) 2002 the patient underwent x-rays of the foot cmpl for pain and swelling.Impression: mild osteoarthritic changes first mtp joint.On (b)(6) 2002 the patient presented with shortness of breath.The patient complained of feeling tightness in throat -lump in throat.The patient underwent x-rays of the neck, soft tissue/thornton.Impression: 1.No evidence of airway narrowing.2.Degenerative change at the c5-6 level.On (b)(6) 2002 the patient presented with tightness in the throat.On (b)(6) 2003 the patient presented with complaint of left arm pain.The patient underwent x-rays of cervical spine due to severe neck pain which revealed multilevel degenerative changes accompanied with scoliosis.There was cervical kyphosis.The most degenerative disk was at c5-6.Impression: 1.Cervical stenosis and/or disk herniation, 2.Severe left radiating arm pain.On (b)(6) 2003 the patient complained of neck and arm pain.On (b)(6) 2003 the patient underwent mri of the cervical spine due to cervicalgia.Impression: multilevel neural foraminal stenosis and central canal stenosis at the c3-4 and c5-6 intervertebral body levels, as described.On (b)(6) 2003 the patient underwent mri of cervical spine due to left-sided arm pain, which demonstrated multilevel neural foraminal stenosis and central stenosis at the c3-4 and c5-6 intervertebral body levels.On (b)(6) 2003 the patient underwent mri which demonstrated multilevel cervical spondylosis and neck & radiating arm pain.On (b)(6) 2003 the patient complained of arm pain.On (b)(6) 2003 the patient underwent ct scan of the abdominal renal st due to flank pain.Impression: 1.Proximal left periureteral stranding suggestive of inflammation without evidence of a ureteral stone.If pyelonephritis is a clinical concern, a contrast ct is recommended for better evaluation.2.Focal calcification within the posterior aspect of a left upper pole calix, possibly representing calcium within a caliceal diverticulum versus nephrolithiasis.3.Status post thoracolumbar bone grafting.On 4 (b)(6) 2003 the patient complained of flank pain.On (b)(6) 2003 the patient underwent ultrasound study of the abdomen due to right upper quadrant abdominal pain.Impression: 1.Mild hepatomegaly.2.No other cause found for right upper quadrant pain.On (b)(6) 2003 the patient complained of kidney infection/weakness and vomiting.The patient underwent ct scan of the abdominal renal st due to flank pain.Impression: 1.Interval resolution of the previously noted left periureteral stranding with a single focus of increased density in the left mid kidney, unchanged from the prior examination.On (b)(6) 2003 the patient complained of urinary tract symptoms with bleeding.On (b)(6) 2004, in a telephone encounter, the patient stated severe pain in left side due to kidney infections.The patient underwent ct scan of the abdominal renal st due to left flank pain.Impression: overall, no significant change in the study when compared to the previous examination.In 2008, the patient suffered a fall at work and patient underwent extensive workup between 2008 and 2009.In 2009, the patient underwent t8 compression with fusion from t3 to l4 with rods.On (b)(6) 2010 the patient underwent thoracic ct scan, which demonstrated spinal fusion t2 through t10.Hardware was intact with good alignment.No evidence for hardware loosening.On (b)(6) 2010 the patient reportedly underwent a cervical cancer screening.(b)(6) 2010: the patient presented with midback and leg symptoms including pain in lower ribs bilaterally and increased kyphosis in midthoracic spine on (b)(6) 2010, the patient was examined for status post extensive back surgery for scoliosis.Final impression: the patient appeared stable postoperatively except for hypertension.On (b)(6) 2010 the patient presented with weakness also reported numbness/tingling to top of right foot and right lower leg also pain to thoracic area radiating to left breast and left hand.Impression: patient presented with an acute exacerbation of back pain with complaints of subjective weakness and pain in bilateral upper extremities and bandlike pain along the t10 dermatome.She also compl ained of urinary incontinence and acute exacerbation of chronic back pain.The patient underwent x-rays of the lumbar spine.Impression: extensive thoracolumbar spinal fusion, without evidence of hardware malfunction.No evidence of acute osseous abnormality.Also the patient underwent x-rays of the thoracic spine.Impression: extensive thoracolumbar spinal fusion, without evidence of hardware malfunction.No evidence of acute osseous abnormality.The patient also underwent mri of the thoracic spine.Impression: posterior fusion of t3 to t10.Widely patent thecal sac with no evidence for cord compression.Limited evaluation of the neural foramina due to susceptibility artifact from pedicle screws, but no obvious neural foramina narrowing is appreciated.Hardware appears grossly intact.The patient also underwent mri of the lumbar spine.Impression: status post posterior spinal fusion of t12-l4 with normal appearance of the fusion hardware.Widely patent spinal canal and thecal sac.Limited evaluation of the neural foramina due to susceptibility artifact from adjacent pedicle screws, but no obvious neural foraminal narrowing.The patient underwent ct scan of the thorac ic spine due to backpain and urinary incontinence.Impression: status post posterior spinal fusion of the thoracic spine from t2 to t10.The hardware is intact and in good alignment with no evidence for hardware loosening.The patency of the neural foramen and spinal canal cannot be adequately assessed on this examination due to extensive metallic streak artifact.Mild edema in the subcutaneous fat posterior to the fusion hardware.The patient underwent ct scan of the lumbar spine due to back pain and urinary incontinence.Impression: status post posterior fusion of t12-l4 with normal appearance of the spinal hardware.Limited evaluation of the thecal sac and neural foramina due to streak artifact from the adjacent hardware.Small areas of cortical erosion involving the medial left iliac bone.Small amount of subcutaneous edema in the midline posterior of the hardware.On (b)(6) 2010 the patient presented with impaired strength/activity tolerance.The patient presented with severe back pain.On (b)(6) 2010 the patient reportedly underwent lumbar spine ct.Impression: no acute osseous injury.Status post posterior spinal f ixation of the thoracolumbar spine without evidence of hardware complication.The patient also underwent ct scan of the cervical spine.Impression: no acute osseous injury to the cervical spine.Moderate degenerative disk disease at c5-6.Multi level degenerative facet and uncovertebral hypertrophic arthropathy.Severe degenerative changes at the atlantoaxial joint.The patient underwent ct scan of the thoracic spine.Impression: 1.No acute osseous injury.2.Thoracolumbar posterior spinal fusion partially visualized without evidence of hardware complication.3.Stable grade 1 anterolisthesis of t2 on t3.Unchanged mild compression deformity of the superior vertebral end plate of t3, stable in comparison with the mri of (b)(6) 2010.4.Unchanged incomplete posterior fusion of bilateral posterior masses from t3 to t9 and complete osseous posteriorfusion from t10 to t12.On (b)(6) 2010 the patient reportedly underwent blood work which was normal.On (b)(6) 2010 the patient reportedly underwent a mri of the cervical spine and chest x-rays.On (b)(6) 2010 the patient presented with acute onset vertigo and sub acute worsening of her gait instability.Impression: imbalance.The patient underwent ct scan of the head due to new onset difficulty ambulating.Impression: 1.Essentially unremarkable non contrast ct exam of the head without and acute intracranial hemorrhage.2.Near complete opacification of the left maxillary sinus.The patient underwent x-rays of the chest.Impression: 1.Well expanded lungs.There are no focal consolidations, pleural effusions or pneumothorax.2.The cardiomediastinal silhouette is within normal limits.3.The hilar regions and trachea are within normal limits.4.Multilevel spinal fusion from the upper thoracic spine down to the lumbar spine and terminating outside the field-of-view.5.No acute cardiopulmonary disease.The patient underwent mri of the brain due to vertigo and cerebellar symptoms.Impression: mri of the brain within normal limits.There is no evidence of an acute infarct, extra cerebral collection, or mass.The ventricular size appears normal.Evidence of dense opacification of the left maxillary antrum with mucosal thickening is noted, suggesting chronic left maxillary sinusitis.Mild changes of right ethmoid sinusitis are noted as well.There is no evidence of an acute infarct on diffusion study.The patient underwent mri of the cervical spine for the evaluation of spinal cord impingement.Impression: 1.Multilevel spondylosis.The most abnormal intervertebral disk space is the c5-6 intervertebral disk space where there is evidence of degeneration and desiccation of the intervertebral disk space with a focal disk osteophyte complex mildly sloping to the right effacing the thecal sac and mildly flattening the right hemi-cord.2.The c6-7 intervertebral disk space demonstrates a small disk osteophyte complex mildly effacing the thecal sac anteriorly.3.The c4-5 intervertebral disk space demonstrates a small disk osteophyte complex mildly effacing the anterior aspect of the thecal sac.There is evidence of a 1.5 cm thyroid nodule involving the left lobe.Further evaluation with ultrasound is recommended.4.The patient is status post thoracic surgery with multiple pedicle screws in place.Also the patient underwent mri of the thoracic spine.Impression: 1.Stable grade i anterolisthesis of t2 on t3 with stable focal kyphosis at t2-3.2.Mild angulation of the cord at t2-3.3.No definite signal abnormality within the cord is noted at this level.4.Status post extensive fusion with stable fusion hardware.5.The overall character of the study is limited by the extensive fair magnetic artifact from the rods and pedicle screws.The patient underwent mri of the lumbar spine.Impression: status post spinal fusion from t12 to l4 with normal appearance of the fusion hardware and spinal canal.The spinal thecal sac appears normal.Extensive pedicle placement is noted.There is no evidence of a paraspinal mass.No significant interval change is identified.On (b)(6) 2010 the patient complained of dizziness and difficulty walking.The patient underwent mri of the brain, which demonstrated some maxillary sinus thickening.The patient underwent mri of thoracic spine, which demonstrated a stable listhesis with mild angulation of the cord at t2-3.No signal abnormality within the thoracic cord.Limited by metal artifact.The patient underwent mri of the cervical spine, which demonstrated multilevel degenerative changes.At c5-6 evidence for disc osteophyte, mild sloping effacing the thecal sac, mild right hemicord flattening.There were other multilevel disc osteophyte complexes.Also mentions thyroid nodule.On (b)(6) 2010 the patient presented for a follow up and reported lightheadedness that has been ongoing x 1 week and also she reported uncontrolled back pain.On (b)(6) 2010 the patient presented for psychiatric consultation due to depression and danger to self.Diagnosis: major depression, recurrent without psychotic features.The patient had poor posture and was unable to use an assistive device.On (b)(6) 2010 the patient presented for failed outpatient pain management.She suffered difficulty with mobility and reported uncon trolled back pain.On (b)(6) 2010 the patient presented for evaluation of neck, shoulder, and back pain.The patient complained of numbess in hands and urinary incontinence postlumbar spine surgery.Assessment: bilateral trochanteric bursitis, bilateral piriformis pain, cervical spondylosis with radiculopathy, postsurgical back pain, sacroiliac joint dysfunction.The patient also underwent psychiatric evaluation.On (b)(6) 2010 the patient complained of trapezius cramping and atrophy.She stated that her right wrist goes limp and she has pain in her arms and hands.The patient has more weakness in theright than the left but more numbness in the left.She complained of patchy numbness in the forearms at the ulna bilaterally.She also has weakness in the right leg.The patient underwent electromyography study.Impression: there is no evidence of radiculopathy or brachial plexopathy affecting the left upper limb.On (b)(6) 2010 the patient presented with pre-operative diagnosis of cervical radiculopathy.The patient underwent c7/t1 interlaminar cervical epidural steroid injection and cervical epidurography.No patient complications were reported.On (b)(6) 2010, in a telephone encounter, the patient reported muscle spasm on her back which is causing pain in her right arm.Possibility of surgery was discussed with patient.Impression: flat back deformity, retained thoracic instrumentation, thoracic spine pain, neck pain and radiating arm pain, degenerative disk disease of the cervical spine and moderate stenosis at c4-5.On (b)(6) 2010 the patient presented for a follow up for thoracic pain and cervical pain.She also complained of muscle spasm parascapular bilateral.On (b)(6) 2010 the patient presented with pre-operative diagnosis of thoracic radiculopathy.The patient underwent t1-2 inter laminar thoracic epidural steroid injection and thoracic epidurography.No patient complications were reported.On (b)(6) 2010 the patient presented with pre-operative diagnosis of thoracic spondylosis without myelopathy.The patient underwent the following procedures: 1.Injection, anesthetic agent and/or steriod, facet nerve, thoracic ievel: right t2, right t3, right t4, left t2, left t3 and left t4 2.Fluoroscopy for needle guidance.No patient complications were reported.On (b)(6) 2011 the patient presented for neurologic follow-up examination.Diagnostic impression: 1.Histories of complex kyphoscoliosis status post multiple surgeries with recent multilevel fusion and internal fixation.2.There is diminished bulk of the right trapezius, probable old spinal accessory neuropathy.3.Chronic pain with myofascial pain, unclear etiology.4.Secondary depression.On (b)(6) 2011 the patient underwent x-rays of chest single frontal view, which demonstrated no acute cardiopulmonary findings.On (b)(6) 2011 the patient underwent abdominal ultrasound due to chest pain, which demonstrated 1.Gall bladder findings compatible with acute cholecystitis including gallstones with a 2cm stone impacted in the gallbladder neck, pronounced wall thickening and tenderness to probe pressure.2.Dilated common bile duct without detectable obstructing stone.On (b)(6) 2011 the patient underwent venous duplex bilateral lower extremity imaging, which demonstrated negative for deep venous t hrombosis within the bilateral lower extremities on (b)(6) 2011 the patient underwent x-rays of abdomen, which demonstrated 1.Upright chest negative for free air, small pleural ef fusions evident.No pneumonic infiltrate or mass congestion.2.Re-demonstration of extensive posterior pedicle screw and vertical rod placement for scoliosis stabilization.3.No dilated air filled large or small bowel loops present to suggest obstruction.4.Moderate amount retained fecal material.The patient underwent x-rays of abdomen 1 view, which demonstrated 1.No dilated air filled large or small bowel loops present to confirm obstruction.2.Moderate amount of retained fecal material may reflect constipation although this does not appear pronounced within the rectosigmoid.3.Re-demonstration of extensive prior spinal surgical pedicle screw fixation for scoliosis, inferior vena cava filter placement, interbody fusion across the l3-4, l4-5, l5-s1levels.On (b)(6) 2011 the patient underwent x-rays of abdomen which demonstrated decreased retained stool in the right colon, now in the l eft colon.No evidence of small bowel obstruction.Increased gaseous distention of the rectum.Stable postoperative findings.On (b)(6) 2011 the patientpresented with complaints of vomiting and was diagnosed with nonspecific abdominal pain, dehydration and possible constipation.The patient x-rays of abdomen due to abdominal pain, which demonstrated 1.Mild constipation with no bowel obstruction, no pneumoperitoneum.2.New 1.8cm patchy opacity at the left upper lung which was not seen on the prior study from 3 months earlier.This might represent developing atelectasis but small pneumonia cannot be excluded.Tumor was unlikely.On (b)(6) 2011 the patient presented for neurologic follow-up examination, diagnostic impression: 1.Chronic pain syndrome status post multiple spinal fusion procedures.2.Residual mid to upper thoracic radiculopathy with chronic trunk pain.3.Shoulder girdle weakness of unclear etiology with possible bilateral dorsal scapular neuropathy per emg.4.Probable adjustment disorder related to medical condition.On (b)(6) 2011 the patient presented with neck pain and bilateral shoulder blade pain and underwent a comprehensive medical evaluation.Her upper extremities have pain especially with walking or eating.The pain begins as a muscle spasm and then becomes electrical in nature followed by weakness.Her pain improved with lying down and rest.Assessment: recurrent urinary tract infection, urinary incontinence, urges, history of vitamin d deficiency, preoperative cardiovascular evaluation.On (b)(6) 2011 the patient presented with neck burn.The patient had significant bilateral scalene pain with nerve pain radiating down her arms and numbness in hands when doing certain activities with her hands.On (b)(6) 2011 the patient presented for a follow up for bilateral periscapular pain.She also has significant difficulty with stabbing spasms between the shoulder blades with ambulation or elevation of her shoulder.On (b)(6) 2011 the patient underwent electromyography study which was mildly abnormal.On (b)(6) 2012 the patient presented with interscapular and cervical pain.She also reported that she has fluid in her upper trapezius area and when her shoulder is elevated she has pain and swelling.On (b)(6) 2012, it was reported that an emg described myopathy in the proximal muscles and suggested fascioscapulohumeral muscular dystrophy.Diagnoses: 1.Bilateral cs and/or c6 radiculopathy 2.Bilateral upper trunk plexopathy.On (b)(6) 2012 the patient presented with severe shoulder girdle and arm dysfunction for primary care follow-up.The patient has severe anxiety and panic issues regarding her current health which is exacerbating her pain on (b)(6) 2012 the patient presented with shoulder and scapular pain.The patient underwent a mri of the-bilateral brachial plexus which demonstrated postoperative changes at c7-t2.There was mild postoperative edema involving the soft tissues.There was no evidence of fluid collection.There was a mild atrophy of the deltoid, trapezius, supraspinatus muscles right greater than left.Given the lack of muscular edema, the atrophy most likely reflected dis-use atrophy.Also noted was a left thyroid nodule, measures 1.5 cm.The patient had escherichia coli uti that was treated with nitrofurantoin.On (b)(6) 2012 the patient underwent an analysis to detect the fshd deletion mutation.This analysis did not detect the deletion on c hromosome 4q35 that is associated with fshd.On (b)(6) 2012 the patient presented with intermittent pain and numbness in her upper limbs.This appears to be highly postural and most likely is a case of thoracic outlet syndrome.On (b)(6) 2012 the patientstated that she is feeling more spasm and pain in her neck and shoulders; more weakness in my forearms and ankles and cramping in the front of both lower legs.In addition, she has more and stronger electric like shock-like, shooting, burning and stabbing sensations.On (b)(6) 2012 the patient complained of left neck, left shoulder and upper back pain.On (b)(6) 2012 the patient underwent x-rays of the chest.Impression: 1.Large amount of stool throughout the colon.No evidence of obstruction or pneumoperitoneum.2.Ivc filters.3.The cardiomediastinal silhouette is unremarkable and the lungs are without evidence of consolidation, pleural effusionsor pneumothorax.4.Scoliosis hardware.On (b)(6) 2012 the patient presented with abdominal symptoms including nausea, bloating and epigastric discomfort with eating, symptoms began after patient received mild sedation 2 weeks ago.Upper extremity dysfunction, followed by neurology.The patient underwent plain film x-ray to evaluate for dilated loops of bowel.On (b)(6) 2012 the doctor discussed the x-rays results with patient that she underwent on her previous encounter.Findings: 1.Copious stool throughout colon.No large or small bowel distension.2.Fluid filled duodenum, indeterminate clinical significance.3.Ivc filter at level l# 4.Spinal stabilization hardware.On (b)(6) 2012 the patient presented with shoulder/upper back pain.The pain gets increased while using/raising arms.Also the patient reported that over a year ago she had her gallbladder removed and she might have a stone that rolled into her common deduct.The patient reported that she is having bloating, discomfort on right rib cage, nausea, and bowel problems.The patient called in and stated that she noticed blood on shower floor while taking a shower.The patient stated she was not sure where the blood is coming from.The patient did not want to continue evaluation and refused physical therapy.On (b)(6) 2012 the patient called in and stated that she has a history of uti and severe constipation.Also the patient stated that she is vomiting and also having gall bladder attacks/abdominal pain even though she is s/p cholecystectomy.On (b)(6) 012 the patient underwent ct scan of the abdomen/pelvis.Impression: 1.No acute intra-abdominal findings.2.The gallbladder is not visualized likely surgically absent.3.Large amount of stool throughout the colon.4.Scoliosis hardware.5.Small hiatal hernia.The patient also underwent ultrasound study of the abdomen.Impression: no significant abnormalities noted.Status post cholecystectomy.On (b)(6) 2012 the patient called in and reported abdominal pain.She cannot eat or drink without vomiting.On (b)(6) 2012 the patient presented with uti.Diagnoses: 1.Acute urinary tract infection, requiring intravenous antibiotic.2.Nausea and vomiting.On (b)(6) 2012 the patient for a f/u on a uti on (b)(6) 2012 the patient presented with a chronic regional pain syndrome of her shoulder girdle.There is a shoulder girdle myopathy, almost certainly not dystrophic, but associated with hypermobility of her scapulae, which is limiting her range of movement and inducing pain, mainly when there is separation of her scapulae.She also has bilateral arm symptoms that appear to be related to thoracic outlet syndrome brought on by collapse of the shoulder girdle related to weakness on (b)(6) 2012 the patient underwent neurofibromatosis type 1 evaluation.The results were negative and this panel of tests did not identify mutations associated with neurofibromatosis type 1.On (b)(6) 2012 the patient underwent electromyography.The study was normal and there was no convincing evidence of neurogenic right thoracic outlet syndrome.On (b)(6) 2012 the patient presented for a follow up visit post-shoulder girdle surgery.The patient has difficulty with protraction of shoulders, difficult, fatigue, then pain in inter scapular region, followed by same visceral reactions as before on (b)(6) 2012 the patient presented with no improvement in strength despite 12 weeks physical therapy, including active release and complained of pain in medial fore arm, fingers with certain movements.Also she reported numbness and tingling in medial 2 digits, hand, and medial left forearm near elbow.The upper left arm is getting worse and there is pain in left upper shoulder (mantle), feels tight (only when upright).Also there were tos symptoms on right, but less compared to the left.On (b)(6) 2014 the patient reported that thoracic/cervical and periscapular myofascial pain has been much better since having botox i njections.On (b)(6) 2014 the patient presented with shoulder and upper back pain.Also she complained of pain and weakness in her midline thoracic region.On (b)(6) 2014 the patient underwent ct neck with contrast and ct chest with contrast, which demonstrated 1.No acute cardiopulmonary process.No acute disease demonstrated in the neck.No evidence of airway compromise.No abscess.2.Chronic appearing right paranasal sinusitis.3.Stable several small subcentimeter thyroid nodulesand stable tiny pulmonary nodules as compared to the previous ct study.On (b)(6) 2014 the patient underwent mri of lumbar spine without contrast, which demonstrated extensive posterior fusion, significant metallic artifact.No evidence of marrow edema.No paravertebral soft tissue abnormality.No central canal stenosis or significant neural foraminal stenosis.The visualized spinal cord, conus and phylum were without significant abnormality.Unremarkable alignment.The patient underwent mri of thoracic spine without contrast, which demonstrated postoperative fluid in the right posterior subcutaneous upper sacral region measuring 6.5x3.5cm.On (b)(6) 2014 the patient stated that she has been having episodes of shortness of breath and coughing since last week in a telephone encounter.Also she reported ankle pain, which is associated with her arthritis condition.On (b)(6) 2014 the patient presented with increased shortness of breath and has noticed increase in arthralgias specifically in right ankle/wrist.
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Event Description
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On (b)(6) 2009: the patient underwent two views of thoracic spine due to thoracic pain.Conclusion: mild degenerative changes in the mild to lower thoracic spine with a mild kyphosis; bony fusion from the lower thoracic spine into the lumbar spine.The patient also underwent minimum four views of cervical spine due to neck pain.Conclusion: moderate degenerative disc disease at c5-6.The patient also had four views of complete lumbosacral spine due to lower back pain.Conclusion: rotary scoliosis with bony fusion from the lower thoracic spine to the sacrum; degenerative changes at multiple levels in the lumbar spine; there is no abnormal motion.On (b)(6) 2009, reportedly, the patient underwent mri of cervical spine, without contrast, due to pain.Impression: small disc-osteophyte complexes at c3-4, c4-5, c5-6 and c6-7 levels without significant central canal stenosis; neural foraminal narrowing is moderate at c4-5 and c5-6 bilaterally; no herniating disc fragments are seen.The patient also underwent mri of thoracic spine, without contrast, due to pain.Impression: 1.Focal left paracentral disc protrusion and left ligamentum flavum thickening at t8-9 indenta the left ventral aspect of the spinal cord.2.Disc bulge at t9-10 effaces the ventral csf column, mildly narrows the right foramen, and moderately narrow the left neural foramen.3.Tiny cavity versus focal enlargement of the ependymal canal at t8-9 to t9-10, for which follow-up is advised.4.T8-9 endplate signal changes most likely represent fibrovascular tissue secondary to degenerative chages, but follow-up is recommended.5.Small left paracentral disc protrusion at t2-3 without central canal or neural foraminal compromise.On (b)(6) 2009: the patient underwent mri of lumbar spine, without contrast, due to history of lower back pain.Impression: 1.Status post l4-5 and l5-s1 fusion as well as posterior spinous process fusions.2.Mild central canal stenosis at l4-5.3.Moderate foraminal narrowing on the right at l4-5 and on the left at l5-s1.On (b)(6) 2009, the patient underwent xr spine scoliosis standing.Impression: mild s-shaped scoliosis noted; previous multi-level lumbar fusion with solid-appearing right-sided graft; moderate thoracic kyphosis.(b)(6) 2009, per billing records, the patient presented in er and underwent various labs including but not limited to a cbc, urinalysis, and prothrombin.The patient underwent a ct of the lumbar and thoracic spine and a mri of the thoracic spine.The patient presented with complaining of right lower extremity numbness and difficulty ambulating.Assessment: right lower extremity hypoesthesia and persistent and stable bowel and bladder incontinence; hypertension, continue lopressor; fluid electrolyte nutrition; history of thoracic myelopathy, status post sacral thoracic fusion; deep venous thrombosis and gastrointestinal prophylaxis with lovenox and protonix; positive urinalysis.The patient underwent ct of spine thoracic w/o contrast for injury spnal cord site.Impression: no evidence of fracture or malalignment on the lateral view.Spinal canal dimensions are capacious; significant mid thoracic degenerative change, particularly t7 through t10; fusion through the lumbar spine up to t10, which appears solid; question changes of transition syndrome with slightly widened facet joints at the t9-10 level with no evidence of gross malalignment.The patient underwent ct lumbar spine without contrast.Impression: solid bony fusion from the sacrum to t10; capacious spinal canal without evidence of significant canal or neural foraminal narrowing; access for a myelogram might be accomplished at the l4 level.The patient underwent mri of thoracic spine due to injury spinal cord site.Impression: small lower thoracic syrinx of uncertain clinical significance.On (b)(6) 2010: the patient underwent radiology exam of entire spine due to scoliosis.Impression: bone demineralization; scoliosis; degenerative disc disease.On (b)(6) 2010, reportedly, the patient presented with the preoperative diagnosis of thoracic disk herniation, thoracic kyphosis and thoracic myelopathy.The patient underwent surgery which consisted of: posterior spinal fusion from t3-l4 with t8-t9 and t9-ti0 laminectomies and smith-peterson osteotomy t8-t9, t9-t10.Reportedly there were problems on the patient awaking in the recovery area.They had upper extremity weakness with lower extremities intact and radiating right arm pain.The patient underwent intra-op radiology exam of thoracolumbar spine fusion, l4-post fusion.Findings: multiple spot fluoroscopic images were obtained which demonstrated localization and subsequent placement of multiple pedicle screws and posterior rods.The patient also underwent film cxr.Impression: the distal tip of the right sided central venous catheter is projected over the central superior vena cava.Posterior thoracic spine fusion rods and transpedicular screws.Skin staples.The patient also underwent an mri for neck pain, numbness and grip loss on both upper extremities.The patient was examined for status post extensive back surgery for scoliosis.Final impression: the patient appeared stable postoperatively except for hypertension.On (b)(6) 2010: the patient underwent radiology exam of entire spine due to scoliosis.Findings: postsurgical changes are redemonstrated with spinal rods in place from approx.T3-l4; pedicle screws are in place at each level except for t11; the bones are osteopenic; scattered degenerative changes are seen; surgical clips overlie the lumbosacral junction; surgical drain and posterior skin staples have been removed; thoracolumbar levoscoliosis measures approx.33 degrees by the method of cobb.On (b)(6) 2011: the patient presented with following pre-operative diagnoses: 1.Failure of previous lumbar fusion, t3-l4 with subsequent l4 vertebral body and pedicle fracture.2.Post fracture kyphosis and loss of sagittal balance and progressive post fracture scoliosis l3-4 status post deformity and postsurgically related fracture l4.3.Postsurgical kyphosis and degenerative disk disease with associated possible intermittent spinal cord compression due to mobile kyphosis t2-t3.4.Patient being status post revision instrumentation with removal of previously placed hardware t3-l4 with re-instrumentation c7 to the pelvis performed on (b)(6) 2011.The patient underwent the following procedures: 1.Completion of pedicle subtraction osteotomy l4.2.Transverse lumbar interbody fusion for stabilization of progressive generative disk disease, l3-4.3.Completion of instrumentation and fusion c7 to the pelvis with local bone grafting.Per op notes, bone grafting was performed after decortication of the cervical and thoracic spine from c7 down to approximately t6, posterior allografting was then performed using a combination of local bone, beta tricalcium phosphate and bone morphogenic protein placed directly over the exposed decorticated surfaces bridging the area.Similar grafting procedure was then done of the lumbar spine from approximately from the fusion mass of the lumbosacral junction up into the upper lumbar spine at approximately t12-l1.With posterior grafting completed bilaterally at each junctional segment, the surgical wound was then irrigated and then closed.There were no known patient complications.(b)(6) 2011: physical examination revealed tenderness to palpation of the scalene muscles with pain posteriorly in the region of the rhomboids.On (b)(6) 2011: on examination, the patient had tight lateral scalene muscles with compression at the base of the scalenes aggravating pain into the midscapular area.The patient also had difficulty abducting the shoulder on either side.There was moderate tenderness over the rhomboid areas.On (b)(6) 2012: the patient also underwent electromyography study, the result of which was abnormal.On (b)(6) 2012: the patient presented with the following diagnoses: 1.Type 2 fiber atrophy, slight.2.Minor nonspecific myopathic abnormalities.On (b)(6) 2012: the patient presented with severe pain in upper limbs, shoulders and upper back that are highly positional.The pain was aggravated by physical activity and produced a sensation of intense muscle spasm in shoulder girdle that appeared to distort the position of her scapulae.The patient also complained of weakness in lower limbs.On (b)(6) 2012: the patient presented for orthopedic consultation.Assessment: there was evidence of significant atrophy of the shoulder girdle musculature, but the cause was unclear.On (b)(6) 2012: the patient presented for neurological consultation, with posterior and anterior neck pain, shoulders and upper extremities pain.The patient also complained of weakness of the shoulder musculature, low back pain, leg pain, difficulty with ambulation, headaches, numbness, muscle cramps, severe muscle twitching in left leg and reported that her arms were flaccid.The patient also had the following symptoms: scapula does not feel stabilized against the chest wall; moving arms across the body causing intense pain; arm movement causing pain in cervical thoracic area causing sweating, nausea, fatigue in shoulders, inability to remain standing or continue walking.Musculoskeletal examination revealed that the cervical spine motions were limited by tightness; there was tenderness and discomfort with gentle pressure of the cervical paraspinal and superior trapezius muscles, left more than right; active lumbosacral spine motions were absent, compatible with her fusion surgeries.Clinical impression: 1.Scoliosis surgeries complicated by myelopathies followed by subsequent spinal surgeries with relief of myelopathic symptomology since (b)(6) through her 50s: a.(b)(6) 2010 lower cervical/upper thoracic spine surgery followed by complication of weakness and numbness of the upper extremities.B.Gradual improvement in strength in the forearm and upper arm muscles with residual weakness and atrophy of the shoulder girdle m uscles.C.Minimal symptomology suggesting some residual myelopathy with occasional urinary incontinence, with clinical examination with regard to myelopathy remarkable for mild impairment of the amr of the lower extremity.On (b)(6) 2012: the patient presented for neurological consultation, with problems of neck, shoulders and upper extremities.Initial evaluation revealed thinning of the musculature in the neck and posterior shoulder area with the ability to activate the muscle groups in the shoulder and upper extremity but not produce full functional movement of upper extremities at the shoulder joints.The biopsy of the left trapezius and serratus anterior muscle showed only disuse atrophy.Clinical impression: 1.Scoliosis surgeries complicated by myelopathies followed by subsequent spinal surgeries with relief of myelopathic symptomology since (b)(6) through her 50s: a.(b)(6) 2010 lower cervical/upper thoracic spine surgery followed by complication of weakness and numbness of the upper extremities.B.Gradual improvement in strength in the forearm and upper arm muscles with residual weakness and atrophy of the shoulder girdle muscles.C.Minimal symptomology suggesting some residual myelopathy with occasional urinary incontinence, with clinical examination with regard to myelopathy remarkable for mild impairment of the amr of the lower extremity.D.Muscle biopsy, left trapezius and left serratus anterior without specific diagnosis ((b)(6) 2012).E.Possible combination of positional paralysis of the shoulder girdle muscles followed by an episode of neuralgic amytrophy following (b)(6) 2010 lower cervical/upper thoracic spine surgery.F.Treatment options include botulinum toxin injections followed by renewed physical therapy.On (b)(6) 2012: the patient also complained of numbness of the thoracic paraspinal skin, muscle pain and tenderness of the upper trapezius muscles.On (b)(6) 2012 : the patient presented with neck pain and shoulder pain.
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Manufacturer Narrative
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(image review): (b)(6) 2011 cxr no comment (b)(6) 1011 cardiac echo no comment (b)(6) 2011 doppler ultrasound no comment (b)(6) 2011 cxr no comment (b)(6) 2011 x rays spinal hardware unchanged.On (b)(6) 2011 chest x ray spinal hardware is present from scoliotic deformity correction.Levels extend beyond window, but does extend to ilium.Lower and upper segments connected with domino transition (b)(6) 2014 ct contrast pe protocol no comment (b)(6) 2014 ct t spine extensive beam hardening artifact, cervico thoracic hardware is present and appears intact.Unable to count top level impression: unclear from narrative and patient imaging what the generated complaint is.Extensive scoliotic deformity hardware is present and appears intact.Imaging modalities provided do not allow for adequate examination of the lower lumbar levels where the interbody devices are placed or for the degree of fusion throughout the length of the construct.Root cause indeterminate.
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Manufacturer Narrative
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Additional information: pt identifier, age/date of birth, model/lot #, device manufacture date.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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