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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
Arthritis (1723); Bronchitis (1752); Chest Pain (1776); Cyst(s) (1800); Dyspnea (1816); Edema (1820); Hearing Loss (1882); Incontinence (1928); Muscle Spasm(s) (1966); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Pneumonia (2011); Swelling (2091); Weakness (2145); Tingling (2171); Hernia (2240); Depression (2361); Fasciitis (2375); Sore Throat (2396); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent an anterior lumbar interbody fusion at l4-s1 where rhbmp-2/acs was placed in the disc space.The patient's post-operative period was marked by a temporary relief from pain and subsequently marked by pain in her legs.The patient continues to experience pain that radiates into her lower extremities as well as numbness causing her difficulties ambulating.
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Manufacturer Narrative
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(b)(6).(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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Add'l info.
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Event Description
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It was reported that on (b)(6) 1975, (b)(6) 1977, (b)(6) 1978, (b)(6) 1980, (b)(6) 1981, (b)(6) 1982, (b)(6) 1984, (b)(6) 1985, (b)(6) 1986: the patient presented for an office visit.(b)(6) 1986: the patient underwent radiological examination of left knee post a fall.Impression: the bones and joints appear normal.(b)(6) 1986: the patient presented with follow-up of her left knee.She fell onto a piece of wood on (b)(6) 1986: the patient presented with acute otitis.She had painful ears bilaterally.(b)(6) 1986: the patient presented with pain on the right 4th toe.Assessment: possible flea bites.She also underwent unknown examination of toe of right foot.Conclusion: no fracture or dislocation noted.(b)(6) 1986: the patient presented with cough and sore throat.Assessment: urinary renal infection.(b)(6) 1987: the patient presented with bruised elbow.The patient fell landing on her right elbow.(b)(6) 1987: the patient presented with burned fingers.She burned her index and middle finger of the right hand on a soldering gun.(b)(6) 1987: the patient presented with vaginal itching and discharge.(b)(6) 1987: the patient presented with sore throat.She also vomited once two days back.Assessment: viral urinary renal infection.(b)(6) 1987: the patient presented with some bumps in the area of posterior fourchette.Observation: venereal warts.(b)(6) 1987: the patient presented two days post a car accident.She had fever and pain in the right upper quadrant.She also had loss of appetite.She also underwent unknown examination of flat and up abdomen.Conclusion: a few loops of small bowel noted in the right lower quadrant; there appeared to be partial sacralization of l5 and scoliosis to the right.(b)(6) 1988: the patient presented after getting hit by a car.X-ray showed a non-displaced radial styloid fracture intra-articular.Assessment: radial styloid fracture.(b)(6) 1988: the patient was diagnosed with fracture distal radius.(b)(6) 1989: the patient underwent "ob" ultrasound.Impression: normal ultrasound.(b)(6) 1992: the patient presented with ear aches.Assessment: left otitis media.(b)(6) 1993: the patient presented with severe left ear pain.Assessment: otitis media and external otitis.(b)(6) 2009 per billing records patient presented for an office visit.(b)(6) 2012 per billing records patient underwent bcx-ray breast bilat-intrerp.(b)(6) 2014: the patient presented with right vocal cord ulcer and necrosis.She also complained of left sided chest pain, which was getting worse.The pain worsened with a deep breath or changes in position (b)(6) 2014: the patient presented with chronic low back pain and newer symptoms of leg shaking.Impression: back pain; peripheral neuropathy; left shoulder pain.(b)(6) 2014: the patient presented with follow-up for pneumonia, shortness of breath and cough.Assessment: left rib fracture; cough; rib pain on the left side; nodule on left lung; chronic back pain.Fracture of a left rib laterally appearance most suggestive of the sixth rib but this is inconclusive.(b)(6) 2014: the patient presented with hematuria, dysuria and low back pain.The patient also had flank pain that radiated anteriorly on the right.Assessment: urinary problem; hematuria.
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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 on (b)(6) 2014: the patient underwent ¿cta chest pe run¿ due to chest pain.Conclusion: pulmonary angiogram is negative for embolus; indeterminate mildly enlarged right hilar node; prominent but subcentimeter left hilar nodes; mild paraseptal emphysematous changes in the upper lobes.She also underwent x-rays of the chest.Findings: negative chest.
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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 in (b)(6) 2007, the patient was diagnosed with back pain.On (b)(6) 2007: patient underwent lumbar mri due to right leg numbness and restlessness.Impression: small broad based central protrusion of the l4.On (b)(6) 2007: patient underwent right l4-l5 transforaminal epidural steroid injection using fluoroscopy, injection of contrast for ep idurogram and injection of anesthetic and steroid for diagnostic and therapeutic purpose due to lower extremity pain.No complications reported.Impression: technically successful right l4-l5 transforaminal epidural steroid injection.On (b)(6) 2008: patient underwent right l5-s1 transforaminal epidural steroid injection using fluoroscopy, injection of contrast for ep idurogram and injection of anesthetic and steroid for diagnostic and therapeutic purpose due to right low back pain.No complications reported.Impression: technically successful right l5-s1 transforaminal epidural steroid injection.On (b)(6) 2008: patient presented with back pain with numbness into the right leg with radicular leg pain and some weakness.Patient had off and on symptoms over the past ten years.She had tried steroid injections.She had some stress incontinence and urgency develop with her bladder, especially with being on muscle relaxants and pain medications, and after having two children.Her symptoms initially started in the right leg then moved to the lumbosacral area and then recently increased with the back pain.Her symptoms are severe with rest and with activity, constant in occurrence, and function is awful.She had tried decreased activity, ice and heat, therapy, chiropractic, and injections walking, climbing, lifting, sports, sitting at length, and sleeping all increase her symptoms.Patient x-ray showed a lytic isthmic spondylolisthesis at l5-s1 with foraminal stenosis.As well she has degenerative l4-5 spondylosis with a central disk prolapse.The more proximal levels appear to be well maintained.Impression: bilateral degenerative change, l4-5 and l5-s1.Lytic isthmic spondylolisthesis at l5-s1 with foraminal stenosis.Persistent back pain and leg pain despite injections, chiropractic therapy, ice and heat, and decreased activity.On an unknown date in (b)(6) 2008, the patient was diagnosed with back pain, degenerative disk disease.On (b)(6) 2008: patient presented with following diagnoses: degenerative disc disease with decision for anterior/posterior spinal fusion, anterior fusion l4-l5, l5-s1 spinal levels; l5-s1 lytic isthmic spondylolisthesis with instability and foraminal stenosis; l4-l5 spondylosis with retrolisthesis and instability.Patient underwent following operative procedures: anterior retroperitoneal exposure l4-l5, l5-s1 levels, anterior spinal fusion; anterior lumbar interbody fusion with femoral ring allograft and two 4.5 by 26 mm screws, harvest left anterior iliac crest for autograft, placement of a combination of stryker femoral ring allograft size 12 at l4-l5, size 14 at l5-s1, small rh-bmp2/acs divided in half at each level and an autograft harvest from the left iliac crest.Per op notes, a small rh-bmp2/acs had been opened.Mixtures of small rh-bmp2/acs as well as autograft was placed within the medullary canal of the allograft.Other quarter of the rh-bmp2/acs was placed along the lateral portions of the l5-s1 disc.This used one-half if the rh-bmp2/acs package for l5-s1.Some additional autograft was placed in the posterior lateral gutters and the graft was impacted with the new screw drive graft introducer.The disk space was trialed up to 12 mm and this allowed to regain the lordosis between l4 and s1, in addition to the lordotic reconstruction already done at l5-s1.One-half of the small rh-bmp2/acs was then split in thirds and one third was placed within the graft and two thirds were placed along the lateral margins of the disc space.Diagnosis: lytic isthmic spondylolisthesis with instability l5-s1, l5-s1 spondylosis with retrolisthesis and central disc hernia status post anterior lumbar interbody fusion.Implants used: pedicle screws.Posterolateral fusion with harvest left posterior iliac crest for bone graft.Bilateral l5-s1 foraminotomy with excision of osteocartilaginous debris and loose bodies from the foraminal zones.Bilateral posterolateral fusion intertransverse down to the sacral ala.Segmental instrumentation screws and hardware.Intra-operatively, patient underwent lumbar spine x-ray to confirm the hardware position.No complications reported.On (b)(6) 2008: patient presented for pain management.Assessment: continued post-operative pain at unacceptable level; restless leg syndrome; drowsiness in spite of pain.On (b)(6) 2008: patient presented for first post-op visit after undergoing anterior, posterior fusion l5-s1.Patient complained of fairly significant amount of incisional pain particularly over the bone graft sited both anteriorly and posteriorly.Impression: status post anterior, posterior fusion l5-s1 for lytic isthmic spondylolisthesis with instability.On (b)(6) 2008: patient presented for post-op follow up.X-ray showed good early incorporation of posterolateral and interbody fusion areas.On (b)(6) 2008: patient lumbar spine x-ray due to low back pain, status post surgery.Findings: there has been rod and screw fixation from l3 to the secrum along with interspace bone grafts at the l4-5 and l5-s1 levels.Two metallic fixation screws through the anterior upper sacrum.Vertebral alignment is near anatomic.Minimally narrowed l3-4 interspace.Probable bone graft along the posterior elements of the low lumbar spine.Surgical clips projected over the anterior low lumbar spine.On (b)(6) 2008: patient presented with increased pain.Postoperatively, she was weaning off of her pain meds and then fell down the steps at home.Plain x-rays showed intact maintenance of the interbody fusion, femoral rings and autograft at l4-5 and l5-s1.There is no lucency around the hardware.There is some evidence of developing posterolateral fusion masses from l4 to s1 but this has certainly been slowed by her continued tobacco abuse.Impression: chronic pain syndrome which was established preoperatively with a history of prior narcotic dependence for chronic pain.History of fall down the steps in september with a history of re-onset of some back pain without a radicular component.Sleep disturbance.Evidence of anxiety and depression.Continued heavy narcotic requirement per her complaints of pain.Patient underwent lumbar spine x-ray.Impression: no obvious abnormality in alignment in the lumbar spine in a patient status post anterior posterior fusion from l4 to s1.On (b)(6) 2008: patient underwent ct lumbar without contrast due to low back pain, bilateral leg numbness.Conclusion: post operative changes from l4 through s1 fusion using posterior rod and pedicle screw fixation as well as intradiscal fusion devices at the l4 and l5 interspace levels.The fusion hardware and intradiscal fusion devices appear in satisfactory position.There is very slight anterior subluxation of l5 on s1.This is related to chronic appearing bilateral spondylolysis at this level.Allowing for some artifact from fusion hardware, the central spinal canal in the lumbar region is adequately patent.Again allowing for some artifact, there is no definite evidence for significant neural foraminal narrowing on either side in the lumbar region including the l5-s1 level.Upper lumbar levels within normal limits· 6.Slight left lumbar curvature noted.On an unknown dates in 2009, the patient was diagnosed with back pain and underwent epidural injections.On an unknown date in 2012, the patient underwent bladder surgery.On an unknown date in 2013, the patient underwent hernia repair.On (b)(6) 2013: patient presented with the complaints of urinary frequency, urgency and mixed urinary incontinence.On (b)(6) 2013: patient presented for evaluation of a painful lump on her abdomen at the site of a previous surgery.On exam, it appeared to be an incarcerated incisional hernia just above her umbilicus.Assessment: incarcerated incisional hernia.No contraindication to surgery.Patient has chronic pain syndrome.Patient underwent probable repair of an incarcerated incisional hernia.No complications reported.On (b)(6) 2013: patient presented for recheck after urgent repair of an incarcerated partially obstructing incisional ventral hernia.On (b)(6) 2013: patient presented for urodynamic study.Pre-procedure diagnoses: urinary frequency, urgency and mixed urinary incontinence.Patient underwent following procedures: uroflowmetry.Sterile urethral catheterization for measurement of postvoid residual urine volume.Complex filling cystometrogram with measurement of bladder and rectal pressures.Complex voiding cystometrogram with measurement of bladder and rectal pressures.Electromyography of the pelvic floor during urodynamics.Fluoroscopic imaging of the bladder during urodynamics.Interpretation of urodynamics and fluoroscopic imaging.On (b)(6) 2013: patient presented with the complaints of urinary frequency, urgency and mixed urinary incontinence.Incontinence was associated with laughing, sneezing, coughing and bending at the waist.She had more than 10 episodes of incontinence per day.Patient had also issues with urge incontinence, of variable volumes.Assessment: patient with cystocele and rectocele as well as incomplete bladder emptying, urinary urgency refractory to 3 different anticholinergics and mixed incontinence.Patient also complained of back pain, right hip and leg pain which runs down sciatic to leg.On (b)(6) 2013: patient presented with incontinence for cystocele and rectocele repair.Pre-op diagnosis: cystocele, rectocele.Procedure performed: cardinal ligament and transobturator tfs u sling with anterior colporrhaphy and cystoscopy.No complications reported.Findings: grade ii cystocele, minimal rectocele.No stress incontinence after reduction of cystocele.On (b)(6) 2013: patient presented for post-op follow up.Patient reported doing well except immediately after surgery her urgency and frequency were gone but then about a week later she started to have it again.Patient also complained of some stress incontinence.On (b)(6) 2013: patient presented for post-op follow up.Patient reported that she was having a lot of incontinence that seemed to be mostly stress but could also be some urge.Assessment: s/p with some urgency and stress incontinence.On (b)(6) 2013: patient presented for pre-op review.Assessment: pre-op evaluation; stress incontinence; failed back surgical syndrome.As per evaluation, patient was cleared for surgery.On (b)(6) 2013: pre-op diagnosis: stress incontinence with some urgency; urethral hypermobility.Patient underwent release of previous u-sling, midurethral tfs sling and cystoscopy.No complications reported.On (b)(6) 2013: patient presented for post-op office visit.Patient reported that she was doing better, continued to have some urgency and urge incontinence but no stress incontinence.On an unknown date in 2014, the patient underwent throat surgery/ polyps removal.On (b)(6) 2014: patient underwent ct neck soft tissue with contrast due to worsening superior right vocal cord mass.Conclusion: asymmetric soft tissue thickening of the right true focal fold with loss of normal right paraglottic fat and a small amount of soft tissue crossing the midline to the left anteriorly.There is subtle asymmetric thickening of the right aryepiglottic fold as well.This is concerning for a laryngeal malignancy with possible supraglottic extension and correlation with findings on direct inspection of this region is advised.This abnormal soft tissue abuts the right thyroid cartilage without evidence for destruction.No definite enlarged cervical lymph nodes.Sub-centimeter right level ii and level iii lymph nodes are seen deep to the radiographic marker on the right.On (b)(6) 2014: patient underwent chest x-ray due to chest pain.Findings: shallow inspiration.Chest otherwise negative.On (b)(6) 2014: patient presented with chronic low back pain and newer symptoms of leg shaking.Diagnoses: back pain; peripheral neuropathy; shoulder pain, left; low back pain; s/p lumbar fusion.On (b)(6) 2014: patient underwent ct lumbar spine without contrast due to low back pain, bilateral leg pain, paresthesias and weakness.Conclusion: instrumented combined posterolateral and interbody fusion from l4 s1.There is solid bony bridging across both disc spaces as well as the posterior elements.Moderate bilateral facet osteoarthritis and disc degenerative changes at l3-l4, where there is slight degenerative retrolisthesis.No evidence for central canal stenosis.No high-grade foraminal stenosis.No disc protrusions are identified.Patient also underwent mri cervical spine with and without contrast.Conclusion: no evidence for extrinsic compression involving the cervical spinal cord.No abnormal cord gadolinium enhancement.No definite cervical cord signal abnormalities are identified.There is some motion artifact.Scattered spondylosis, including moderately severe left bony foraminal narrowing at c3-c4.On (b)(6) 2014: patient underwent chest x-ray due to chest pain.Findings: mildly displaced fracture through the left lateral appears to be sixth rib.No other rib fracture.Patient underwent unilateral ribs x-ray due to right rib pain.Findings: bb marker placed over the left lower ribs.Single minimally displaced fracture of a left rib laterally appearance most suggestive of the sixth rib but this is inconclusive.Since the rh-bmp2/acs surgery, the patient has been suffering from chronica back pain, neuropathy, hip and leg pain, and depression.Her symptoms also includes: chronic back pain, sciatica pain, pain in my right hip, and chronic pain down my right leg, along with some numbness in both legs; nerve damage in right leg and it has started to spread to left leg; depression.
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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) 2003: patient presented for office visit.Assessment: bronchitis with associated cough, nausea and vomiting.On (b)(6) 2004: patient presented for office visit with enlarging cyst in her left lower earlobe.Assessment: cyst left earlobe.Smoking cessation.On (b)(6) 2004, the patient presented for an office visit.Ros: fatigue, mild depression.On (b)(6) 2004 the patient presented with complaints of vomiting, epigastric discomfort and pain assessment: probable depression, fatigue.On (b)(6) 2005: patient presented for follow up with intermittent crampy abdominal pain and melena.On (b)(6) 2005: patient presented for follow up of colitis.Assessment: clostridium difficile colitis.Depression.On (b)(6) 2005: patient presented for follow up with chief complaint of ear infection in right ear.Assessment: right external otitis media.On (b)(6) 2005: patient presented for follow up with chief complaint of irritation in her eyes.Assessment: conjunctivitis (b)(6) 2006: patient presented for follow up with right ear infection.Assessment: right "om" improving, suspect component of eustachian tube dysfunction as well.On (b)(6) 2006: patient presented for follow up for bilateral plugged years.Assessment: eustachian tube dysfunction, post otitis media.On (b)(6) 2006: patient presented for follow up with cough and cold.Assessment: bibasilar pneumonia.Weight gain.Right hip pain.Irritable bladder.Patient under went right hip x-ray and lateral chest x-ray.Impression: x-rays show infiltrates bibasilarly.Right hip: the joint space is well maintained.Chest: some minor interstitial change in the left base consistent with interstitial pneumonitis.Rest of lung fields are clear.On (b)(6) 2006: patient presented for follow up with ear infection.Assessment: otitis externa of left ear with left middle ear effusion.On (b)(6) 2006: patient presented for follow up with right knee pain.On (b)(6) 2006: patient under went mri of the right knee.Impression: slight increased signal within the substance of the mid portion and posterior of the medical meniscus, a degenerative finding but no surface tear is visible.On (b)(6) 2007 the patient underwent x rays of the left ankle.No complication was reported.On (b)(6) 2007: patient presented for follow up with sprained ankle.Assessment: left ankle sprain.On (b)(6) 2007: patient presented for follow up with blood and cots in her stool.Assessment:hematochezia rule out clostridium difficile colitis, check stool for "o & p" clostridium difficile culture.On (b)(6) 2007 the patient underwent colonoscopy.Preoperative diagnosis: rectal bleed.Mild non specific colitis distal sigmoid colon to rectum.On (b)(6) 2007: patient presented for follow up.The patient is not feeling well.Assessment: colitis.Restless leg syndrome.On (b)(6) 2007: patient presented for follow up with continued leg pain.Assessment: sciatica (b)(6) 2007, (b)(6) 2008, (b)(6) 2009 the patient was presented for office visit with extreme back pain as well as leg pain.Herniated disc at l4 and l5.On (b)(6) 2007 the patient was presented for office visit with sciatica.On (b)(6) 2007: patient presented for follow up with back pain and right leg pain.Assessment: degenerative disc disease lumbar spine with, broad bases bulge at l4.Restless leg syndrome.On (b)(6) 2007 the patient was presented for office visit with low back pain with numbness down right leg.The patient underwent mri which revealed small broad based central protrusion at l4.On (b)(6) 2007: patient presented for follow up with back pain.Assessment: degenerative disc disease lumbar spine with radiculopathy.Depression.On (b)(6) 2007 the patient was presented for office visit with radicular low back pain on the right side of 6 weeks duration.She reported the low back calf as the area of pain.Diagnosis: herniated l4 disc manifested as radicular low back pain.On (b)(6) 2007 the patient was presented for office visit with low back pain.The patient received heat therapy, electronic stimulation, chiropractic adjustment and massage therapy.On (b)(6) 2007 the patient was presented for office visit with back pain.On (b)(6) 2007, the patient was presented for office visit with low back pain, numbness and left side of her back is starting to get sore.On (b)(6) 2007: patient presented for follow up with back pain.Assessment: degenerative disc disease lumbar spine with radiculopathy.Depression.On (b)(6) 2008: patient presented for follow up with back pain.Assessment: degenerative disc disease lumbar spine.On (b)(6) 2008: patient presented for follow up of low back pain and has concerns about bronchitis.Assessment: low back pain.Upper respiratory infection with cough.On (b)(6) 2008: patient presented for follow up with back pain.Assessment: low back pain.On (b)(6) 2008.The patient was presented for office visit.Diagnosis: herniated discs at the l4 and l5 and stress cracks in a vertebra.On (b)(6) 2008: patient presented for follow up of back problems.Assessment: degenerative disc disease lumbar.On (b)(6) 2008 patient disabled.On (b)(6) 2008: patient presented for follow up.Assessment: degenerative joint disease of the spine.On (b)(6) 2008: patient presented for office visit, pre-op for lumbar fusion.Assessment: diagnosis leading to surgery: degenerative disc disease and fracture.Patient requires no further work up prior to surgery.On (b)(6) 2008 the patient was presented for office visit with chronic back pain.On (b)(6) 2008 the patient was presented for office visit with herniated l5 disc with chronic pain, status post anterior-posterior l5-s1 fusion.Assessments: degenerative disc disease with chronic low back pain, status post anterior-posterior l5-s1 fusion.Urinary stress incontinence."ibs".Depression.On (b)(6) 2008 the patient was presented for office visit due to rehabilitation.On (b)(6) 2008 the patient was presented for office follow up on back surgery with back pain.Assessments: degenerative disc disease in lumbar region, status post fusion.On (b)(6) 2008: patient presented for post-op follow up.X-ray showed good early incorporation of posterolateral and interbody fusion areas.Assessments: low back pain status post fusion.On (b)(6) 2008: patient presented for office visit.On (b)(6) 2008: patient lumbar spine x-ray due to low back pain, status post surgery.Findings: there has been rod and screw fixation from l3 to the secrum along with interspace bone grafts at the l4-5 and l5-s1 levels.Two metallic fixation screws through the anterior upper sacrum.Vertebral alignment is near anatomic.Minimally narrowed l3-4 interspace.Probable bone graft along the posterior elements of the low lumbar spine.Surgical clips projected over the anterior low lumbar spine.The patient was also presented for office visit with back pain.Assessments: low back pain.Bronchitis with some bronchospasm.On (b)(6) 2008 the patient was presented for follow up on back surgery.Patient reported continued back pain.Assessments: low back pain status post fusion.On (b)(6) 2008 the patient was presented for office visit.Assessment: depression.Chronic low back pain, status posterior back surgery.Tobacco abuse.On (b)(6) 2008 the patient was presented for office visit with swollen legs and feet.Pain in right leg shooting down to foot.Impression: low back pain.On (b)(6) 2008, (b)(6) 2009 the patient was presented for office visit for physical therapy.On (b)(6) 2008 the patient was presented for office visit with back pain.Assessments: low back pain/ degenerative disc disease of lumbar spine.On (b)(6) 2009 the patient was presented for office visit with bronchitis, cold and sore throat.Assessments: bronchitis, possible sinusitis.Plantar fasciitis.On (b)(6) 2009 the patient was presented for office visit with leg pain and chronic back pain.On (b)(6) 2009 the patient underwent emg.Results indicated that there was some nerve damage in the right leg.The patient was presented for office visit for reassessment following her last clinic visit.Impression: chronic low back pain that appears myofascial in nature.On (b)(6) 2009 the patient was presented for office visit for pain management program.Diagnosis: failed back surgery syndrome in lumbar spine, chronic pain syndrome, depression, old right l5-s1 radiculopathy, generalized anxiety disorder, obesity, sleep disorder.On (b)(6) 2009: patient presented for follow up.Assessment: low back pain.On (b)(6) 2009 the patient was presented for office visit due to rehabilitation.On (b)(6) 2009 the patient was presented for follow up visit with back pain.On (b)(6) 2009 patient presented due to large cyst on bridge of nose.Assessment: sebaceous cyst.On (b)(6) 2009 patient presented due to back pain, pain medication not working.Assessment: chronic pain.On (b)(6) 2009 patient called to office due to medication not working.On (b)(6) 2009 the patient presented due to back pain, not sleeping.Assessment: failed back syndrome.On (b)(6) 2009 the patient was presented for office visit with chest pain.On (b)(6) 2009 the patient was presented for office visit due to rehabilitation re-evaluation.On (b)(6) 2009 the patient presented for an office visit.On (b)(6) 2009 the patient was presented for office visit.On (b)(6) 2009 the patient was presented for office visit due to rehabilitation re-evaluation.On (b)(6) 2009 patient presented due to chronic "ptsd", depressive disorder, adjustment disorder with mixed anxiety and depressed mood.On (b)(6) 2009 the patient was presented for office visit for primary care.Assessment: plantar fasciitis.Obesity.Constipation.Low back pain.On (b)(6) 2009 patient presented due to chronic "ptsd", depressive disorder, adjustment disorder with mixed anxiety and depressed mood.On (b)(6) 2009 patient presented for an office visit.On (b)(6) 2009 patient presented for an office visit due to low back pain, foot pain.On (b)(6) 2009 patient presented due to rehabilitation evaluation.On (b)(6) 2009 patient presented for an office visit due to hearing referral.Assessment: hearing loss, chronic back pain.On (b)(6) 2010 patient presented for an office visit due to back pain.Assessment: chronic back pain, depression, gerd.On (b)(6) 2010 patient presented due to rehabilitation evaluation.On (b)(6) 2010 patient presented due to chronic "ptsd" depressive disorder, adjustment disorder with mixed anxiety and depressed mood.On (b)(6) 2010 patient presented for an office visit.On (b)(6) 2010 patient presented for an office visit due to h1n1 influenza vaccination injection.On (b)(6) 2010 patient presented for an office visit due to depression.On (b)(6) 2010 patient presented for an office visit due to back pain.Assessment: chronic low back pain, depression.On (b)(6) 2010 patient presented for an office visit due back, right ear infection.Assessment: "hcm", chronic back pain, "om", acne, cystic.On (b)(6) 2010 patient presented for an office visit.On (b)(6) 2010: patient presented for follow up of chronic pain.Assessment: chronic low back pain with radiculopathy, failed back surgery.On (b)(6) 2010 patient presented for an office visit due to sore left shoulder.Assessment: l shoulder pain, depression.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2009, (b)(6) 2011 patient presented for an office visit.On (b)(6) 2010: patient presented for follow up.Assessment: low back pain with l5 radiculopathy.Depression.Bronchitis.On (b)(6) 2010 patient presented for an office visit due to "ddd" with fusion, depression, anxiety, obesity.Patient underwent ct of spine which showed spinal lumbar fusion surgery; minimal bulging at l3-4; fusion hardware; l5-s1 chronic bilateral spondylolysis, mild degenerative changes at the sacroiliac joints.On (b)(6) 2010: patient presented for follow up of back pain.Assessment: chronic back pain.Depression.Urge incontinence.On (b)(6) 2011 patient presented with chronic back pain/failed back surgery.On (b)(6) 2011 patient presented for an office visit due to medication refill.On (b)(6) 2011: patient presented for follow up of chronic pain.Assessment: chronic pain.Thorn finger.On (b)(6) 2011: patient presented for follow up of chronic pain.Assessment: chronic pain/failed back surgery.Reactive attachment disorder.On (b)(6) 2011: patient presented for follow up of low back pain.Assessment: low back pain restless leg syndrome.On (b)(6) 2011 patient presented for an office visit due to back pain.On (b)(6) 2011 patient presented for an office visit due to medication refill.On (b)(6) 2011: patient presented for follow up.Assessment: low back pain.Inflamed taste buds.On (b)(6) 2011: patient presented for follow up of chronic back pain.Assessment: low back pain.On (b)(6) 2012: patient presented for follow up of chronic pain.Assessment: low back pain.On (b)(6) 2012 patient presented for an office visit due to 섄d�depression, anxiety, obesity.On (b)(6) 2012: patient presented for follow up of back pain.Assessment: low back pain.On (b)(6) 2012: patient presented for follow up.Assessment: low back pain/failed surgery.Bronchitis.On (b)(6) 2012: patient presented for follow up of chronic back.Assessment: low back pain.On (b)(6) 2012: patient presented for follow up.Assessment: failed back surgery syndrome.On (b)(6) 2012: patient presented for follow up with chronic low back pain.Assessment: low back pain, incontinence.On (b)(6) 2012: patient presented for follow up with chronic low back pain.Assessment: low back pain, abdominal pain-ventral hernia vs diastasis.On (b)(6) 2012: patient presented for follow up with low back pain.Assessment: low back pain, incontinence.On (b)(6) 2012: patient presented for follow up.Assessment: low back pain.On (b)(6) 2012: patient presented for follow up.Assessment: low back pain.Insomnia.On (b)(6) 2012 patient underwent bcx-ray breast bilat-intrerp.Findings: no dominant masses, architectural distortion or suspicious calcifications are appreciated.Patient presented for follow up with chronic pain.Assessment: "hcm", cystocele with incontinence and constipation.Low back pain/failed back surgery.Cystic acne.On (b)(6) 2012: patient presented for follow up for medical check.Assessment: low back pain/failed back surgery.On (b)(6) 2013: patient presented for follow up with chronic low back pain and cough, sob, pain with deep breath.Assessment: failed back surgical syndrome.Acute bronchitis.On (b)(6) 2013: patient presented for follow up with chronic pain.Assessment: failed back surgical syndrome.On (b)(6) 2013: patient presented for follow up with increased pain in left knee.Assessment: failed back surgical syndrome.Left knee degenerative joint disease.On (b)(6) 2013: patient presented for follow up.Assessment: failed back surgical syndrome.On (b)(6) 2013: patient presented for follow up with problems with right knee.Assessment: spell of change in speech.Degenerative joint disease.Failed back surgical syndrome.Recurrent depression.Procedure: knee joint injection.On (b)(6) 2013: patient presented for follow up.Assessment: failed back surgical syndrome.On (b)(6) 2013: patient presented with tingling/numbness.On (b)(6) 2013: patient presented for follow up.Assessment: failed back surgical syndrome.On (b)(6) 2013: patient presented for follow up with issues with bladder control.Assessment: failed back surgical syndrome.On (b)(6) 2013: patient presented for follow up with increased pain and stiffness with weather.Assessments: failed back surgical syndrome.Asthma.On (b)(6) 2013: patient visited for follow up with spasms in right side lower back.Assessments: failed back surgical syndrome.On (b)(6) 2013: patient visited for follow up.Assessments: failed back surgical syndrome.Insomnia.On (b)(6) 2013, (b)(6) 2014: patient visited for follow up.Assessments: failed back surgical syndrome.On (b)(6) 2014: patient visited for follow up with laryngitis, sore throat and ear ache.Assessments: failed back surgical syndrome.Bronchitis.Abnormal ct lung screening.On (b)(6) 2014: patient visited for follow up with increased pain in right leg and increased numbness.Assessments: right lumbar radiculopathy.Failed back surgical syndrome.Ros: tingling/numbness.On (b)(6) 2014: patient visited for follow up for chronic low back pain.Patient continued to have tremors/shakes in right leg.Assessments: failed back surgical syndrome.On (b)(6) 2014: patient visited for follow up with worsening of voice.Assessments: failed back surgical syndrome.Hoarseness.On (b)(6) 2014: patient visited for follow up with chest pain and chronic back pain.Patient previously had presented to er with swelling in legs, more on left.Assessments: failed back surgical syndrome.On (b)(6) 2014: the patient presented with failed back syndrome.On (b)(6) 2014: patient visited for follow up with pain, cough, sob.Assessments: left lower lobe pneumonia, asthma, failed back surgery syndrome.On (b)(6) 2014: patient visited for follow up for chronic pain medications.Assessments: failed back surgical syndrome.Candida albicans infection.On (b)(6) 2014 presented for a follow-up.The patient complained of feeling warm a lot, sweating a lot, sometimes chilled and hair loss.Assessment: failed back surgical syndrome, moderate recurrent major depression, hair loss, heat intolerance, restless legs syndrome, gastroesophageal reflux disease, elevated blood sugar.On (b)(6) 2014 presented for a follow-up with recent abnormal lipids.Assessment: hyperlipidemia, failed back surgical syndrome.On (b)(6) 2014: patient visited for follow up.Assessment: failed back surgical syndrome, stress incontinence.On (b)(6) 2015: patient visited for follow up with sore on abdomen.Assessments: failed back surgical syndrome.Skin cyst.On (b)(6) 2015: patient visited for follow up with pain and some increase in numbness.Assessments: failed back surgical syndrome.Right lumbar radiculopathy.Restless leg syndrome.Chronic constipation.On (b)(6) 2015: patient visited for follow up.Assessments: right lumbar radiculopathy, failed back surgical syndrome, dependent edema, insomnia.On (b)(6) 2015: patient presented for office visit with pain and swelling.Assessment: failed back surgical syndrome, right lumbar radiculopathy, dependent edema.On (b)(6) 2015: patient presented for office visit.Assessment: restless legs syndrome, right lumbar radiculopathy, failed back surgical syndrome, high risk medication use.
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