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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 7510400 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Chest Pain (1776); Diarrhea (1811); Dyspnea (1816); Edema (1820); Fatigue (1849); Headache (1880); Hearing Loss (1882); Neurological Deficit/Dysfunction (1982); Pain (1994); Swelling (2091); Tinnitus (2103); Weakness (2145); Tingling (2171); Stenosis (2263); Depression (2361); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544); 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 an extreme lateral interbody fusion at l3-l4 and l4-l5, using a competitor¿s cages and rhbmp-2/acs.The cages were placed into the respective disc spaces with rhbmp2/acs.Postop, the patient reportedly experienced pain.Reportedly, a ct scan revealed hypertrophic bone growth at the implant site, and the patient also reported experiencing retrograde ejaculation.
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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.(b)(4).
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Event Description
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It was reported that on, on (b)(6) 2009 the patient underwent muscle test two limbs, motor nerve conduction test, sense nerve conduction test.Impression : normal study of the lower extremities.No current evidence for lumbar nerve root injury, polyneuropathy or entrapment injury bilaterally.(b)(6) 2009, the patient presented with chief complaint of continued left lower back pain to lateral leg pain.(b)(6) 2009: patient underwent following pre-operative diagnosis: degenerative disk disease l3-4, l4-5, l4-5 greater then 3-4 with chronic debilitating back pain; sitting, standing intolerance; positive diskography with reproduction concordant pain at both 3-4 and 4-5.Patient underwent following operation: xlif l3-4 to l4-5 utilizing peek cages packed with demineralized bone matrix and bone morphogenic protein cellulose sponges fixed with lateral plates at both 3-4 and 4-5.Per op notes: surgeons made annulotomy followed by the cobb elevator to elevate the cartilaginous end plates on both sides from left to right.This was done completely through the contralateral annulus so as to in essence release the contralateral annulus.Having done this they then inserted the 8, 10 and then the 12 mm box chisels and they got a lot of disk material here.They retrieved it with pituitary rongeurs.They next inserted disk distractors, 8, 10 and 12 mm.They measured at 50 mm and then prepared a 50 mm x 12 mm peek cage that was packed with bmp-sponges and demineralized bone matrix.They next inserted this into the disk space after which they placed two screws cephalad and caudad to the disk space and attached these to a plate with its convexity anteriorly.The screws were roughly 60 mm long.They placed locking washers over the screws to keep the plates on, went up now and did the exact same thing at 3-4.Again they used a 14 x 50 rather than 12 x 50 peek cage at 3-4.They used a 12 mm plate at 3-4 again with 60 mm screws.Position was excellent.No patient complications reported.Other implants (other manufacture products) used: plates, screws, cages.(b)(6) 2009 patient was discharged.(b)(6) 2013, the patient presented with ear problem - right side "banging" noise; otalgia and underwent audiological evaluation.(b)(6) 2014:patient presented for office/outpatient visit.Patient presented with chief complaint of retrograde ejaculation.Neurological examination review: mental status, speech normal, alert and oriented x 3.Impression: retrograde ejaculation.
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Event Description
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It was reported that on, (b)(6) 2003: patient underwent x-ray of right knee.Impressions: his symptoms appear most consistent with torn medial meniscus of the right knee.This has really become noticeable more painful and limiting for him.On (b)(6) 2008 the patient presented with complaints of pain in left shoulder, bilateral hips, right wrist, and bilateral knees.Review of systems: fatigue, tinnitus, ear pain.The patient might have had element of osteoarthritis.
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Event Description
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It was reported that on (b)(6) 2009 the patient underwent x-ray of the lumbar spine.Findings: no acute fracture, dislocation or destructive process.Moderate disk degenerative changes are noted at l4-l5, and mild disk degenerative changes are noted at l4-l5, and mild disk degenerative changes were noted at l5-s1.No evidence of spondylolisthesis.During flexion and extension, no evidence was found of spinal instability.On (b)(6) 2009 , the patient presented with chief complaint of continued left lower back pain to lateral leg pain.The patient was diagnosed with : lumbago; lumbar disk without myelopathy; lumbar spinal stenosis; degeneration of lumbar intervertebral disks, multilevel; spondylosis, lumbar.On (b)(6) 2009 the patient presented with chief complaint of low back pain and left hip/buttock and leg pain.X-rays of the lumbar spine showed 5 lumbar vertebrae.He had substantial degenerative disc disease and probably some retrolisthesis at 4-5.He had disc space narrowing at 5-1, but looked to be more prominent at 4-5.The foramina on the sagittal image was severely compromised at 4-5.He had degenerative disc changes in the lower 3 discs.4-5 showed some early modic changes and endplate irregularities.On (b)(6) 2009 the patient presented for an office visit.Status post xlif, x-rays look great.He had a little nerve stretching.On (b)(6) 2011: patient went for an follow up with medications.On (b)(6) 2010, (b)(6) 2011,: patient presented with following diagnosis: major depressive disorder, recurrent, moderate to severe.
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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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(b)(6).It was reported that on (b)(6) 2009, the patient underwent xlif of spine at levels l3-l4 to l4-l5 due to significant low back pain and sciatica.The patient was implanted with nuvasive screw, nuvasive coroent implant x2,nuvasive xlp plate x 2, dbx putty transplant, apart from rhbmp-2/acs.Postoperatively, the patient suffered from following injuries: severe mid to low back pain.Right sided electrical shooting pain into feet, difficulty breathing due to stabbing pain in abdomen under rib cage, testicle pain, erectile dysfunction, irregular ejaculation possibly retrograde, extreme depression, severe problems sleeping, weakness in legs, instability during walking, cauda equina syndrome.Reportedly, these symptoms were experienced subsequent to rhbmp-2/acs surgery.The patient had no problems with sexual organ dysfunction prior to the surgery or difficulty breathing.The electrical sensation pain was not present.The patient had prior low back pain which necessitated the surgery but the degree of pain has increased and other symptoms above were either new or increased.2007- present: the patient was treated for following diagnoses: severe mid to low back pain.Right sided electrical shooting pain into feet, difficulty breathing due to stabbing pain in abdomen under rib cage, testicle pain, erectile dysfunction, irregular ejaculation possibly retrograde, extreme depression, severe problems sleeping, weakness in legs, instability during walking, cauda equina syndrome.Possibly in 2008-2009; (b)(6) 2011; (b)(6) 2012: the patient presented with back pain for surgical consultation.(b)(6) 2010- present: the patient underwent treatment for depression, anxiety and other mental health disorders.2015: the patient presented with back pain and surgical consultation regarding symptoms from his xlif with rhbmp-2/acs and possible fix for the damage.2014: the patient underwent treatment for urology and sexual disorder symptoms.2009, (b)(6) 2010, 2014: the patient consulted for back pain.2010, 2011: the patient was treated for back pain, neurologic deficits and pain.2012: the patient was treated for chronic pain.2009-2010: the patient was treated for tinnitus.(b)(6) 2013: the patient was treated for right ear pain.(b)(6) 2009: the patient underwent mri thoracic spine w/o contrast; mri lumbar spine w/o contrast due to back pain.(b)(6) 2010: the patient underwent x-rays of left and right hip due to hip pain and back pain.(b)(6) 2010: the patient underwent mri lumbar spine with and without contrast due to back pain.(b)(6) 2010: the patient underwent mri of cervical spine due to back pain.(b)(6) 2012: the patient underwent mri of lumbar spine without contrast due to back pain.(b)(6) 2012: the patient underwent mri of thoracic spine without contrast due to back pain.(b)(6) 2012: the patient underwent x-ray of chest due to chest pain.(b)(6) 2014: the patient underwent lumbar spine ct without contrast.The patient complained that he was unable to do most physical activities at all.He was limited in his ability to bath or move about his house at all.The patient laid down all day due to this pain.The patient was unable to do anything other than lay on the couch.Therefore any normal activities of daily life were restricted if not eliminated.The only other thing he sometimes did was ride or drive a car if needed but it was extremely difficult because he needed to change positions.On an unknown date in 2009 the patient underwent arthroscopy of the right and left knee and xlif spine surgery.On (b)(6) 2009 the patient underwent knee and left shoulder x-ray as per billing record.On (b)(6) 2009 the patient underwent mri as per billing record.On (b)(6) 2010 the patient underwent ump mri of cervical spine without contrast following neck pain and weakness bilateral arms.Conclusion: 1.Scattered changes of low- grade cervical spondylosis.2.At c4-c5, there is some left posterolateral interbody spurring with potential left c5 root.3.Mildy exaggerated cervical lordosis and upper thoracic kyphosis.On (b)(6) 2010 the patient presented with pain at posterior neck inferiorly in the midline and bilateral arm pain at trapezius area ( equal on the two sides).The patient also has pain in the upper back above the level of the shoulder blades in the midline; in the interscapular region in the midline; in the anterior, lateral, posterior and superior aspect of both shoulders; in the radial aspect of both forearms and numbness and tingling; volar and dorsal aspect of both wrists; and entire dorsal aspects of both hands and numbness and tingling.The patient presented with the following musculoskeletal diagnosis; gait: assisted gait, station is wide based, unsteady.Cervical spine: active rom limited with bilateral rotation.Lumbar spine: moderate low back pain in the midline for flexion and extension.Assessment: cervical disc degeneration, carpal tunnel syndrome.(b)(6) 2009 per the billing records, the patient underwent minimum 4 views of lumbar spine.(b)(6) 2011 per the billing records, the patient underwent ct head without contrast and chest 2 views pa and lat.
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Event Description
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It was reported that on (b)(6) 2012 patient complains of chest pain, shortness of breath, constipation, muscle weakness, neck pain, numbness/tingling.Impressions: back and leg pain.On (b)(6) 2012: mri of cervical, thoracic and lumbosacral spine were reviewed.Mri of cervical spine shows a lateral c-spine with mild disc bulge at c3-4, c5-6 but no evidence of neural compression.A lateral thoracic t2 weighted images were also obtained.Again, there are some moderate disc bulges but no evidence of substantial neural compression.This mr was dated (b)(6) 2012.Mri was also obtaining on (b)(6) 2012 of the lumbar spine.It shows the previous inter-body fusion at l3-4 and l4- 5.He has a lateral disc protrusion at l1-2 on the left.He has a central bulge at l2-3.There are post-operative changes at l3-4 with a central protrusion, post-operative changes at l4-5 and what appears to be a calcified disc protrusion at l5-s1 which is broad based and extends bilaterally.A post-gadolinium study shows his post-operative changes at l3-4 and l4-5.On the sagittal views, it appears as though the l3-4 cage may be posterior in the disc space.It appears as though it may even breach the annulus.His lumbosacral spine with bilateral leg pain, left more so than right, may be from the multi-level degenerative changes.On (b)(6) 2009: the patient underwent post discogram lumbar ct.Impression: post discogram limited ct.On (b)(6) 2009: the patient underwent lumbar, spine three views.Findings: three fluoroscopic spot images of the lumbar spine are submitted for interpretation.These demonstrate anterior spinal fusion at the level of l3-4 and l4-5 with instrumentation.The visualized portion of the lumbar spine is in anatomic alignment.On (b)(6) 2009 per billing records, patient underwent x-ray of lumbosacral region.On (b)(6)1984 the patient presented for psychiatric evaluation interview.Impression: rule out major depression, dependent personality, knife wound in abdomen.On (b)(6) 1986 the patient presented for psychiatric evaluation interview.Impression: adjustment reaction with mixed disturbance of emotions and conduct, dependent and highly impulsive traits, history of abdominal wound, stressor moderate to severe.On (b)(6) 1987 the patient presented for psychiatric evaluation.Patient had a history of unwise actions under the influence of alcohol.Impression: dysthymic disorder, mixed traits of personality disorder, remote history of skull fracture and urinary tract infection.On (b)(6) 2002, (b)(6) 2004, (b)(6) 2009 the patient presented for office visit.On (b)(6) 2009 the patient underwent muscle test two limbs, motor nerve conduction test, sense nerve conduction test.On (b)(6) 2011 the patient underwent muscle test for two limbs, sense nerve conduction test, motor nerve conduction test.On (b)(6) 2011, (b)(6) 2012, (b)(6) 2011, (b)(6) 2012, the patient underwent psychotherapy.On (b)(6) 1995 patient underwent x-ray examination of lumbar spine and pelvis.On (b)(6) 1999: patient presented for follow up visit.On (b)(6) 2010 patient presented for physical therapy evaluation.On (b)(6) 2010: patient presented for office/outpatient visit.On (b)(6) 2013 patient underwent ultrasound of abdomen.On (b)(6) 2014: patient presented for office/outpatient visit.On (b)(6) 2014, patient underwent extremity study.
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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) 2009: patient presented for evaluation of left shoulder and complained of bilateral knee pain and left shoulder pain.He had occasional symptoms in his knees, but these had always been mild.Patient stated in the last 6 months to 1 year, however his symptoms had worsened.He located the pain over his anterior medial knee.He described it as a sharp pain that sometimes felt like it was being dunked in cold water.Patient reported that the pain had caused him to fall down between 5 and 10 times in the past month.Impression: patient with bilateral medial meniscus tears with a history of previous bucket handle medial meniscus tears.Patient underwent left shoulder <(>&<)> bilateral knee x-ray.Impression: sagging acromion with marked subacromial space narrowing consistent with rotator cuff tendinopathy.Possible mild cuff arthropathy.Possible left fabella syndrome.Correlate clinically with left posterior knee pain.On (b)(6) 2009: patient presented with bilateral knee pain and catching.Outside mri did reveal evidence of recurrent tears of the medial meniscus degenerative in nature bilateral knees.Patient presented with pre-op diagnosis of bilateral medial meniscus partial tears.Patient underwent bilateral knee arthroscopies, partial medial meniscectomies.No complications reported.On (b)(6) 2009: patient presented for post-op office visit.Patient reported gradual improvement but was still significantly sore, part icularly with sitting for a long period of time.Patient stated having occasional sharp pain on the right anterior knee but denies any locking episodes.Generally, his pain had been achy in sensation and he had been taking occasional anti-inflammatory and icing.Impression: status post bilateral knee arthroscopies with medial meniscectomies.On (b)(6) 2010: patient presented for rheumatology consult with polyarticular joint pain and for diffuse large joint pains bilaterally.Initial impression : degenerative joint problems: shoulders, knees, hx back surgery; deconditioning; depression; chronic lack of restorative sleep, possibly due to depression, to reflux, or apnea (or mix of all three); risk for vitamin d deficiency.Diagnoses: old tear of cartilage or meniscus of knee; osteoarthritis, shoulder, left; pain in joint, hand; lumbago; pain in joint, lower leg; pain in joint, shoulder region.Assessment: osteoarthritis, shoulder, left.Bone pain.Screen-endoc/nut/met nec.Fatigue.Vitamin d deficiency.Hyperckemia.On (b)(6) 2011 the patient presented with the following diagnosis: hypopotassemia, hypokalemia, anxiety, fibromyalgia, nervousness, borderline diastolic bp, moderate elevation of systolic bp.Per the billing records, the patient underwent ct head without contrast due to headache and chest 2 views pa and lat due to weakness and tremors.Ct head impression: no acute intracranial abnormality.X-ray chest impression: no acute cardiopulmonary abnormality.On (b)(6) 2015:the patient complains of pain diagram is shaded all the way from his neck down the thoracic spine to the lumbar spine and up and down the front and back of the legs.He gets a stabbing pain in the chest at his costochondral junction.He has numbness and tingling in the left buttock and down the leg and 70% of the pain is in the back, 30% is in the leg.The patient's mri scan as well as a ct scan shows he is fused at l3-4 and l4-5.This appears to have been from a left lateral approach.The cage at the 3-4 level is in the posterior half of the disk space more central at the l4-5 level.He is collapsed at l5-s1 with bilateral l5 foraminal narrowing.He has loss of height at l2-3 as well.Notably, there is some bulging of the disk at s1 with some foraminal narrowing.There is perhaps some very mild loss of the subarachnoid space.On (b)(6) 2010, the patient visited the facility for pain assessment.Assessment : left acromioclavicular joint pain ; back pain (b)(6) 2010, the patient presented for medical assessment of his condition and x rays.Limited rom in right shoulder, hip pain, sharp pain in bilateral inner knees, and still the pain in his mid and upper back.Assessment : osteoarthritis.On (b)(6) 2010, the patient presented for follow-up of his back pain and pain in legs, knees and neck , had lump on back , hands swollen "curl up in the morning".Assessment : constipation ; lumbosacral disc degeneration.On (b)(6) 2010, the patient presented with following symptoms : not getting relief from pain , handicap parking pass, not sleeping.On (b)(6) 2011, the patient underwent laboratory test/examinations.On (b)(6) 2011, the patient was here for f/u of a stabbing pain in the right side of his rib area.Did x-ray, ekg, and labs.On (b)(6) 2011, the patient presented with multiple complaints , generalized joint pain, hand shaking, decreased hand strength, leg weakness edema to knee and thigh, chest pain that radiates from right side of chest to the left, lack of sleep due to pain.On (b)(6) 2011, the patient presented to discuss about medical issues.On (b)(6) 2011, the patient presented for esr , ra screening.Result : rf is normal.Still awaiting the (b)(4) test.On (b)(6) 2011, the patient presented for pain management and medicine refill.Assessment: vit d deficiency; arthralgias in multiple sides: chronic pain.Patient was prescribed for sed rate/ esr, rheumatoid factor hla - b27 assessment.Uric acid.On (b)(6) 2011, the patient presented for follow with medicines.On (b)(6) 2011 , patient presented for follow up of his meds.Would like to increase it to 3 patches.Need refills on all meds.On (b)(6) 2012 the patient visited for routine follow up and medication.On (b)(6) 2012, the patient presented for follow-up and underwent cbc , on (b)(6) 2012, the patient presented with urination problem , breathing difficulty and for general checkup (b)(6) 2012, the patient presented with diarrhea.On (b)(6) 2012, the patient presented with chronic lumbar disc degeneration.He was refilled for medicine.On (b)(6) 2013, the patient presented for follow up of his medication and pain , ear drop refills.On (b)(6) 2013 the patient was diagnosed for abdominal pain and lumbar disc degeneration.The patient underwent h pylortab , hepatic/liver function.(b)(6) 2014, the patient presented for complaining of back pain (b)(6) 2014, the patient presented for follow up of his medication and pain (b)(6) 2014, the patient presented with painful /burning urination and blood.(b)(6) 2014, the patient underwent urine dipstick examination.(b)(6) 2014, the patient presented for follow up of his medication and pain.(b)(6) 2014, the patient presented with swelling in right leg.The patient also requested for medicine refill.(b)(6) 2015, the patient presented for follow up and medicine refill.Assessment : lumbosacral disc degeneration (b)(6) 2015, patient visited the facility for pain management and requested medicine refill.
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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) 1985 the patient underwent x-ray of chest lateral view pre-op.Impressions: negative.On (b)(6) 1985 the patient presented with nasal fracture, nasal obstruction secondary to septal deviation and turbinate hypertrophy.The patient underwent nasoseptal reconstruction, bilateral partial inferior turbinectomy.Reduction and casting of nasal fracture.The patient tolerated the procedure well.On (b)(6) 1986 the patient underwent x-ray for chest lateral view.Impression: negative.On (b)(6) 2000 the patient came for an office visit due to shoulder pain.The patient was diagnosed with left shoulder stenosis.On (b)(6) 2002 the patient underwent mri-head only due to hearing loss which indicated of no evidence of an acoustic neuroma or other abnormality.On (b)(6) 2006 the patient underwent x-rays for chest pa and lateral views.Impression: no evidence of acute disease.Small portions of the costophrenic angles are cutoff from view on the lateral radiograph.On (b)(6) 2006 the patient underwent x-rays for left ribs unilateral views.Impression: no displaced fractures are seen.No lytic or sclerotic lesions are identified.On (b)(6) 2008 the patient underwent x-rays for left knee.Impressions: negative left knee.On (b)(6) 2008 the patient underwent x-rays ump of right wrist ap and lateral views due to distal ulna pain/rt forearm pain near wrist/cedarloo/(b)(6) 2008.Impression: normal right wrist.On (b)(6) 2008 the patient underwent mri ump for left shoulder / contrast due to joint pain left shoulder on the top/lt shoulder pain, weakness, limited rom, adhesion capsulitis.Impressions: supraspinatus tendinitis.Degenerative changes of osteoarthritis, glenohumeral joint.Inferolateral sloping of the acromion and probable small inferior spurs of acromion with narrowing of the acromiohumeral joint space.Also degenerative changes at the ac joint with mild impingement upon supraspinatus outlet.On (b)(6) 2009 the patient underwent mri ump for right wrist w/o contrast due to joint pain bilateral knees on inner side/right foramen pain near wrist.Impressions: there is tenosynovitis of the extensor carpi ulnaris tendon.There is some linear heterogeneous increased signal in its proximal portion suggesting possible partial tear.The other flexor and extensor tendons appear intact.No acute bony abnormality is noted.The ligaments of the wrist appear intact.On (b)(6) 2009 the patient underwent mri ump for left and right knee w/o contrast due to joint pain bilateral knees or inner side/right foramen pain near wrist.Impressions: tear, posterior horn, medial meniscus.Supporting ligaments intact.Small joint contusion.On (b)(6) 2009 the patient underwent mri ump mr spine lumbar w/o contrast due to back pain, degenerative disk disease.Impressions: there are multilevel degenerative changes with protrusion of disc material at more than one level along with facet arthropathy.As a result, there are changes of acquired spinal stenosis.On (b)(6) 2009 the patient underwent mri ump mr spine thoracic w/o contrast due to back pain, degenerative disk disease.Impressions: there is a degree of thoracic degenerative disc disease at more than one.No evidence for cord displacement.No evidence for vertebral compression.On (b)(6) 2009 the patient presented with spinal stenosis at l3-4.Per the billing records, the patient underwent minimum 4 views of lumbar spine, due to degen disc 1 spine, left leg radiculopathy.Findings: moderate disk degenerative changes are noted at l4-5, mild disk degenerative changes are noted at l5-s1.On (b)(6) 2009 the patient underwent x-rays ump spine lumbosacral 2 or 3 views due to back pain, s/p surgery ((b)(6)), cfp ((b)(6) 2009).Impressions: anterior fusion at l3-4 and l4-5.Moderate degenerative disk disease l1-2 l2- and l5-s1.No acute abnormality.On (b)(6) 2010 the patient underwent x-rays ump for left and right shoulder comp 2 views due to hip and shoulder pain.Impression: mild osteoarthritis at the glenohumeral joint and ac joint.No acute abnormality.Normal right shoulder.On (b)(6) 2010 the patient underwent x-rays ump for left and right hip comp 2 views due to hip and shoulder pain.Impression: very mild changes of osteoarthritis in left hip.No acute abnormality.Mild osteoarthritis in right hip.On (b)(6) 2010 the patient underwent ump mr spine lumbar w/o contrast usual due to back pain, disc degeneration and weakness in legs.Impressions: there has been surgical intervention with spinal fusion at l3 through l5 on the left.There are disk space prostheses evident at l3-4 and l4-5.Posterior disk protrusion on the left is again identified at l1-2.There is degenerative facet joint disease at more than one level with foraminal narrowing.A broad-based protrusion of disk material again identified at l5-s1 but this causes only minimal flattering of the thecal sac, and appears much as it did previously.There is moderate acquired foraminal narrowing bilaterally at this level.On (b)(6) 2011 the patient underwent chest x-ray.On (b)(6) 2011 the patient presented with the following diagnosis: hypopotassemia, hypokalemia, anxiety, fibromyalgia, nervousness, borderline diastolic bp, moderate elevation of systolic bp.Per the billing records, the patient underwent ct head without contrast due to headache and chest 2 views pa and lat due to weakness and tremors.Ct head impression: no acute intracranial abnormality.X-ray chest impression: no acute cardiopulmonary abnormality.On (b)(6) 2012 the patient underwent ump mr spine lumbar w/o contrast usual due to lumbosacral disc degeneration.Impressions: stable post-op changes, disc generation and posterior disc herniation with multiple levels of moderate foraminal and mild canal stenosis.On (b)(6) 2012 the patient underwent ump mr spine thoracic w/o contrast usual due to pain.Impression: degenerative disc disease and mild broad disc bulges in the cervical and thoracic spine.No high grade focal stenosis is detected.There is a large broad disc bulge at l1-2 and l2-3.On (b)(6) 2012 the patient presented with abdominal pain, constipation and hemorrhage.On (b)(6) 2012 the patient underwent ap supine and upright views of the abdomen with pa view of chest due to constipation.Impressions: moderate amount of stool in the colon could be due to constipation.No acute abnormality is detected in the chest.On (b)(6) 2014 the patient underwent ump ct scan spine lumbar w/o contrast due to back pain.Impressions: previous l3-5 spinal fusion with hardware.L1-2 level degenerative disc disease and moderate left subarticular spinal canal stenosis.L2-3 level degenerative disc disease and mild spinal canal stenosis.L3-4 and l4-5 level subarticular spinal canal and neural foraminal stenosis.L5-s1 level posterior disc protrusion and severe bilateral neural foraminal stenosis.On (b)(6) 1999 the patient presented with left knee pain and underwent x-rays of the left knee, three views which were normal.The clinical examination indicated that the patient lacks 10 degrees to full extension and lacks 20 degrees to full flexion.Full flexion was uncomfortable.Flexion rotation test was painful.Localized tenderness in the medial joint line, 3+.Medial collateral intact, lateral collateral intact.Lachman test negative.Pivot shift test negative.No clinical signs of patellar derangement.On (b)(6) 1999 the patient presented with left knee pain.Physical examination indicated difficulties with (b)(4) heel and toe walk due to pain in his left knee.The patient was diagnosed for medial meniscus tear left knee.The patient underwent operative arthroscopy and partial medial meniscectomy for left knee.Findings: undersurface of the patella was normal.Medial meniscus showed a horizontal cleavage ad longitudinal tear involving the posterior one-third of the medial meniscus.There was also a small flap at the posterior horn area of the medial meniscus.Anterior cruciate is normal.Lateral meniscus was normal.Articular surface of the lateral tibial plateau and femoral condyle is normal.Assessment: patient has average rom.Post-op diagnosis: longitudinal and cleavage tear, posterior one-third medial meniscus, left knee.On (b)(6) 2003 the presented with right knee pain.Assessment: right knee pain.The patient was diagnosed for medial meniscus tear right knee.The patient underwent right knee arthroscopy with partial medial meniscectomy.As per op notes, all compartments appeared excellent except of the medial compartment.There was a bucket handle tear displaced into the notch.This was reduced, sectioned posteriorly and then sectioned anteriorly and fragment removed.Margins were trimmed with the meniscotome.Post-op diagnosis: bucket handle tear of the right knee.On (b)(6) 2006 the patient presented with headache and left rib pain with tingling and numbness in the head.Impression: chest wall pain.On (b)(6) 2007 as per medical records, clinical impressions: surface assault.Scratched wrist.On (b)(6) 2008 the patient presented with left knee injury.Clinical impressions: assault.Knee injury.On (b)(6) 2008 the patient underwent x-rays for left knee following an assault.On (b)(6) 2008 the patient presented with shoulder pain.On (b)(6) 2008 the patient underwent mri ump of shoulder w/o contrast due to pain, weakness, limited rom, adhesion capsulitis.Assessment: joint pain in the left shoulder on the top.On (b)(6) 2009 the patient underwent mri ump for right knee w/o contrast due to joint pain bilateral knees or inner side/right foramen pain near wrist.Impressions: abnormal signal consistent with tear of medial meniscus probably involving the body of the meniscus as well as the posterior horn.The acl is small in caliber but appears to remain intact with no abnormal signal identified at its femoral or tibial attachments.The remaining supporting ligaments of the knee are intact.Small joint effusion.On (b)(6) 2009 the patient presented with his re-injured back.Active problems: adhesive capsulitis of shoulder, left, fatigue, joint pain in both knees on the inner side, joint pain in the left shoulder on the top, right forearm pain near the wrist, wrist injury.Assessment: back pain, tinnitus.On (b)(6) 2009 the patient presented with low back pain and lower extremity pain.The patient was diagnosed for: lumbago.Lumbar disk without myelopathy.Lumbar spine stenosis.Degeneration of lumbar intervertebral disks, multilevel.Spondylosis lumbar.On (b)(6)2009 the patient came for a follow-up of his pain management.On (b)(6) 2009 the patient presented with low back pain and underwent evaluation for transforaminal epidural steroid injections l4-l5 on the left side.Examination of lower extremities did not reveal any motor or sensory deficits.He was unwilling to stand on his toes and heels; however, lumbar flexion and extension both were suboptimal.The two ankles were difficult to elicit.Straight leg test was negative.He did have moderate paraspinal tenderness, which was equal bilaterally.There were no specific trigger points in paraspinal or quadrates lumborum muscles.The patient underwent mri.Impression: possible lumbar radicular symptoms secondary to spinal stenosis.On (b)(6) 2010 the patient was diagnosed for osteoarthritis on (b)(6) 2010 the patient was diagnosed for chronic pain, apnea.On (b)(6) 2010 the patient presented with complaints of constipation.On (b)(6) 2010 the patient was diagnosed for degeneration of lumbar disc.On (b)(6) 2010 the patient was diagnosed for cervicalgia.On (b)(6) 2012 the patient presented with severe back pain, nausea, vomiting and tremor.The patient was diagnosed with back pain.On (b)(6) 2012 the patient presented with an exacerbation of his back pain.Musculoskeletal examination indicates tenderness to palpation along left t-spine in area of t5/6/7.On (b)(6) 2012 the patient presented with low back pain that is chronic in nature.The pain radiates into bilateral legs, worse on the right.The patient reports difficulty urinating/starting urine stream.Musculoskeletal examination indicates tenderness to palpation of lumbar area.On (b)(6) 2012 the patient underwent ump mr spine cervical w/o contrast usual due to lumbosacral disc degeneration.On (b)(6) 2013 the patient was diagnosed for abdominal pain.On (b)(6) 2013 the patient was diagnosed for abdominal pain, right upper quadrant.On (b)(6) 2014 the patient was diagnosed for displacement of lumbar intervertebral disc without myelopathy, backache, unspecified, lumbosacral spondylosis without myelopathy, spinal stenosis, lumbar region, without neurogenic claudication, arthrodesis status.On (b)(6) 2015 the patient was diagnosed for failed back surgical syndrome.On (b)(6) 2011 the patient underwent multi-axial evaluation.Findings: major depressive disorder, recurrent, moderate severity; rule out posttraumatic stress disorder from childhood trauma.Diagnosis deferred but the patient has significant difficulties with trust because of his difficult early history.The patient describes having severe degenerative disc disease, osteoarthritis, pain in the back, shoulders, knees, hands, hips and neck, along with tinnitus and hearing loss.There is a past history of back surgery.He had an extreme lateral interbody fusion of l3-4 and l4-5.The patient has had gerd symptoms.He complains of headaches and pain that makes it difficult to catch his next breath.Severe economic, occupational and family stress.Current gaf= 55 severe symptoms.On (b)(6) 2015 the patient came for an office visit.
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Manufacturer Narrative
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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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Event Description
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It was reported that on, (b)(6) 2000: the patient presented with acute conjunctivitis.On (b)(6) 2009: patient complains of bowel and bladder issues post fall on ice which dissipated as inflammation in lower back gets controlled.Patient has had significant pain in the thoracic and lumbar regions with the lumbar pain being more severe and continuous.The pain in the lumbar (lower 5 inches) is constant and sometimes very sharp.It is more pronounced on the left side.The back and hip pain radiates down both legs to knees, again with the left side pain being significantly greater.The pain is continuous and punctuated by sharp and severe pain shooting down left leg; the epicenter of the pain seems to be hip (l).Patient get tingling, vibrating sensations in left back and leg usually to knee.Patient have to make frequent position changes to help alleviate the pain and sensations.For the last couple of weeks patient have been having the sensation of bumble bees crawling and buzzing on left leg (quad) laterally.Patient have other pain issues in my left shoulder, right wrist and both knees.On (b)(6) 2009: patient underwent discography due to degenerative disc disease, lumbar.Impressions: positive discography at l3-4 and l4-5; negative discography at l2-3 (b)(6) 2009: patient presented with chief complaint of low back pain.On (b)(6) 2012: the patient presented with corneal abrasion.
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