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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
Device Operates Differently Than Expected (2913)
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| Patient Problems
Ossification (1428); Cyst(s) (1800); Hematoma (1884); Incontinence (1928); Muscle Spasm(s) (1966); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Vomiting (2144); Weakness (2145); Tingling (2171); Stenosis (2263); Shock, Traumatic (2268); Joint Swelling (2356); Numbness (2415); Neck Pain (2433); 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 a transforaminal lumbar fusion surgery at l5-s1 using an interbody cage and rhbmp-2/acs.The cage was placed into the disc spaced along with bmp.The bmp was also placed in the posterolateral aspects of the spine, bilaterally.Sometime postop, the patient began to develop radiating pain to his legs.The patient continues to experience pain.
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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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Event Description
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It was reported that the patient underwent a posterior lumbar fusion at l4-5, l5-s1 using rhbmp-2/acs.Following surgery, the patient had significant pain in the area of the fusion surgery and extremities.The patient underwent additional imaging that showed the patient had developed bony overgrowth, inflammation, osteolysis, and neuritis.Patient reportedly has received significant medical treatment to care for the injuries caused by the original fusion surgery.The patient reportedly has never recovered from the surgery, and continues to suffer from daily, disabling pain that prevents the patient from performing many basic activities of daily living.
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Manufacturer Narrative
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This mdr is being submitted late due to an fda outage.Additional information.
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Event Description
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It was reported that on (b)(6) 2015: the patient presented for an office visit due to motor vehicle crash.He complains of left lateral neck pain, and left pelvis and hip pain, and left upper leg region.He also had some scrapes on the hands.He stated that he had some glass in his mouth at the scene but spit that out.Patient underwent ct pelvis without intravenous contrast due to pain in hip radiating into mid left femur.Pain left lateral pelvis.No fractures were identified.Patient underwent ct of cervical spine without intravenous contrast due to pain in neck at shoulder level.Impressions: no cervical spine fracture present.Patient underwent x-ray of chest.Impressions: no acute cardiopulmonary abnormality is observed.Patient underwent ct head without intravenous contrast due to clinical history of trauma.Impressions: no acute intracranial abnormalities are identified.Discharge diagnosis: contusion of left hip, contusion of neck.Physical examination: left hip/pelvic tenderness with active and passive range of motion of the left lower extremity.
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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) 2015: patient underwent ct pelvis without intravenous contrast due to pain in hip radiating into mid left femur.Pain left lateral pelvis.No fractures were identified.Patient underwent ct of cervical spine without intravenous contrast due to pain in neck at shoulder level.Impressions: no cervical spine fracture present.Patient underwent x-ray of chest.Impressions: no acute cardiopulmonary abnormality is observed.Patient underwent ct head without intravenous contrast due to clinical history of trauma.Impressions: no acute intracranial abnormalities are identified.(b)(6) 2010: the patient was admitted with intractable back and leg pain and herniated disc.The patient underwent x-ray ap of chest.Impression: no acute cardiopulmonary process or significant change since the prior study from (b)(6) 2010.Probably one or two tiny granulomas at the left lung base.(b)(6) 2010 the patient underwent mri of lumbar spine due to lumbar hnp-pain progression.(b)(6) 2010 the patient underwent mri of lumbar spine w/o contrast due to low back pain,<(>,<)> intractable bilateral lower extremity.Impression: no significant change in the appearance of the lumbar spine when compared to (b)(6) 2010.There appears to be asymmetric lateral bulge/protrusion of the l5-s1 disc which exerts traction upon the proximal right l5 nerve root.This would be expected to result in unilateral radiculopathy.(b)(6) 2010 the patient presented with pre-op diagnosis of chronic back pain.The patient has a history of lumbar disc disease.Discharge diagnosis: back and leg pain secondary to right l5-s1 herniated nucleus pulposus.(b)(6) 2010 the patent underwent right l5 nerve root injection.No acute complications were encountered.(b)(6) 2010: assessment: right l5 radiculopathy secondary to far lateral herniated nucleus pulposus.(b)(6) 2010 the patient underwent x-ray of chest pa and lateral.Impression: negative chest.No significant change from previous exam ination.(b)(6) 2010 the patient presented with complaints of right hip and leg pain.He has had multiple lumbar epidural steroid injections and even a snsri.Mri of lumbar spine shows a far lateral herniated nucleus pulposus right l5-s1 herniated nucleus pulposus.Assessment: right l5 radiculopathy secondary to far lateral herniated nucleus pulposus.(b)(6) 2010: as per the billing records, patient diagnosed for lumbar hnp.Findings: a large contained herniated disc was identified and well decompressed during this procedure.No complications were noted.Post-op ros: numbness in right leg, painful lower back joint, painful right leg movement.(b)(6) 2010: as per the billing records, patient underwent low back disk surgery.Patient presented with recurrent right l5-s1 herniated nucleus pulposus.Procedure: repeat right l5-s1 partial hemilaminectomy, medical facetectomy and discectomy using the microscope for microdissection and the metrx retractor system for a minimally invasive approach and intraoperative fluoroscopy.Findings: recurrent disc herniation was identified and removed without difficulty.No complications were noted.Post-op ros: painful lower back movement.(b)(6) 2010: the patient presented with low back pain with right radicular symptoms.The patient underwent egd, flexible sigmoidoscopy, and tlif l5-s1.Discharge diagnosis: 1.Intractable back pain.2.Gastrointestinal bleed secondary to internal hemorrhoids.3, acute on chronic nausea and vomiting.4.Abdominal pain.5.Abnormal liver function studies.6.Depression 7.Marijuana use.8.Tobacco abuse.9.Recurrent diarrhea.No complications were noted.Impression: 1.Intractable right low back pain.2.Right leg numbness.10/06/2010 the patient underwent mri of lumbar spine w <(>&<)> w/o contrast due to low back pain.Impression: postsurgical changes of right l5-s1 laminectomy.(b)(6) 2010: as per the billing records, the patient was diagnosed for 1.Recurrent lumbar herniated disk.2.Intractable back pain.(b)(6) 2010 the patient came for an office visit for recommendations on his depression and anxiety.Impression: 1.Depression, not otherwise specified, rule out major depressive disorder and rule out depression secondary to medical-problems.2.Marijuana use.3.Dependent, narcissistic and obsessive traits.4.Back pain with disk disease.5.Rule out liver disease.6.Significant use of narcotics, but no withdrawal symptoms.7.Several stressors, does not have a job, got money problems, being evicted from his house on (b)(6) 2010, and girlfriend has left him, and states that he is really concerned about that he has got medical problems and how can he walk or function independently and no place to go and no one with him and he is quite scared and concerned and dealing with the medical problems and pain.8.55 currently due to his psychological problems as well as his medical problems.(b)(6) 2010 the patient underwent x-rays of lumbar spine.Impression: no evidence of significant post-procedural complication.No definite osseous fusion.(b)(6) 2010: patient underwent esophagogastroduodenoscopy with biopsy x1 and limited colonoscopy.Impression: normal upper endoscopy and normal limited colonoscopy.(b)(6) 2011 the patient presented with complaints of right leg and back pain.No signs of spinal or foraminal stenosis, disc herniation, obvious spondylitis, or unequivocal abscess.The presumptive fluid collection may exert minimal mass effect upon the right anterolateral margin of the thecal sac and it may also be exerting slight mass effect upon the exiting right l5 nerve root.(b)(6) 2011 the patient underwent ct of lumbar spine w/o contrast.Impression: posterior fusion with intervertebral body spacer l5-51, the hardware components are otherwise grossly unremarkable.Normal alignment for the operative level.Geographic lucent defect identified in the posterior portion of the l5 vertebral body predominantly right of midline with adjacent absence of focal posterior cortex, similar findings are also present for the superior suspect, right side l5.(b)(6) 2011 the patient presented with complaints of back pain.(b)(6) 2011 the patient presented with complaints of weakness in lower back, leg pain and numbness.(b)(6) 2011 the patient presented with complaints back pain.The patient was diagnosed for back pain, degenerative lumbar disc disease and intractable back pain.(b)(6) 2011 the patient presented with lower back spasms.(b)(6) 2011 the patient presented with complaints of back pain.The patient was diagnosed for incontinence and lumbar radiculopathy.(b)(6) 2011 the patient presented with the following postoperative diagnosis: right s1 radiculopathy.Procedure performed: re-exploration of spine fusion with a re-do laminectomy at l5-s1 with foraminotomies bilaterally and a posterior osteotomy on the right side of the pars as well as partial corpectomy on the right side using intraoperative microscope with full decompression of the right l5-s1 nerve root (b)(6) 2011 the patient presented with complaints of back injury.The patient was diagnosed status post (b)(6) 2011 for right s1 radiculopathy, low back pain.(b)(6) 2011 the patient presented with complaints of neck pain.(b)(6) 2012 the patient presented with complaints of back pain due to twisted back.(b)(6) 2012 the patient presented with active right thigh pain.The patient was diagnosed for l5-s1 radiculopathy.The patient underwent electrical stimulation, lontophoresis and isokinetic exercises.Therapeutic exercises.(b)(6) 2012 the patient presented with complaints of neck pain.(b)(6) 2012 the patient underwent mri of lumbar spine w <(>&<)> w/o contrast.Impression: no acute findings.Interval resolution of previous small right-sided posterior fluid collection at the operative site.No new focal disc herniation or protrusion is seen.There is no significant central canal stenosis.Post-surgical changes are stable.(b)(6) 2012 the patient underwent x-ray of lumbar spine due to back pain.Findings: previous posterior pedicle fusion at l5-s1 is stable.Alignment is normal without acute fracture or subluxation.Visualized pedicles are intact.(b)(6) 2012 the patient presented with complaints of back pain.(b)(6) 2013 the patient underwent ct of lumbar spine w/o contrast.Impression: 1.No acute findings.2.Relatively stable post-surgical changes at l5-s1.(b)(6) 2013 the patient presented with bowel blockage/vomiting/dehydration; underwent x-ray of abdomen due to constipation.Impression: stool is present throughout the colon with very minimal distension.This could represent constipation in the appropriate clinical setting.The bowel gas pattern otherwise is unremarkable.(b)(6) 2013 the patient presented with complaints of bilateral leg pain and extremity weakness.Ros: positive for back pain and extremity weakness.Neurological review: positive for weakness and numbness (legs r>l).
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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) 2014, the patient came for an office visit with complaint of low back pain and right leg pain also states he has notice dark red blood in stool for about 2 weeks.Musculoskeletal review indicates fairly normal gait but guarded due to the back pain.Neurological review indicates decreased sensation to lt in the rle compared to the lle.Assessment: dx of ptsd, dx of low back pain, chronic dx of degenerative disc disease, dx of hemoccult positive stool, dx of hemorrhoids.On (b)(6) 2014, the patient presented with pain located in his right lower back with radiation to his hip and upper leg.The patient was diagnosed for disc degeneration, lumbosacral.The musculoskeletal review indicated pain with rom reduced, extension>flexion, ttp in lumbar paraspinal muscles, faber negative bilaterally.Neurological review indicated sensory decreased in right lateral lower leg.On (b)(6) 2014, the patient came for a follow-up visit for chronic medical conditions.Musculoskeletal review indicated normal gait and station without limp or other asymmetry moving more freely today.Assessment: assessed hypertriglyceridemia, assessed low back pain unchanged- controlled and now seeing pain management, chronic, assessed hemorrhoids-as improved, dx of hypertriglyceridemia.On (b)(6) 2014, the patient presented with a complaint of low back pain.The patient was diagnosed for disc degeneration, lumbosacral, failed back syndrome and lumbar spondylosis.The musculoskeletal review indicated pain with rom reduced, extension>flexion, ttp in lumbar paraspinal muscles, faber negative bilaterally.On (b)(6) 2014, the patient came for a follow-up on medications.Assessment: assessed low back pain, chronic, assessed degenerative disc disease, assessed folliculitis-healing, dx of folliculitis.On (b)(6) 2014, the patient came for an office visit due to rash on arms.Assessment: assessed folliculitis-as worsened.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Preoperative diagnosis: herniated disk (summer 2010) it was reported that the patient underwent transforaminal lumbar interbody fusion on (b)(6) 2010 using rhbmp-2/acs and spinal system, 10 x 26 cage.Post-op, reportedly, the patient had serious nerve damage.He was confined to a wheel chair for three years and could not stand or walk.In addition, he had post traumatic stress disorder, emotional trauma, and had to see a psychologist.The patient was reportedly forced to take many medications with numerous negative side effects.The patient also stated that his pain never completely dissipated after the surgery, and started worsening within 2-3 months following that procedure.The patient also complained of experiencing chronic pain.He had weakness in my right leg and spasms.The patient had following treatments, procedures and diagnoses: (b)(6) 2003: ct, mri of lumbar spine (b)(6) 2010: the patient had lumbar epidural steroid injection.2008-2010: stomach issues, common cold.2010-2011: herniated disk spinal surgeries.On (b)(6) 2011: re-exploration of spine fusion with re-do laminectomy at l5-s1, due to back pain.2011-2012: lower back pain, right leg pain and weakness (b)(6) 2013: backache, disturbance of skin sensation (b)(6) 2014: pain located in right back with radiation to hip and upper leg.(b)(6) 2010: depression and anxiety 2011: pain management (b)(6) 2013: t10 laminectomy with implantation of spinal cord stimulator due to back pain.On (b)(6) 2013: radiology, pain medication due to back pain.On (b)(6) 2013: consultation due to back pain.On (b)(6) 2014: back pain (b)(6) 2010: egd summer 2014: pain, psychology (b)(6) 2014:er for right leg pain (b)(6) 2015: lumbar myelogram (b)(6) 2015: er- neck, back pain (b)(6) 2015: admitted after car accident, shoulder pain and knee pain.In (b)(6) 2015-present: back pain.
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Event Description
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It was reported that on (b)(6) 2012: patient presented with back pain and right leg, pain that is a stabbing type pain in his right lower back, radiating around to his leg.Diagnosis: acute on-chronic back pain.On (b)(6) 2015: patient underwent ct of thoracic spine due to spine pain radiating into groin.Impression: mild canal stenosis due to central protrusion at the t10-11 level.Otherwise essentially unremarkable exam with no acute abnormalities.On (b)(6) 2015: the patient presented for an office visit due to motor vehicle crash.He complains of left lateral neck pain, and left pelvis and hip pain, and left upper leg region.He also had some scrapes on the hands.He stated that he had some glass in his mouth at the scene but spit that out.Patient underwent ct pelvis without intravenous contrast due to pain in his hip radiating into mid left femur.Pain left lateral pelvis.No fractures were identified.Patient underwent ct of cervical spine without intravenous contrast due to pain in neck at shoulder level.Impressions: no cervical spine fracture present.Patient underwent x-ray of chest.Impressions: no acute cardiopulmonary abnormality is observed.Patient underwent ct head without intravenous contrast due to clinical history of trauma.Impressions: no acute intracranial abnormalities are identified.Discharge diagnosis: contusion of left hip, contusion of neck.Physical examination: left hip/pelvic tenderness with active and passive range of motion of the left lower extremity.
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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) 2011 patient reported low back pain, right leg pain and weakness.As per the billing records, patient underwent x-ray of the lower spine.Imaging results indicated spinal lumbar cyst, stable flexion and extension.On (b)(6) 2011 the patient called and reported that his pain level went from 7-8 to a 10 and he cannot bend or sit at times, also complaint of left sided pain in addition to right side.On (b)(6) 2011, the patient came for follow up for right leg numbness and left sided muscle spasms.Patient was diagnosed with lumbar ra diculopathy.On (b)(6) 2012: the patient presented with complaint of back pain.On (b)(6) 2012, the patient called to complaint of his low back and right leg pain.The patient reported that he was unable to sleep.On (b)(6) 2012, the patient was admitted to er on previous night with increasing right leg pain and numbness.On 2012 the patient called to complaint of his low back and right leg pain.On (b)(6) 2013 patient underwent ct of lumbar spine post myelogram due to new bilateral l2 and s1 radiculopathy.On (b)(6) 2015 the patient presented with chief complaint of back pain and burning sensation.Diagnoses of the visit: cellulitis, failed back syndrome, lumbar; migration of spinal cord stimulator, spinal cord stimulator dysfunction.The patient underwent x-ray of the thoracic spine.Impression: no discontinuity of spinal cord stimulator.The patient also underwent x-ray of the abdomen.Impression: no evidence of fractured leads or discontinuity of the spinal cord stimulator device.The patient also underwent x-ray of the lumbosacral spine due to lumbar midline tenderness and history of fusion.Impression: posterior fusion of l5 on s1 with no fracture or misalignment of the lumbar spine.The patient underwent x-ray of the thoracic spine due to lower thoracic midline tenderness.Impression: unremarkable examination of the thoracic spine.The patient also underwent various laboratory tests.25 nov 2015 the patient presented for an office visit with complaint of increased back pain.The patient underwent limited abdominal ultrasound.Impression: no soft tissue edema, hyperemia, focal fluid collection or well defined mass.On (b)(6) 2015 the patient presented for an office visit with complaint of increased back pain.On (b)(6) 2016 the patient presented for an office visit with chief complaint of pain and underwent laboratory tests.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Per medical records, it was reported that on, (b)(6) 2011 the patient was status post discectomy and underwent x-rays of the lumbar spine.Impression: intact hardware of posterior fusion of l5 to s1 with no acute lumbar spine abnormality.On (b)(6) 2011 the patient presented with a history of prior surgeries and underwent mri of the lumbar spine due to severe back pain radiating to the left lower extremity.Impression: post-surgical changes of prior discectomy at l5-s1 and posterior fusion of l5-s1 with pedicle screws and connecting rods.Some cystic changes are noted in the posterior inferior aspect of the l5 vertebral body with a cystic structure extending through the right posterolateral aspect of the disc space and into the right lateral recess and right l5-s1 neural foramen.There is some associated narrowing of the right l5-s1 neural foramen with some mild mass effect on the right l5 nerve root.Apparently the patient's symptoms are on the left.There are no abnormalities of the left side of the spinal canal at any level.The cystic structure on the right may represent some type of synovial line cyst or ganglion cyst.On (b)(6) 2012 the patient underwent x-rays of the lumbar spine due to back pain.Impression: posterior spinal fixation of spine without fracture or loosening.On (b)(6) 2012 the patient underwent lumbar myelogram due to right leg radicular pain; history of low back pain; previous surgery.Impression: postop changes at l5-s1.2, mild broad base disc bulge at the l4-l5 level.The patient underwent ct lumbar myelogram due t o right leg numbness, progressive with radiculopathy.Impression: post-surgical changes at l5/s1.Right paracentral disc osteophyte complex at l5/s1 that extends into the right foramen.Impingement is likely in this region.(b)(6) 2013 the patient presented with abdominal pain, nausea, vomiting and underwent ct of the abdomen and pelvis.Impression: no clear ct evidence cause for patient's presentation; few mildly prominent lymph nodes in the mesentery, non specific; no evidence of significant bowel obstruction; no evidence of significant hydronephrosis or obstructing renal calculi; no evidence of significant biliary ductal dilation; cholecystectomy clips; no evidence of appendicitis; small cyst medial aspect left kidney; posterior spinal fusion hardware.On (b)(6) 2013 the patient presented with back pain and underwent lumbar myelogram.Impression: successful lumbar puncture with contrast instillation for lumbar myelography and myelographic ct.Ap and lateral views of the lumbar spine performed for limited myelogram demonstrate the patient has had previous posterior fusion from l5-s1 with poor visualization of the contrast column beneath the level of surgery.Disc fusion also occurred at l5-s1 as well.There is mild ventral extradural defect phenomenon demonstrated at l3-4 and l4-5 with minimal canal stenosis suggested at l4-5.No evidence of dural root sleeve cutoff at the l4-5 level cephalad.Also the patient underwent ct lumbar myelogram.Impression: right l5 neural foraminal stenosis secondary to osteophytes off the adjacent l5 and s1 endplates, directed postero laterally to laterally on the right.Similar findings were present previously.On (b)(6)2015 the patient presented with history of lumbar radiculopathy and underwent lumbar contrast injection subsequent lumbar myelogram.Impression: successful lumbar puncture and contrast instillation for lumbar myelogram and lower myelographic ct.The myelogram demonstrates evidence of prior fusion at l5-s1 both posteriorly as well as disc fusion hardware at the disc space at l5-s1 as well.There is poor mixing of contrast at the l5-s1 level.The l1-2, l2-3, l3-4, and l4-5 levels are grossly unremarkable without evidence of extradural filling defect or concentric contrast column narrowing/stenosis.No nerve root sleeve cut off from l1-2 to l4-5 level.Spinal stimulator in place.Also the patient underwent lumbar myelographic ct study.Impression: status post posterior fusion at l5-s1 level with pedicle screws and rods.There are also post laminectomy changes as well as disc fusion hardware present at l5-s1.No evidence of recurrent/residual disc herniation or canal stenosis.Minimal disc bulging at l4-5 abutting the thecal sac without significant canal stenosis.Otherwise negative lumbar spine myelographic ct.On (b)(6) 2015 the patient underwent rf thoracic myelogram due to spine pain radiating into groin.Impression: technically successful myelogram.Also the patient underwent ct of the thoracic spine.Impression: mild canal stenosis due to central protrusion at the t10-11 level.Otherwise essentially unremarkable exam with no acute abnormalities.On (b)(6) 2015 the patient presented with history of motor vehicle collision and underwent left clavicle study.Findings: two views of the left clavicle demonstrate no evidence of fracture or dislocation.The patient underwent x-rays of the lumbar spine.Impression: no fracture or subluxation of the lumbar spine with changes of previous lumbosacral fusion at l5-s1 with pedicle rods and screws as well as disc fusion hardware in place.Spinal stimulator also in place with tip beyond the field of view.Prior cholecystectomy.Also the patient underwent x-rays of the knee.Impression: two views of the left knee demonstrate no evidence of fracture or dislocation.Also the patient underwent x-rays of the right hand.Impression: three views of the right hand demonstrate no evidence of fracture or dislocation.On (b)(6) 2010: the patient presented with lower back pain radiating down both thighs.He also complained of numbness.On (b)(6) 2010: the patient was admitted with intractable back and leg pain.On (b)(6) 2010: the patient presented with lumbar herniated nucleus pulposes, lumbar radiculopathy.On (b)(6) 2010: the patient presented with low back pain with right radicular symptoms.On an unknown date in 2011, the patient underwent spinal fusion l5-s1.On (b)(6) 2011: the patient was diagnosed with lumbar radiculopathy, back pain status post lumbar fusion.On (b)(6)2012 the patient also underwent ct of abdomen and pelvis due to abdominal pain.Impression: few mildly prominent lymph nodes in the mesentery.No evidence of significant bowel obstruction.No evidence of significant hydronephrosis or obstructing renal caculi.No evidence of significant biliary ductal dilation.Cholecystectomy clips.No evidence of appendicitis.Small cyst medial aspect left kidney.Posterior spinal fusion hardware.On (b)(6) 2012: the patient was diagnosed with cervicalgia, lumbar postlaminectomy syndrome, chronic pain syndrome, lumbosacral neuritis and brachial neuritis.On (b)(6) 2012: the patient presented with low back pain with lower extremity weakness.On (b)(6) 2012: the patient presented with chronic back pain.On (b)(6) 2012: the patient presented with complaints of back popping and legs buckling.On (b)(6) 2010: patient presented with mild tenderness on palpation over the right sacroiliac joint.On (b)(6) 2010: patient presented with recurrence of lower back pain, numbness of his thighs, tenderness on palpation over the sacroiliac joint.On (b)(6) 2010: patient underwent mri.Impression: far posterolateral disc bulge at l5-s1 on the right which may cause some compression or lateral displacement of the right l5 nerve root.Mild diffuse disc bulge at all lumbar disc levels as discussed above.Mild narrowing of the neural foramina bilaterally at l4-l5 related to disc bulge.On (b)(6) 2010: patient presented with pain in the lower back.Patient has had lower back pain for years.Patient underwent an mri which shows some very mild changes in the signal at the 5-1 disc.Impression: diffuse syndrome of pain, focused a bit on his lower spine.On (b)(6) 2010: patient presented with low back pain, back: some tenderness over the right sacroiliac joint.On (b)(6) 2010: patient presented with right hip and leg pain.Back: reduced range of motion in all cardinal planes tested, positive right slrt.On (b)(6) 2010: patient presented with right hip and leg pain.On (b)(6) 2010: patient presented with lumbar disc disease, recurring low back pain radiating into both thighs and numbness.On (b)(6) 2010: patient presented with low back pain, back: some tenderness over the right sacroiliac joint.On (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6)2011, (b)(6) 2011, (b)(6) 2012, <(>&<)> (b)(6) 2012: as per the billing records, patient presented for an office visit.(b)(6) 2011: patient presented with chronic pain syndrome, back pain.(b)(6) 2011: patient presented with joint swelling, back pain.On (b)(6) 2011: patient presented for med refills regarding pain, back pain, chronic pain syndrome.Patient underwent x ray of abdomen.Impression: evidence for hardware is seen.On (b)(6) 2011, (b)(6) 2011: patient presented for med refills regarding pain, back pain.On (b)(6) 2011: patient presented today with follow up back pain.He states that he continues to have pain in his back.On (b)(6)2011: patient presented with back pain.On (b)(6) 2011: patient underwent x-ray of the lumbar spine.Impression: status post l5-s1 fusion is seen.Patient presented back pain, chronic pain syndrome.On (b)(6) 2011: patient presented with leg weakness and right sided pain.Patient underwent mri lumbar w/wo contrast.Impression: post op scar at l5-s1 with cystic change of the posterior vertebral body and a possible ganglion extending into the lateral recess on the right compressing the exiting nerve root.On (b)(6) 2011: patient presented with back pain patient having muscle spasms, chronic pain syndrome, back pain.On (b)(6) 2011: patient presented back pain, right leg numbness, and chronic pain syndrome.On (b)(6) 2011: patient presented back pain, chronic pain syndrome.On (b)(6) 2011: patient presented back pain, diarrhea, nausea with vomiting.On (b)(6) 2011: as per the billing records, patient underwent x-ray of the lower spine.On (b)(6) 2011: as per the billing records, patient underwent osteotomy cervical spine, explore spinal fusion, laminectomy.On (b)(6) 2011: patient underwent x-ray of the spine lumbar.Impression: lumbar fixation with hardware in place.Patient presented with follow up back surgery, back pain.On (b)(6) 2011: patient presented for med refills regarding pain, back pain, chronic pain syndrome, muscular weakness, muscle cramps.On (b)(6) 2011: patient presented with neurosurgery follow up.Patient presented with postoperative diagnosis: right si radiculopathy.P rocedure performed: re-exploration of spine fusion with a re-do laminectomy at l5-s1 with foraminotomies bilaterally and a posterior osteotomy on the right side of the pars as well as partial corpectomy on the right side using intraoperative microscope with full decompression of the right l5-s1 nerve root.On (b)(6) 2011: patient presented with recheck back pain and medications, continues to have some pain local to the incision, and attention deficit disorder with hyperactivity.On (b)(6) 2011: patient presented for med refills regarding pain, back pain, chronic pain syndrome, and attention deficit disorder with hyperactivity.On (b)(6) 2011: patient underwent mri of lumbar spine w/wo/c.Impression: 1) there are artifacts related to the pedicle screws at the l5-s1 level.This likely contributes to the bone marrow signal about the l5-s1 disc space.There is mild diffuse disc bulge at l1-l2, l2-13, l3-l4 and l4-l5.There are postsurgical changes at 1.5-31.The fluid collection seen posterolaterally on the tight in the region of the disc and the vertebral body and extending from the disc now appears to extend posterolaterally into the parespinous soft tissues.There is high signal compatible with a fluid collection measuring approximately 33 x 15 mm in size in the axial plane as measured on image #32 of series #7.It has a superior to inferior extent of 20 mm as measured on coronal image #10 of series #8.This process in the paraspinous soft tissues was not present on the previous study: there is a rim of enhancement around this compatible with inflammation.On (b)(6) 2011: patient presented with right leg numb down to toes started thurs fluid pocket on spine, patient states pressure and sharp pain on r side and incontiness of bowel since thurs, tingling, numbness, back pain.On (b)(6) 2011: patient presented for med refills regarding pain, tingling, numbness, back pain, chronic pain syndrome, and neuropathy.On (b)(6) 2011: patient presented for follow up back pain, chronic pain syndrome, back pain, attention deficit disorder with hyperactivity.On (b)(6) 2011: patient presented for follow up back pain, tingling, numbness, back pain, right lower neuropathy.(b)(6) 2011: patient presented for follow up back pain.He states that he has begun physical therapy; pain has increased since then, chronic pain syndrome, back pain.On (b)(6) 2012: patient presented for med refills regarding pain, chronic pain syndrome stable, back pain.On (b)(6) 2012: patient presented with the history of chronic back pain and right lower extremity radiculopathy.Impression: acute on chronic low back pain with sciatica.On (b)(6) 2012: patient presented with back pain, chronic pain syndrome, radiculitis.On (b)(6) 2012: patient underwent x ray of the lower spine.On (b)(6) 2012: patient underwent therapeutic injection.As per the billing records, patient underwent x-ray.On (b)(6) 2013: patient presented with back/leg problems, paresthesia, experiencing numbness/tingling to bilateral lower extremities and had spinal cord stimulator placed x 3-4 months ago.Patient underwent ct scan of lumbar spine w/o contrast.Impression: no evidence for significant lumbar spine canal or foraminal stenosis or evidence for significant sizable disc herniation.L5-s1 fusion and l5 laminectomy, as detailed above, stable from prior exam.An acute finding within the lumbar spine by ct otherwise is not appreciated.The right flank spinal stimulator device is only partially imaged on this study, as detailed above.On (b)(6) 2015: patient presented with pain in his neck, back, wrist, knee and collar bone.Patient underwent ct scan and x-rays which reveals pain the hip left ear, high left shoulder, high right hip, cervical: misalignment, loss of lordosis, decrease disc space, thoracic: misalignment, lateral curvature, lumbar: misalignment, lateral curvature, fusion of l5/s1 with surgical appliance.On an unspecified date around (b)(6) 2010, patient underwent two lumbar discectomy surgeries and a lumbar spine fusion.(b)(6) 2010: patient presented with bulging disk on lower back.Mri l spine shows right l5-s1 herniated nucleus pulposis far lateral.On (b)(6) 2010:.Patient underwent lumbar esi.Patient tolerated the procedure well without any immediate complications.08/18/2010: patient presented for follow up.Patient presented with right hip and leg pain.Patient underwent mri l-spine which shows far lateral herniated nucleus pulposis right l.5-s1 herniated nucleus pulposus.On (b)(6) 2010: as per the billing records, patient underwent low back disk surgery.Patient underwent minimally invasive right l5-s1 disectomy.Procedure: minimally invasive right l5-s1 transforaminal lumbar discectomy, medial facetectomy, and partial hemilaminectomy using the microscope far microdissection and intraoperative banal fluoroscopy.On (b)(6)2010: patient underwent mri of the lumbar.Impression: multilevel degenerative disc disease most significant at l4-5 with post surgical changes of hemilaminectomy.Continued mass effect is seen on the right exiting nerve root here from a paracentral disc protrusion.On (b)(6) 2010: patient presented for follow up.Patient underwent mri l-spine.Assessment: recurrent herniated nucleus pulposus right l5-s1.On (b)(6) 2010: as per the billing records, patient underwent low back disk surgery.Patient presented with recurrent right l5-s1 herniated nucleus pulposus.Procedure: repeat right l5-s1 partial hermilaminectomy, medical facetectomy and discemomy using the microscope for microdiasection and the metrx retractor system for a minimally invasive approach.10/05/2010: patient presented for follow up.Patient presented with right sided pain and numbness, severe right hip and leg pain.On (b)(6) 2010: as per the billing records, patient underwent lumbar spine fusion and used spinal bone graft.There was removal of spinal lamina.Patient was presented with recurrent lumbar herniated disk.Intractable hack pain.Procedure: right transformational lumbar interbody fusion.L5-s1.Decompression.Right l5-s1 complete facetectomy, completion hemilaminectomty, and diskectomy to decompress the right s1 nervere.Rig ht l5-s1 diskectomy to prepare the disk space for arthrodesis using the microscope for microdissection and intraroperative lateral fluoroscopy.Arthrodesis.L4-5 posterior intervertebral arthrodesis.L5-s1.Using infuse-soaked collagen sponge and locally harvested autograft.Harvest of local autograft during the decompression.Instrumentation l5-s1 minimally invasive pedicle screw placement using the sextant system, placing a 6.5 mm pedicle screw at l5 on the left and right using 6.5 x 45-mm screw and at s1 a 6.5 x 40mm screw and dual 35-mm interlocking rods.Interbody device placement, l5-s1, using a peek capstone interbody device 10 x 26 mm packed with locally harvested autograft and rhbmp-2 soaked collagen sponge.Intraoperative neurologic monitoring.Free run emg and pedicle testing of the tap and the pedicle access probe.Inter op notes: small disk herniation was identified and significant degenerative disk disease.Op notes: a 10 x 25mm device filled with autograft was tamped into place.Around it had been positioned rhbmp-2-soaked collagen sponge.The pedicle screws were placed with the sextant system with testing at the pedicle access needle and the tap.The rods were connected.The locking screws were engaged and tightened down.No complications were reported.On (b)(6) 2010: patient underwent esophagogastroduodenoscopy with biopsy x1.Impression: normal upper endoscopy.On (b)96)2010: patient presented for follow up.Patient presented with pain.Patient underwent x-ray of the ap lateral views which reveals stable appearance of the l5-s1.Pedicle screws and connecting rods were noted at l5-s1.On (b)(6) 2010: patient presented with low back pain, right leg numbness.On (b)(6) 2010: patient presented for follow up.Assessment: worsening pain with some exacerbation.Patient underwent x-ray of anterior posterior lumbar which reveals presence of interbody device and instrumentation.On (b)(6) 2011: patient underwent mri of the lumbar spine.Impression: there is defect within the right posterolateral aspect of the inferior l5 vertebral body which may contain fluid.It represents a surgical defect with postoperative hematoma or seroma accounting for the presence of fluid.Posterior fusion with intervertebral body spacer l5-s1, the hardware components are otherwise grossly unremarkable.Normal alignment for the operative level.Geographic lucent defect identified in the posterior earlier of the l5 vertebral body predominantly right of midline with adjacent absence posterior cortex.Presumably these represent surgical defects in the absence of any clinical signs/symptoms of infection.On (b)(6) 2011: patient presented with tingling into his right leg.Patient underwent mri of the lumbar spine which shows good position of his instrumentation and a solid bony union.On (b)(6) 2011: patient presented with complain of right leg pain.
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