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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 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Fatigue (1849); Fever (1858); Headache (1880); Muscle Spasm(s) (1966); Muscle Weakness (1967); Muscular Rigidity (1968); Nausea (1970); Pain (1994); Rash (2033); Swelling (2091); Tingling (2171); Dizziness (2194); Stenosis (2263); Sore Throat (2396); Numbness (2415); Sleep Dysfunction (2517); No Code Available (3191)
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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 transforaminal lumbar interbody fusion and a posterolateral fusion at l5-s1 using rhbmp-2/acs.On (b)(6) 2008, patient was diagnosed with heterotopic bone growth, secondary to rhbmp-2 at the right neuroforamen of the s1 nerve root.As a result, patient has required extensive medical treatment, including having to undergo an additional surgery involving a microdissection with decompression of the l5-s1 disc space and of the foramen at the right s1 nerve root.
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Manufacturer Narrative
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(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.
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Manufacturer Narrative
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Event Description
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It was reported that on (b)(6) 2008 the patient presented low back pain with bilateral sciatic pain and the preoperative diagnosis of right paramedian herniated disk with chronic bilateral s1 radiculopathy.The patient underwent surgery which consisted of a right transfacet nerve root decompression; discectomy; preparation of endplates for interbody fusion with rhbmp-2, hydroxyapatite bone matrix, and cage prosthesis, micro-dissection; and internal fixation and lateral fusion.Per the operative report ¿¿ a ball dissector was used to palpate along the proximal course of the s1 and l5 nerve root on the right confirming adequate decompression.The dissector was also passed medially, ruling out any residual disk fragments.Next, a piece of reconstituted rhbmp-2 sponge, approximately 0.7 ml, was placed into the disk space and pushed anteriorly.This was followed by 3.5 ml of formagraft.The formgraft was then compressed with impactors.Formagraft 1.5ml was placed into the cage, along with 0.7 ml rhbmp.2 sponge.The lordotic cage was 9 x10x 23 mm in dimension and was placed into the disk space and counter-sunk approximately 3 mm¿¿ then attention was turned to the internal fixation ¿¿the metallic rod was then attached.Decortication done along the lateral gutter of l5 and s1 and 2.1 mg small bmp was mixed with formagraft, 5 ml for the lateral fusion¿.¿ no patient complications were noted.X-rays were taken which showed good alignment.On (b)(6) 2009 the patient was discharged from hospital.On (b)(6) 2008 the patient presented with increasing low back pain but resolved sciatica pain.On (b)(6) 2008 the patient presented with constant mid and low back pain aggravated by sitting or standing.There was some bilateral paraspinal tenderness and mild bilateral s1 joint tenderness.Ap and lateral x-rays showed evidence of early though incomplete fusion at l5-s1 with good position of the interbody cage.On (b)(6) 2008 the patient presented with pain and underwent a lumbar spine mri which demonstrated postoperative changes consistent with the history of l5-s1 right sided discectomy fusion procedure with no evidence of recurrent disc herniation or neural impairment.On (b)(6) 2008 the patient presented with low back pain and occasional muscle spasms.Per the doctors notes a recent mri showed some mild epidural scarring on the right l5-s1 with no significant nerve root compression.There appeared to be bone density which extended outside of the disk space into the epidural region, however this was not well visualized.The doctor wanted to rule out ectopic ossification in the epidural space.On (b)(6) 2008 the patient presented for an evaluation of the l5-s1 fusion and underwent a lumbar spine ct which demonstrated hardware was in place; a heterotopic bone formation posteriorly at l5-s1 disc space causing narrowing of the central canal in that location; bone fragment or spur at the right superior articulating facet causing narrowing of the right l5/s1 neural foramen; and the appearance of incomplete fusion.On (b)(6) 2009 the patient complained of constant low back pain which radiated into the right leg to the toes and also the front groin and anterior thigh.There was mild paravertebral tenderness on the right side and some mild sciatic notch tenderness.The patient presented with a slow deliberate gait.Per the doctors notes imaging studies had shown ectopic formation of bone fusion in the neural foramina at l5-s1 on the right.On (b)(6) 2009 the patient complained of constant low back pain which radiated into the right leg to the toes and also the front groin and anterior thigh.Diagnostic imaging (ct and mri) from (b)(6) 2008 were reviewed.This imaging showed an extension of the fusion mass outside of the disk space along the tract of the cage into the epidural space on the right side with encroachment of the l5-s1 neural foramen.On (b)(6) 2009 the patient presented with low back pain and right l5 radiculopathy secondary to heterotopic bone formation and foraminal stenosis at l5-s1.On (b)(6) 2009, 1 year post l5-s1 tlif, the patient presented with progressively worse radicular pain on the right side with the pre operative diagnosis of right l5-s1 foraminal stenosis due to heterotopic bone formation, status post l5-s1 tlif with rhbmp-2.The patient underwent surgery which consisted of a right l5-s1 re-exploration, micro dissection, and nerve root decompression.Per the operative report dissection was carried out; calcified tissue was removed from within muscle; hyperesthetic bone material was removed; the l5 nerve root was identified as it existed above the disk space and was noted to be partially encased in bone ¿ the bone was removed; residual scar tissue was removed from the l5 nerve root; adequate compression was confirmed.No patient complications were reported.On (b)(6) 2009, 2 weeks post op, the patient presented with right sided leg paresthesias and low back pain.The patient continued to have burning dysesthesias in an l5 distribution in the right leg.Per the doctor's notes ¿patient remains about the same with radicular pain following decompression.This is most likely associated with residual nerve root edema.¿ on (b)(6) 2009, in a call to the doctor's office, the patient reported twisting back while sleeping and requested something to help with spasms.On (b)(6) 2009 the patient presented with improving back pain ¿ no leg pain or radicular symptoms reported.The residual nerve root edema had slowly resolved.On (b)(6) 2010 the patient presented with gradually increasing low back pain and constant sacral pain aggravated with activity.The patient also had some mild bilateral leg pain, right greater than left.There was mild paraspinal muscle tenderness inferiorly.On (b)(6) 2010 the patient presented with pain and underwent a lumbar spine mri which showed postoperative changes consistent with the history of l5-s1 right sided discectomy fusion procedure with recurrent disc herniation or neural foraminal narrowing; there was a lesion in the s1 segment which was compatible with a benign etiology such as hemangioma; bilateral ovarian cystic lesions; and a retroflexed uterus.On (b)(6) 2010 the patient presented with low back and sciatica.The doctor reviewed a recent taken pelvic/sacral mri which showed some scarring in the epidural space on the right compatible with the prevision decompression study and areas of hyperintensity within the sacrum, especially around s2 which mostly represented a hemangioma however other lesions needed to be ruled out.On (b)(6) 2010 the patient presented with low back and sciatica and underwent a nm bone and joint scan which showed minimal uptake in the right aspect of the l5-s1 interspace compatible with previous post-surgical changes; and no concerning foci of uptake identified in the pelvis of visualized lumbosacral spine.On (b)(6) 2010 the patient presented with low back, sciatica, and some mild tenderness of bilateral s1 join and bilateral paraspinal.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2008 the patient complained of low back pain and right leg pain.
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Event Description
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It was noted that on (b)(6) 2014 the patient presented for a follow up visit to review lab results.The patient complained of depression.Assessment: allergic rhinitis due to other allergen; panic disorder without agoraphobia.(b)(6) 2014 the patient presented with the complaint of lower back pain, muscle aches and joint pain.Assessment: lumbar disc degeneration.(b)(6) 2014 the patient presented with the complaint of pain to right foot.Assessment: foot pain; sleep disorder.(b)(6) 2014 the patient presented with allergy symptoms and complained of both upper lids swollen mostly in the morning, both eyes itchy and weepy x 1 month.Assessment: allergic conjunctivitis.(b)(6) 2014 the patient presented with transient right sided facial numbness and head ache.The patient has had several episodes where she has spasm to the right side of her muscle distribution of the facial nerve numbness and a slight headache.Diagnosis: facial nerve disorder.The patient underwent ct of the brain due to facial tingling.Impression: normal non contrast study.No acute intracranial bleed, mass effect or other acute intracranial process.(b)(6) 2014 the patient presented for a follow up post er visit.She had aching pain in head and complained of right sided facial numbness and depression.Assessment: trigeminal neuralgia; panic disorder without agoraphobia.(b)(6) 2014 the patient presented for a follow up with cold symptoms and complained of sore throat, non productive cough, nasal congestion, head ache, body aches, and slight intermittent nausea.Patient reports being very thirsty and swelling of face.The patient also had chronic, intermittent, aching, burning low back pain with radiation into legs occasionally.Assessment: acute nasopharyngitis.(b)(6) 2015 the patient presented with the chief complaint of allergic reaction.The patient noticed itchy rash to chin, left inner eye, numb and feels like a ball in the back of throat and occasional cough.(b)(6) 2015 the patient presented to the er with complaint of rash and itch to her skin, the left side of her nose, as well as feeling like there is a ball swelling in the back of her throat.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2008: the patient presented to physical therapy with lumbosacral pain.Palpation confirmed pain in posterior belt area and both sacroiliac joint lines.The patient also had feeling of heaviness in right thigh, anterior and posterior.Assessment: pain and muscle spasms in lumbosacral area; weakness and decreased balance in extremities.On (b)(6) 2008: the patient presented to physical therapy for her back pain, and also complained of occasional sciatic pain in her right leg.On (b)(6) 2009: the patient presented to start her pre-op work up for second surgery on lumbosacral spine.The patient also had some paresthesias and complained of mild memory problems.Musculoskeletal examination revealed muscle and joint pain and stiffness with radiating pain into right foot.Psychiatric examination revealed anxiety, irritability and depression.Assessment: spinal stenosis; stress reaction mixed disorder; recurrent major depressive mild; unspecified chronic sinusitis.On (b)(6) 2009: the patient presented for an office visit and complained of twisted back while lying down on floor.On (b)(6) 2010 the patient underwent limited bone scan of the pelvis and lower lumbosacral spine due to low back pain and s2 lesion seen on mri.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that (b)(6) 1998 the patient underwent ct of the abdomen/pelvis.Impression: normal ct of abdomen and pelvis.Special attention to the adrenal glands and adnexal structures revealed no masses or other abnormalities.(b)(6) 2000 the patient presented with low back pain with some radiation into the left buttock area due to a work related injury.The patient underwent x-rays of the lumbosacral spine.Impression: minimal degenerative end plate osteophytes.Otherwise unremarkable.(b)(6) 2000 the patient underwent ct of the lumbar spine.Impression: normal ct scan of the lumbar spine.(b)(6) 2000 the patient presented with pre-op diagnosis of lumbar disc derangement l5-s1 with left leg pain.The patient underwent the following procedure: epidurography, supervision and interpretation of the left l5 and s1 neuroforamen.(b)(6) 2001 the patient underwent mammogram screening.Impression: mild prominent fibroglandular parenchyma in the posterior upper aspect of both breasts.Given this symmetry this is probably benign.(b)(6) 2001 the patient underwent ugi exam for epigastric pain.Impression: intermittent gastroesophageal reflux seen during the study.Otherwise, normal exam.(b)(6) 2002 the patient presented with refractory gerd.She also reported nausea and intermittent coughing.Her main complaint was really the burning pain in the chest area, especially after meals which really sound iike gerd.(b)(6) 2002 the patient underwent upper endoscopy procedure.Impression: 1.Small hiatal hernia.2.Symptoms consistent with gastroesophageal reflux disease.(b)(6) 2002 the patient underwent nm gastric emptying study.Impression: normal gastric emptying study.(b)(6) 2002 the patient underwent mammogram, bilateral diagnostic.Impression: 8 x 6 mm asymmetric density in the upper aspect of the left breast only seen on the medioblique and mediolateral views.Also she underwent ultrasound study of the breast.Impression: no sonographic evidence of solid or cystic lesions.(b)(6) 2002 the patient presented with some subjective swelling in both of her hands.She also complained of being short of breath, having some pleuritic chest pain but not coughing, and having intermittent carpal pedal spasms in her fingers.The patient underwent x-rays of the chest.Impression: normal chest.(b)(6) 2002 the patient underwent ct of the head which demonstrated questionable tiny lacunar infarct in the left basal ganglia.Given this patient's age, this would be somewhat unusual.(b)(6) 2002 the patient underwent mri of the brain.Impression: normal mri of brain.No evidence of infarction or other significant abnormality to explain the recent ct finding.(b)(6) 2002 the patient underwent mammogram, left diagnostic.Impression: previously noted focal density in left upper breast tissue is less circumscribed on today's study.Current appearance is more consistent with a focal area of fibro glandular density.A mass is felt to be unlikely but continued follow up is suggested with next evaluation in six months at the time of the bilateral screening exam.(b)(6) 2002 the patient was admitted due to sudden onset of right lower quadrant pain during intercourse.She noted that the pain spread to the left thigh but was mostly concentrated on the right side.The patient was noted to have a 3 cm right ovarian cyst on cat scan.She complained of anorexia and she had three episodes of emesis.Assessment: possible ovarian cyst rupture with history of sudden onset of pain during intercourse.The patient underwent ct of the pelvis.Impression: 1.No evidence of appendicitis but the appendix is not visualized therefore further evaluation for appendicitis should be based on the clinical findings.2.3 cm right ovarian cyst.The patient also underwent x-rays of the chest.Impression: no evidence of acute cardiopulmonary disease.(b)(6) 2002 the patient was admitted with the history of right lower quadrant abdominal pain and tenderness.The patient was referred for surgical consultation for the possibility of appendicitis.A ct scan of the abdomen initially on presentation in the emergency room revealed that it was unable to visualize the appendix despite oral and rectal contrast, and therefore appendicitis cannot be ruled out.Diagnoses: 1.Severe right lower quadrant and low abdominal pain and tenderness.2.Ruptured ovarian cyst, right side, complex ovarian mass.The patient underwent ultrasound study.Impression: right ovarian 3 cm complex cyst and associated free fluid, which could be related to cyst rupture.The patient underwent ct of the pelvis.Impression:1.Normal ct of the appendix.No evidence of appendicitis.2.Persistent right adnexal cyst.(b)(6) 2003 the patient underwent ultrasound study.Impression: 1.Bilateral follicular cysts 2.Several sub endometrial cysts in the lower uterine segment.(b)(6) 2004 the patient underwent x-rays of the chest.Impression: no acute disease.The patient underwent x-rays of the paranasal sinuses.Impression: normal paranasal sinuses.(b)(6) 2005 the patient underwent ct of the lumbar spine.Impression: 1) small- right paracentral disc protrusion at l5-s1 - just abutting the ventral aspect of the right s1 nerve root.2) mild diffuse broad based disc bulge at l4-5.(b)(6) 2006 the patient underwent ultrasound study for pelvic pain.Impression: 1.Bilateral follicular ovarian cyst.2.Tiny amount of fluid within the pelvis, which is likely physiologic.(b)(6) 2007 the patient underwent x-rays of the chest.Impression: no acute cardiac or pulmonary disease.(b)(6) 2007 the patient presented with back pain radiating down both legs but especially on the right posterior thigh.Diagnosis: sciatica.(b)(6) 2007 the patient presented with upper back and neck spasm.The patient described pain to the left posterior thorax and the trapezius area and the right lateral neck.(b)(6) 2007 the patient underwent mri of the lumbar spine due to lumbar radiculopathy.Impression: 6 mm right paracentral posterior disc protrusion and disc extrusion at l5-s1.(b)(6) 2008 the patient presented with low back pain and bilateral leg pain.She also complained of muscle weakness, transient paralysis and paresthesias.Assessment: degenerative disc disease, lumbar spine; tobacco user; low back pain, chronic; herniated lumbar disc, l5-s1, right paramedian.(b)(6) 2008 the patient underwent x-rays of the chest.Impression: mild hyperinflation.No evidence of acute cardiopulmonary disease.(b)(6) 2008 the patient presented for a pre-op visit and complained of back pain.(b)(6) 2008 the patient underwent ct of the chest.Impression: small to moderate pleural effusions and scattered faint interstitial and air space opacities in the left lung.There is no ct evidence of pulmonary embolus.The patient underwent x-rays of the chest due to shortness of breath.Impression: development of mild chf changes including a small left pleural effusion.(b)(6) 2009 the patient underwent x-rays of the chest.Impression: probable chronic interstitial disease with reticular nodular densities.(b)(6) 2009 the patient underwent rest/stress echocardiogram.Conclusions: normal stress echocardiogram and normal ecg stress test wi th normal pulse response to exercise.(b)(6) 2009 the patient underwent x-rays of the chest.Impression: normal chest.(b)(6) 2009 the patient underwent ct of the sinus due to chronic sinusitis.Impression: 1.Normal appearance to the paranasal sinuses.2.Mild deviation of the nasal septum to the right.(b)(6) 2010 the patient presented with bilateral lower extremity edema.(b)(6) 2010 the patient presented with lower back pain.(b)(6) 2010 the patient presented with recurring back pain.(b)(6) 2010 the patient presented complaining of right ear ache and pain in right side of neck.(b)(6) 2010 the patient presented with dyspnea.The patient underwent x-rays of the chest for shortness of breath.Impression: normal study.The heart size is normal, with no enlargement of the hilar or mediastinal soft tissues.Ekg demonstrated no evidence of acute ischemia, infarction or predisposition toward tachy dysrhythmia.Also the lab results did not suggest deep venous thrombosis or pulmonary embolism.(b)(6) 2011 the patient presented with complaints of cough, headache, nasal discharge, and sore throat.She also reported shortness of breath.(b)(6) 2011 the patient presented with lower back pain.She also complained of anxiety attacks and shortness of breath.(b)(6) 2011 the patient noticed blood in the urine and came to the hospital for an evaluation.She also complained of back pain.(b)(6) 2011 the patient presented with sinus congestion & headaches and right ear congestion x 2 weeks.(b)(6) 2011 the patient presented with onset of cough and fever.The cough was worse at night.(b)(6) 2012 the patient presented with complaints of stomach pain, nausea and diarrhea x 4 days.The patient underwent acute abdominal series for abdominal and epigastric pain.Impression: no evidence of acute disease with post operative changes in the lower lumbar spine.(b)(6) 2012 the patient presented with complaints of chest pain and some light headedness.She also reported occasional nausea.(b)(6) 2012 thepatient underwent mammography screening.Impression: focal area of asymmetry in deep right upper outer breast.This patient will be contacted to return for additional views and possible ultrasound of this area.(b)(6) 2012 the patient underwent mammo dx uni rt for rt asymmetric density.Impression: stable mammographic findings.No significant interval change since earlier studies.(b)(6) 2012 the patient presented with pain in right elbow and underwent x-rays of the right elbow.Impression: normal right elbow.(b)(6) 2012 the patient presented with bilateral elbow pain which was worse on the right.There was intermittent sharp tenderness over the lateral epicondyle.(b)(6) 2012 the patient presented with bilateral elbow pain right greater than the left which is aggravated by the movement of hand and she also reported lower back pain.(b)(6) 2013 the patient underwent x-rays of the cervical spine.Impression: 1.Degenerative disk disease c5/c6.2.Mild reversal of l ordosis, nonspecific, possibly positional or from muscle spasm.(b)(6) 2013 the patient presented with nasal congestion and runny nose.(b)(6) 2013 the patient presented for a follow-up on cold.(b)(6) 2013 the patient complained of intermittent sudden bouts of getting butterflies in her stomach along with getting hot and sweaty, feeling flushed.(b)(6) 2013 the patient underwent x-rays of the chest.Impression: no acute pulmonary disease.No convincing evidence of active tuberculosis.The patient also complained of back pain and stiffness.Cervical spine x-ray from (b)(6) 2013 showed degenerative disc disease at c5-6 with moderate narrowing.(b)(6) 2014 the patient underwent mri of the cervical spine.Impression: degenerative disc disease at c5-6, with left uncovertebral joint hypertrophy and mild left-sided foraminal narrowing.(b)(6) 2014 the patient presented with right ear pain with decreased hearing x 1 month, occasional dizziness and itchiness x 1 month.The patient was also having right jaw pain from bottom of ear down jaw.(b)(6) 2014 the patient underwent ct of the head due to history of head ache.Impression: normal ct scans of the head without contrast.(b)(6) 2014 the patient presented feeling very fatigued and swollen especially in legs.
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Manufacturer Narrative
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Concomitant products: hydroxyapatite bone matrix, cage, formagraft, pedicle screws (implant (b)(6) 2008).(b)(6).(b)(4).
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Event Description
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It was reported that the patient presented with complaints of low back pain and bilateral leg pain, right greater than the left.The patient with pre-op diagnoses of right paramedian herniated disk with chronic bilateral s1 radiculopathy underwent right transfacet nerve root decompression, discectomy, preparation of endplates for interbody fusion at l5-s1 with rhbmp- 2, hydroxyapatite bone matrix, cage prosthesis, microdissection.Per op notes, a piece of reconstituted rhbmp-2 sponge, approximately 0.7 ml, was placed into the disk space and pushed anteriorly.This was followed by 3.5 ml of formagraft.The formagraft was then compressed with impactors.Formagraft 1.5 ml was placed into the cage, along with 0.7 ml rhbmp-2 sponge.The lordotic cage was 9 x 10 x 23 mm in dimension and was placed into the disk space and counter-sunk approximately 3 mm.No patient complications were noted.Also the patient underwent the remaining portion of the procedure which included internal fixation with pedicle screws and lateral fusion due to herniated lumbar disk, l5-s1, with chronic back pain.Per op notes, decortication was done along the lateral gutter of l5 and s1 and 2.1 mg used and small bmp was mixed with formagraft, 5 ml for the lateral fusion.No patient complications were noted.X-rays of the lumbar spine showed l5-s1 fusion is well aligned.Neurologic function was monitored during the surgery by means of somatosensory evoked potentials from upper and lower extremities, free running emg, and stimulus-triggered emg.Impression: 1.Stable somatosensory evoked potentials from the upper and lower extremities.2.Free-running emg, showing rare periods of nerve root irritation at the right l5 and s1 level.3.Stimulus triggered emg did not suggest an increased likelihood of continuity between neural structures and surgical hardware or breach of central canal.Post-operatively, the patient had severe back pain and right sided sciatica.Pain management was consulted and the patient was discharged home on (b)(6) 2008.(b)(6) 2008 the patient presented for physical therapy and currently limited in her mobility due to post-op pain.(b)(6) 2008 the patient was discharged with principal diagnoses of l5-s1 herniated disk with secondary bilateral s1 radiculopathy and secondary diagnoses of depression and prolonged tobacco use.(b)(6) 2008 the patient presented for office visit with complaint of shortness of breath, dizziness.Impression: l5-s1 herniated disk with secondary bilateral s1 radiculopathy; history of depression; recent history of tobacco use.The patient underwent intraoperative monitoring report.Impression: stable somatosensory evoked potentials from the upper and lower extremities; free-running emg, showing rare periods of nerve root irritation at the right l5 and s1 level; stimulus triggered emg did not suggest an increased likelihood of continuity between neural structures and surgical hardware or breach of central canal.(b)(6) 2008 the patient presented with complaints of dizziness and the patient was diagnosed with diarrhea, dizziness and possible medication withdrawal.(b)(6) 2008 the patient presented for follow up post right l5-s1 tlif.Impression: postoperative back pain, probably related to increased activity.(b)(6) 2008 the patient presented for clinical visit complaining of constant mid and lower back pain.Ap and lateral lumbar spine x-ray showed evidence of early though incomplete fusion at l5-s1, with good positioning of the interbody cage.Assessment: low back pain, lumbar radiculopathy.Medication: darvocet.(b)(6) 2008 the patient underwent mri lumbar spine w/wo contrast.Impression: post operative changes consistent with the history of l5-s1 right-sided discectomy and lateral fusion procedure.No evidence of recurrent disc herniation or neural impingement.(b)(6) 2008 the patient presented for clinical follow up right l5-s1 tlif.Impression: low back pain postoperatively; the patient was given rhbmp-2 intra-operatively, which was placed inside of the cage.Diagnostic imaging demonstrated a right l5-s1 foraminal stenosis secondary to overgrowth of rhbmp-2 stimulated ossification.(b)(6) 2008 the patient underwent ct lumbar spine wo contrast.Impression: status post l5-s1 fusion procedure with the right sided ha rdware in place and an intervertebral plug or spacer at the l5-s1 disc space; heterotopic bone formation posteriorly at the l5-s1 disc space which causes narrowing of the central canal in this location.There also appears to be a bone fragment or spur at the right superior articulating facet, and this causes narrowing of the right l5/s1 neural foramen; there does not appear to be complete bony fusion; right l5-s1 foraminal stenosis secondary to over growth of rhbmp-2 stimulated ossification.(b)(6) 2009 the patient presented complaining of low back pain, constant with radiating pain down the right leg.The diagnostic imaging demonstrated a right l5-s1 foraminal stenosis secondary to overgrowth of rhbmp-2 stimulated ossification.(b)(6) 2009 the patient presented complaining of right sided sciatica.Impression: right l5-s1 foraminal stenosis secondary to ectopic bone formation, post l5-s1 tlif.(b)(6) 2009 the patient presented with complaining of right-sided sciatica.Impression: right l5-s1 foraminal stenosis secondary to e ctopic bone formation, post l5-s1 tlif.(b)(6) 2009 the patient underwent lumbar mri and ct scans which demonstrated heterotropic bone formation extending posterior to the p reviously placed cage at l5-s1 with bone extending into the neural foramen causing stenosis and compression around the right l5 nerve root.Impression: 1.Right l5 radiculopathy secondary to heterotopic bone formation and foraminal stenosis at l5-s1.2.Low back pain.3.Degenerative disk disease of lumbar spine.4.Status post l5-s1 interbody fusion.(b)(6) 2009 the patient was presented with preop diagnosis of right l5-s1 foraminal stenosis due to heterotopic bone formation, status posts l5-s1 tlif with rhbmp-2.The patient underwent right l5-s1 re-exploration, micro dissection, and nerve root decompression.The previously healed incision was reopened and dissection carried medially over the lumbosacral fascia.The hyperesthetic bone material was removed as dissection was carried down towards the fused disk space.A rongeur was used to remove the remaining bone fragments of the nerve.A portion of inferior lamina of l5 was also removed using the 5mm coarse diamond bur.The l5 nerve root was adequately decompressed.The incision was closed and the patient was taken to a recovery room in a stable condition.(b)(6) 2009 the patient presented for follow up visit complaining of right sided leg paresthesias and low back pain.Impression: patient remains about the same with radicular leg pain following decompression.This is most likely associated with residual nerve root edema.(b)(6) 2009 the patient presented for follow up of right sided leg paresthesias and low back pain.Impression: patient residual nerve root edema has slowly resolved.(b)(6) 2010 the patient presented with bilateral lower extremity edema.Impression: 1.Edema unspecified.(b)(6) 2010 the patient presented for clinical follow up with increasing low back pain.Impression: increasing low back pain and sacral pain, etiology undetermined.(b)(6) 2010 the patient underwent imaging of lumbar spine before and after intravenous infusion of gadolinium.Impression: postoperative changes at the level of l5-s1 compatible with a right sided discectomy and lateral fusion procedure similar to the previous exam.There is no evidence of recurrent disc herniation or neural foraminal narrowing; bilateral ovarian cystic lesion.The lesion on the right appears to represent a simple cyst.The lesion on the left likely represents a hemorrhagic cyst; retroflexed uterus.(b)(6) 2010 the patient presented for follow up visit complaining of sacral pain and low back pain.Assessment: low back pain, abnormal mri of the sacrum with intrasacral lesion rule out neoplasm.(b)(6) 2010 the patient underwent limited bone scan of the pelvis and lower lumbosacral spine.A total of 29.1mci of technetium-99m mdp was used.Impression: minimal uptake in the right aspect of the l5-s1 interspace compatible with previous post surgical changes; no concerning foci of uptake identified in the pelvis or visualized lumbosacral spine.(b)(6) 2010 the patient presented for office visit with problems of low back pain, chronic.(b)(6) 2010 the patient presented with lower back pain.(b)(6) 2010 the patient presented with recurring back pain.(b)(6) 2010 the patient presented complaining of right ear ache and pain in right side of neck.Or pulmonary embolism.(b)(6) 2010, the patient presented for behavioral health session to address depressive/anxiety symptoms.Diagnostic impression: axis i: panic disorder without agoraphobia.(b)(6) 2011, the patient presented with fatigue, back pain while coughing.Impression: 1.Sinusitis.2.Lumbar disc degeneration.(b)(6) 2011 the patient presented with lower back pain.She also complained of anxiety attacks and shortness of breath, muscle cramps, stiffness and muscle aches.Impression: 1.Lumbar disc degeneration.2.Panic disorder without agoraphobia.(b)(6) 2011 the patient noticed blood in the urine and came to the hospital for an evaluation.She also complained of back pain.(b)(6) 2012 the patient presented with complaints of stomach pain, nausea and diarrhea.No evidence of acute disease with post operative changes in the lower lumbar spine.(b)(6) 2012 the patient presented with complaints of chest pain and some light headedness.She also reported occasional nausea.The etiology was uncertain.(b)(6) 2012 the patient reported lower back pain.(b)(6) 2013, the patient presented for follow-up and complained of having back pain, stiffness and jaw pain.(b)(6) 2014 as per billing records, patient underwent mri-spine, radiology.(b)(6) 2014 the patient underwent ct of the head due to history of head ache.Impression: normal ct scans of the head without contrast.(b)(6) 2014 the patient presented feeling very fatigued and swollen especially in legs.
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Manufacturer Narrative
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Review of radiographic images found as follows: (b)(6) 2005 lumbar ct scout view shows normal alignment without signs of fracture or disc space narrowing.Soft tissue and bony axial images are provided.No signs of stenosis, arthritis or disc herniation is noted except for l5.Small disc extrusion at l5 appears to displace the right s1 root very slightly.(b)(6) 2007 lumbar mri sagittal t1 and t2, axial t1 and t2 series are reviewed.Sagittal t2 show disc herniation at l5 with desiccation at this level.Axial view shows this to be an extruded fragmemt on the right impinging the right s1 root.Some early desiccation is seen at l4 as well with a very minimal bulge.No central stenosis is seen.Conus is at l1.(b)(6) 2008 chest x-rays pa and lateral views show some right lower lobe vascular prominence or scar.Lung fields, cardiac shadow, bony anatomy are otherwise normal.Spine is slightly hypo kyphotic.(b)(6) 2008 chest x-rays single ap view appears under penetrated.Small infiltrate may sit adjacent to the right heart border.Lung fields, cardiac shadow, bony anatomy and shoulders are otherwise normal.Chest ct spinal anatomy in the thorax appears normal.No signs of infiltrate are noted on these films.(b)(6) 2008 lumbar mri sagittal and axial t1 and t2 images are reviewed.Interval unilateral fusion has been performed at l5.Screws are present at l5 and s1 on the right with capstone peek spacer within the l5 disc space.Multiple axial studies show altered anatomy in the region of the capstone insertion track.Facetectomy has been performed.No recurrent hnp is noted.Artifact is found in and around the screws and rods in this area.(b)(6) 2008 lumbar ct heterotopic bone is now clearly seen surrounding the transitioning s1 root on three sides.The root is adjacent to new bone ventrally, dorsally, and laterally.The root is not displaced.Fusion is solid through the capstone.The heterotopic bone does not displace the l5 root, and appears to have formed around the s1 root without placing pressure upon it.(b)(6) 2009 sinus ct no spinal anatomy imaged (b)(6) 2010 lumbar mri sagittal and axial t1 and t2 images are reviewed.Unilateral fusion has been performed at l5.Screws are present at l5 and s1 on the right with capstone peek spacer within the l5 disc space.Bone is now clearly seen surrounding the transitioning s1 root on three sides as described on (b)(6) 2008.The root again does not seem compressed or displaced.The l5 root is not affected by the heterotopic bone.(b)(6) 2010 bone scan slight increased uptake is present at the level of fusion in l5.This is noted in both posterior and anterior imaging.The uptake is very slight.(b)(6) 2010 chest x-rays pa and lateral views show some right lower lobe vascular prominence or scar.Lung fields, cardiac shadow, bony anatomy are otherwise normal.Spine is slightly hypokyphotic.(b)(6) 2012 mammogram no spinal anatomy imaged (b)(6) 2012 mammogram no spinal anatomy imaged (b)(6) 2013 cervical x-rays lateral film shows flattened lordosis with focal kyphosis through c4/5.No evidence of surgery, fracture noted.Oblique views show fully open foramina.Ap and open mouth views show normal anatomy from c1 to t4.Mild arthritis is seen within the lateral masses of c1/2.(b)(6) 2014 cervical mri sagittal t2 images again show localized kyphosis from c4 to c6.No stenosis or hnp is noted.Desiccation of the disc from c2 to c6 is noted.Axial t2 images show flattening of the spinal cord at c4/5 and c5/6.(b)(6) 2014 head ct normal cranial contents without signs of trauma or tumor.C1/odontoid relationship is seen and appears normal.No other spinal anatomy imaged.(b)(6) 2014 head ct normal cranial contents without signs of trauma or tumor.C1/odontoid relationship is seen and appears normal.No other spinal anatomy imaged.
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