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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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Back to Search Results |
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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Hernia (2240); Numbness (2415)
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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 procedure for posterior lumbar interbody fusion and posterolateral fusion at l2-l5 with implant of peek cage and rhbmp-2.The rhbmp-2 was placed anteriorly in the disc space prior to insertion of the cage, as well as in the posterolateral gutters spanning the transverse processes.Following his surgery, the patient initially improved, but subsequently developed additional, new and/or worse pain, suffering, symptoms and disability.Specifically, the patient has experienced progressive, disabling pain in his lower back, radiating to his legs.As a result, he has difficulty sitting and walking.
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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.
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Event Description
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Per medical records: it was reported on (b)(6) 2010 patient complained of diffuse back pain, neck, mid back and lower back pain.Patient also complained of sleeping problems and his blood pressure was also up.Mri of cervical showed some mild arthritic changes.Mri of thoracic again showed some mild arthritic changes.Mri of lumbar showed disk degeneration and arthritic changes.Impression: patient has diffuse mechanical back pain centered primarily in the mid and lower.He has no findings of radiculopathy or myelopathy.Imaging studies showed some spondylosis with some disk degeneration and arthritic changes.
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Manufacturer Narrative
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(b)(4).
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Event Description
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On (b)(6) 2001: the patient presented with following preoperative diagnosis: right inguinal hernia.The patient underwent the following procedure: right direct inguinal hernia repair with plug and patch technique.No known patient complications were reported.On (b)(6) 2008: the patient presented with low back pain with radiculopathy.The patient underwent x-ray of lumbar spine.Impression: no evidence of an acute fracture or dislocation was seen in the lumbar spine; degenerative disc disease was present at l3-l4 level with disc space narrowing and endplate sclerosis.Otherwise unremarkable examination.On (b)(6) 2009: the patient presented with chest pain, unspecified.On (b)(6) 2012: the patient presented with inguinal pain.The patient complained of difficulty in urinating.It was reported that the hernia had come through the mesh in his abdomen.On (b)(6) 2012: the patient underwent ct scan of abdomen and pelvis.Impression: no acute findings identified on exam.The patient was discharged with the following diagnoses: abdominal pain, otherspecified site; unspecified essential hypertension; other and unspecified hyperlipidemia (b)(6) 2009 the patient presented with chest pain, suspected cardiac and underwent x-rays of the chest.On (b)(6) 2009 the patient presented with chest pain, shortness of breath and underwent x-rays of the chest.On (b)(6) 2010 the patient underwent ct of the thoracic spine dueto pain.Impression: normal alignment; minimal wedging of t7, t8, and t11 age indeterminate; no retropulsed fragments apparent; degenerative changes are noted.Ct of the cervical spine was normal.Ct of the brain/head was normal and it showed paranasal sinus disease.On (b)(6) 2012: the patient presented with right lower quadrant abdominal pain and complained of difficulty urinating.Per hospital, the hernia had come through the mesh in his abdomen.On (b)(6) 2010 the patient underwent ct of cervical spine with multiplanar reformats due to prior injury with pain.Impression: no acute finding.On (b)(6) 2012: the patient presented with low back pain.On (b)(6) 2012: the patient presented with low back pain with radiation into his bilateral buttocks intermittently down his bilateral lower extremities.The pain is currently a 7 of 10.
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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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It was reported that on (b)(6) 2007 the patient was admitted due to ankle pain s/p injury.The patient also underwent x-ray of the right ankle.Impression: small posterior calcaneal spur.(b)(6) 2008 the patient underwent mri of the lumbar spine due to low back pain and right leg pain.Impression: multiple chronic schmorl's node deformities and non compressive lumbar degenerative disc disease.(b)(6) 2008 the patient presented with the chief complaint of back pain.He also had an exacerbation of axial low back pain and right leg pain suggestive of an l4 radiculopathy.His axial back pain was worse than his leg pain.Mri revealed multiple lumbar degenerative disk disease, l2-3, l3-4, and l4-5, facet arthropathy of l4-5 that explains his l4 radiculopathy.On examination the lumbar spine was diminished with flexion and extension secondary to discomfort.Diagnoses: 1.Multilevel lumbar degenerative disk disease.2.Axial back pain.3.Right l4 radiculopathy.(b)(6) 2009 the patient underwent myoview imaging for stress test due to hypertension.Impression: normal stress cardiolite study.2.Ejection fraction 66%.(b)(6) 2010 the patient fell down while tackling an inmate.Diagnoses: disc degenerative disease l5/thoracic spine.(b)(6) 2010 the patient underwent ct of the lumbar spine due to prior injury with pain.Impression: 1.Multiple schmorl's nodes at l3, l4, and l5 which may be due to scheuerimann's disease.2.No acute finding.(b)(6) 2010 the patient presented with the history of back and neck pain.The patient underwent mri of the cervical spine due to neck pain.Impression: minimal uncovertebral hypertrophy, c5-6.Otherwise negative mri of the cervical spine.The patient also underwent mri of the lumbar spine due to back pain.Impression: degenerative disc disease with multiple schmorl's nodes showing endplate changes and contrast enhancement consistent with scheuermann disease.(b)(6) 2010 the patient presented with the history of back and neck pain.The patient underwent mri of the thoracic spine due to back pain.Impression: abnormal mri of the thoracic spine with multilevel degenerative disk disease.No acute compressive changes evident.Tiny right paracentral disk protrusion t7-t8.(b)(6) 2010 the patient presented with the history of low back pain.Also he reported inter scapular region pain in mid thoracic region.Also he reported numbness/tingling in buttocks and feet.On examination, there was pain with extension.Mri of the lumbar showed degenerative disease, facet arthropathy, l2-3, l3-4, l4-5, but no significant central stenosis at those levels.Mri of the thoracic spine demonstrated mild degenerative changes of the lower thoracic region.Again, mri of the cervical spine revealed no significant central stenosis; may be early facet arthroplasty.(b)(6) 2010 the patient presented with the history of low back pain and mid back pain with numbness & tingling in bilateral legs.(b)(6) 2010 the patient presented with severe axial back pain.He also had symptoms of some pain and numbness that radiates to the bottom of his feet.(b)(6) 2010 the patient presented with intractable back pain.He also reported pain and numbness radiating to the bottom of his feet.He also reported pain in low back, tail bone and both feet.Lumbar spine is significantly diminished in flexion and extension secondary to discomfort.Mri of the lumbar spine revealed significant degenerative disease at l2-3, 3-4, 4-5, with no significant central stenosis.(b)(6) 2010 the patient presented with pain in low back, tail bone and both feet.(b)(6) 2010 the patient presented with low back pain and bilateral leg pain.(b)(6) 2010 the patient presented with lumbar disc degenerative disease and underwent x-ray of the chest.Impression: normal chest.X-rays of the lumbar spine showed mild degenerative disk disease.(b)(6) 2010 the patient presented with the following diagnoses: 1.Multilevel lumbar degenerative disk disease.2.Intractable back pain.Mri revealed multilevel lumbar degenerative disk disease, l2-3, l3-4, l4-5.(b)(6) 2010 the patient presented with the pre-op diagnosis of lumbar degenerative disk disease with intractable severe back pain with radiculopathy.The patient underwent the following procedures: 1.Bilateral inferior laminotomy of l2, superior laminotomy l3, medial facetectomy, foraminotomy for decompression of bilateral l2 and l3 nerve roots.2.Bilateral inferior laminotomy l3, superior laminotomy l4, bilateral medial facetectomy, foraminotomy for bilateral decompression of l3 and l4 nerve roots.3.Bilateral inferior laminotomy l4, superior laminotomy l5, medial facetectomy, foraminotomy for bilateral decompression of l4 and l5 nerve roots.Interbody arthrodesis with insertion of peek cage with local morselized bone graft and infuse at l3-4.4.Bilateral inferior laminotomy l4, superior laminotomy l5, medial facetectomy, foraminotomy for bilateral decompression of l4 and l5 nerve roots.Interbody arthrodesis with insertion of peek cage with local morselized bone graft and infuse at l4-5.5.Posterior lateral fusion using infuse, mastergraft compression resistant matrix, morselized bone graft augmented with cancellous chips, bilateral l2-5.6.Segmental instrumentation using pedicle screws bilaterally at l2, l3, l4, and l5.Per-op notes, all disk and cartilaginous endplates were removed from the endplates of l4 and l5.Once this was completed, morselized local bone graft was mixed with infuse and inserted anterior in the disk space.A peek cage was filled with infuse and local morselized bone graft and inserted into the intervertebral space.This was again anterior.The remainder of the disk space was filled with local morselized bone graft.Then at l3-4 level, the endplates were dec orticated and arthrodesis using local morselized bone graft, infuse followed by the peek cage filled with bmp and morselized local bone graft was performed.Again the interspace was packed with morselized local bone graft after the peek cage was inserted.At l2-3 level, posterolateral arthrodesis was completed with a combination of infuse, compression resistant mastergraft, morselized bone graft and cancellous chips.X-rays of the lumbar spine showed interval placement of intervertebral disk spacers at the l3-l4 and l4-l5 levels.Pedicle screws remain in place and unchanged.The alignment of the visualized vertebral bodies is anatomic.No patient complications were reported.(b)(6) 2010 the patient was discharged home.Final diagnosis: multilevel lumbar degenerative disk disease with radiculopathy.(b)(6) 2010 the patient presented for a post-op follow up visit with significant lumbar paraspinal muscle spasms.His leg pain has resolved.On an unknown date of 2011, the patient presented for a follow up visit with significant axial back pain, especially when bending forward and sitting and still has decreased range of motion in his lumbar spine, especially with flexion.His lower extremity symptoms have resolved.Ct scan of his lumbar spine revealed solid arthrodesis at l2 through l5.His interbody graft at l4-5 and l3-4 and a solid posterior lateral arthrodesis at all 3 levels.(b)(6) 2011 the patient presented for a post op follow up visit with significant axial back pain radiating through the region of his left hip.The patient underwent x-ray of lumbosacral spine due to low back pain.Impression: posterior lumbar fusion at l2 through l5 with no evidence of hardware complication.The alignment is anatomic.(b)(6) 2011 the patient presented for a post op follow up visit complained of pain in buttocks.The patient still continued to have s ensitivity and numbness around the region of his incision and low back pain that radiates to his hips.Radiographs of his lumbar spine revealed good position of hardware and graft.(b)(6) 2011 the patient presented for a follow up visit with significant axial back pain especially when sitting.Lumbar spine is still diminished secondary to discomfort.(b)(6) 2011 the patient presented for a follow up on his low back pain.The patient underwent ct of the lumbosacral spine due to lumbar disc degenerative disease.Impression: the patient is status post previous fusion procedure in anatomic alignment.(b)(6) 2014 the patient presented with the history of pain and underwent ct of the lumbar spine.Impression: 1.Fusion of the lumbar spine.2.No fracture, subluxation, residual or recurrent disc pathology by this test.(b)(6) 2010: patient presented with severe back pain in thoracic and lumbar region.Neuro system review revealed weakness and numbness.Impression: severe thoracolumbar back pain (b)(6) 2010: the patient presented for follow-up with pain and numbness that radiated to the bottom of his feet.Review of mri of lumbar spine showed significant degenerative disease at l2-3, l3-4, and l4-5 with no significant stenosis.(b)(6) 2010 primary procedure: l3-l4, l4-l5 transforamenal lumbar interbody fusion with cell saver and l2-l3 posterior lateral decompression /c fusion.(b)(6) 2011 patient underwent ct scan of lumbar spine without contrast due to lumbar disc degenerative disease.
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Manufacturer Narrative
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Review of radiographic images found as follows: (b)(6) 2009 chest x ray (b)(6) 2009 chest x ray no comments (b)(6) 2010 cervical spine ct grossly normal (b)(6) 2010 ct head grossly normal (b)(6) 2010 ct t spine grossly normal (b)(6) 2010 ct lumbar spine straightening of lumbar lordosis.No ectopic bone present.Preop ct, report shows multiple superior endplate deformities with schmorl¿s deformity l3, l4, l5, raising possibility of scheuermann¿s disease.(b)(6) 2010 mri cervical spine grossly normal (b)(6) 2010 mri lumbar spine +/- contrast degenerative disc disease l2-3, l3-4, l4-5 with superior endplate deformities at each of these levels secondary to schmorl¿s nodes.Overall canal diameter and neural foramen appear patent at each of these levels.(b)(6) 2010 mri t spine grossly normal summary: pre-op imaging only is provided on this disc.This shows multilevel intervertebral disc herniations at l3, l4, l5 as the supposed imaging rationale for l3-l5 plf procedure described.By report each level was decorticated and an interbody device and infuse was placed.Off-label use with placement in the postero-lateral space was also described.No post-operative imaging is provided.Would need to see post-operative ct and mri to determine presence of heterotopic bone formation, adjacent level degeneration, hardware placement or other structural causes to explain post op back pain, radicular pain and disability.(b)(6) 2007 right ankle x-rays ap, lateral and mortis views of the right ankle appear normal.No fracture, soft tissue swelling, arthritis or subluxation is apparent.Hindfoot appears normal.Mortise seems to show some lytic changes within the distal fibula but this is not specific.(b)(6) 2010 chest x-rays pa and lateral views are provided.These show normal lung fields.Bony anatomy appears normal.Cardiac shadow appears normal.Some hilar prominence is noted on the right.No effusions or infiltrates.Stomach bubble is in normal position.Lateral view shows normal thoracic kyphosis without fracture or disc space narrowing.Lumbar x-rays multiple views are provided.Small floating rib is seen off of l1 bilaterally.Si joints, hips and pubis appear normal.Sagittal lordosis is maintained.No significant disc space narrowing is noted on spot or lateral views.(b)(6) 2010 lumbar x-rays probe is seen centered at l4 on lateral view.Second lateral shows interval placement of pedicle screws with rods bilaterally, spanning l2, l3, l4 and l5.No rods or spacers have yet been inserted.Final view on this date shows interbody crescent spacers no in place at l4 and l3.(b)(6) 2011 lumbar series multiple views are provided showing final construct from l2 to l5 with pedicle screws, rods and crosslink spanning from l2 to l5.Interbody spacers are now seen at l3 and l4.Oblique views show good position of construct components.Lumbar lordosis is well maintained.(b)(6) 2011 lumbar ct sagittal, coronal and axial views are reviewed.Complex construct from l2 to l5 is noted with bilateral segmental pedicle screws.Interbody spacers are noted at l4 and l3 but none at l2.Axial views show good position of pedicle screws and spacers.Hemi laminectomy has been performed on the left at l4/5.No stenosis is documented either within the central canal or along the foramina.Scout view now shows screws as noted above with rods and crosslink (between l3 and l4).Overall lumbar alignment is satisfactory on these films.Heterotopic bone is appreciated at l4/5 on the left in the track for insertion of the l4 spacer.(b)(6) 2014 lumbar ct sagittal, coronal and axial views are reviewed.Complex construct from l2 to l5 is noted with bilateral segmental pedicle screws.Interbody spacers are noted at l4 and l3 but none at l2.Axial views show good position of pedicle screws and spacers.Hemilaminectomy has been performed on the left at l4/5.No stenosis is documented either within the central canal or along the foramina.Scout view now shows screws as noted above with rods and crosslink (between l3 and l4).Overall lumbar alignment is satisfactory on these films.Heterotopic bone is again appreciated at l4/5 on the left in the track for insertion of the l4 spacer.(b)(6) 2008 lumbar x-rays three views of the lumbar spine.Ao shows normal alignment with 5 lumbar vertebra.Sacroiliac and hip joints appear normal.Lateral view also appears normal with no disc space collapse, sclerosis or osteophytes.Lordosis is maintained.L5 spot is normal.Pelvic x-rays ap and frog leg lateral views show normal hip joints an sacroiliac joints.Ilium, ischium, pubic and proximal femora are normal in appearance.(b)(6) 2008 lumbar mri t2 sagittal views show desiccation with narrowing of l2, l3 and l4.Schmorl¿s notes are seen in the anterior superior endplates of l3, l4 and l5.Conus is at l1.No stenosis is noted.Axial views verify the above findings.No specific stenosis or hnp is found.Hiz (hyperintense zones) are noted in the posterior annulus of the degenerative levels.Posterior elements, facets appear to show mild arthritic hypertrophy at the arthritic levels.(b)(6) 2012 abdominal ct scout view shows interval posterior fusion with interbody peek spacers and bilateral pedicle screws with rods involving l2, l3, l4 and l5.Abundant artifact obscures the anatomy of the spinal canal and posterior elements from l2 to l5.
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Event Description
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(b)(6) 2009 the patient presented to the emergency room with the complaint of sub sternal chest pain radiating to the left chest off and on.He described the chest pain as pressure lasting 10 to 15 minutes at a time associated with diaphoresis, shortness of breath and feeling like his heart was fluttering.He also developed sinus tachycardia in the emergency room.(b)(6) 2009 the patient was discharged home with the following final diagnoses: chest pain; sinus tachycardia; hypercholesterolemia, primary hypertension.(b)(6) 2009 patient presented for follow-up and his blood pressure was up.Assessment: hypercholesterolemia, primary hypertension, asthma.(b)(6) 2010: patient complained of neck pain, left hand weakness, thoracic back pain, low back pain radiating to bilateral hips.Patient had left hand injury and weak left fist and he had recent work injury and neck pain, back pain and bilateral sciatic pain.Neck: tender cervical vertebral tapping, with limited range of motion in all directions.Thoracic spine: tender thoracic vertebral tapping with limited all range of motion in all direction.Lumbar-sacral spine: tender lumbar vertebral tapping with limited all range of motion in all directions.Assessment: acute neck pain, acute back pain, hand contusion, sprain and/or strain of thoracic spine, strain cervical, contusion neck, strain lumbar acute, bilateral lumbar radiculopathy (b)(6) 2010 patient had multiple risk factors for osteoporosis and presented for a bone mineral density scan.Assessment: osteoporosis (thinning weakness or brittle bones).The patient was also assessed with premature atrial or supraventricular contractions, and premature ventricular contractions.The patient was presented with persistent neck pain, radiating through thoracic spine to his bilateral hip, also complained of his left hand weakness about the same.Patient also had cat scan of the c-spine that showed mild narrowing of the right c3-c4 foramen, patient's thoracic spine cat scan showed minimal wedging of the t7, t8 and t11, with degenerative changes.Patient's lumbar-sacral spine cat scan also reviewed and showed bulging disc l4-l5, l5-s1, mild degenerative disc disease at l3-l4, and multiple schmorl's nodes.Patient also complained of wheezing off/on times one day last week and his heart races with skipped heart beat some times.Patient also complained of facial sinus congestion, post-nasal drip, sneezing and sinus headache.Patient had left hand injury and weak left fist and had recent work injury and neck pain, back pain and bilateral sciatic pain.Neck: tender cervical vertebral tapping, with limited range of motion in all directions because of pain and stiffness.Thoracic spice: tender thoracic vertebral tapping with limited all range of motion in all direction due to pain.Lumbar-sacral spine: tender lumbar vertebral tapping with limited all range of motion in all directions because of pain and stiffness.Assessment: acute neck pain, acute back pain, hand contusion, sprain and/or strain of thoracic spine, strain cervical, contusion neck, strain lumbar acute, bilateral lumbar radiculopathy, sinusitis acute, asthma, hypercholesterolemia, cardiac dysrhythmia, osteopenia.(b)(6) 2010 patient complained about hurting bad in the neck, center of his back and lower back.Patient's blood pressure was up.Patient had history of hypertension as he was treated with antihypertensive agents in the past few months.Patient had left hand injury and weak left fist.Patient had recent work injury and neck pain, back pain and bilateral sciatic pain.Neck: tender cervical vertebral tapping, with limited range of motion in all directions due to pain and stiffness.Thoracic spine: tender thoracic vertebral tapping with limited all range of motion in all directions.Lumbar-sacral spine: tender lumbar vertebral tapping with limited all range of motion in all raising test.Assessment: primary hypertension, hypercholesterolemia, arrhythmia syndrome, left hand contusion, contusion neck, sprain and/or strain of thoracic spine, strain lumbar acute, bilateral lumbar radiculopathy, neck pain, back pain.(b)(6) 2010 patient presented with the complaints of persistent neck pain, mid thoracic back pain and low back pain radiating to bilateral hips.Patient continued to complain of left hand weakness, neck contusion, associated with thoracic spine sprain and lumbar-sacral spine strain caused by work injury because of heavy unbalanced lifting.Patient's thoracic spine mri was reviewed, and showed mild paracentral disk protrusion t7-t8, with multilevel degenerative disc disease.Patient's lumbar spine mri is also reviewed and showed l4-l5 bulging disc with mild facet hypertrophy, degenerative disc disease with multiple schmorl's nodes.Patient's cervical spine mri is also reviewed and showed minimal bilateral foraminal narrowing from unconvertible hypertrophy c5-c6.Patient blood pressure was up.Patient had left hand injury and weak left fist.Patient had recent work injury and neck pain, back pain and bilateral sciatic pain.Neck: tender cervical vertebral tapping, with limited range of motion in all directions about the same because of pain and stiffness.Thoracic spine tender thoracic vertebral tapping with limited all range of motion in all range of motion in all directions.Lumbar-sacral spine: tender lumbar vertebral tapping with limited all range of motion in all directions because of pain and stiffness.Assessment : contusion neck, sprain and/or strain of thoracic spine, strain lumbar acute, bilateral lumbar radiculopathy, left hand weakness arrhythmia syndrome, hypercholesterolemia, primary hypertension (b)(6) 2010 the patient presented for follow-up with back pain worse between shoulder blades, bilateral leg numbing and tingling since started physical therapy.Patient's lumbar-sacral spine mri was reviewed and showed multilevel degenerative disc disease with findings consistent with scheuermann disease.Patient had left hand injury and weak left fist.Patient had recent work injury and neck pain, back pain and bilateral sciatic pain.Neck: patient had limited range of motion in all direction due to pain and stiffness.Thoracic spine: tender thoracic vertebral taping with all range of motion in all directions.Lumbar-sacral spine: tender lumbar vertebral tapping with limited all range of motion in all directions due to pain and stiffness.Assessment : left hand contusion, contusion neck, sprain and/or strain of thoracic spine, strain lumbar acute, bilateral lumbar radiculopathy, neck pain, back pain, primary hypertension, hypercholesterolemia, insomnia, arrhythmia syndrome.Update (b)(6) 2015 notified (b)(6) 2015 medications: lexapro (b)(6) 2006: patient presented with injured right knee.(b)(6) 2006: patient injured his finger while digging a drain.(b)(6) 2006: patient presented with injured right index finger and pain.Patient was unable to bend finger.(b)(6) 2007: patient underwent x-ray after a knee accident at work.(b)(6) 2007: patient presented with right knee pain which got hurt at work.Per patient, there was grinding sensation on one side of knee and hurt on bottom of knee.Per patient, pain was constant.(b)(6) 2007: patient presented with cough and headache.Per patient, cough was coming from deep in chest and there was green discharge from nose.(b)(6) 2008: patient presented with sore throat and cough.(b)(6) 2008: patient presented to discuss results of mri.(b)(6) 2008: patient presented for follow up on back pain.(b)(6) 2008: patient resented with back pain for discussion on medication.Assessment: (b)(6) 2011: patient presented for follow up.Assessment: depression.(b)(6) 2009: patient diagnosed with fatigue, heartburn, and hyperlipidemia.(b)(6) 2009: patient underwent 2-d echocardiogram, m-mode echocardiogram, and doppler echocardiogram.Impression: echocardiography was performed with 2-d imaging, color doppler flow analysis, and spectral doppler waveform analysis; good left ventricular systolic function, ejection fraction is 50%; normal chamber dimensions and wall thickness; no ventricular chamber clot identified; normal-appearing mitral, tricuspid, and aortic valve leaflets; trace mitral and tricuspid valve regurgitation by color doppler flow analysis and spectral doppler waveform analysis; no pericardial effu.
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Manufacturer Narrative
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(b)(4).(persisting back pain).
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Event Description
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It was reported that on, (b)(6) 2008: patient presented with the chief complaint of low back pain and also reported having cough, fever, sore throat.On (b)(6) 2010: patient underwent ¿ncv¿ studies on left upper extremity.Interpretation: these findings are consistent with normal left arm examination.On (b)(6) 2010: patient underwent ¿ncv¿ studies on left upper extremity.Interpretation: these findings are consistent with normal left arm examination.On (b)(6) 2010: patient visited for physical session and received electrical simulation and vaso, manipulation, and 30 minutes of therapeutic exercise.On (b)(6) 2011: patient presented for an office visit with chief complaint of back injury and depression.On (b)(6) 2011: patient presented for an office visit with chief complaint of back pain; patient also got the medications refilled.On (b)(6) 2012: the patient presented with back pain.Muskuloskeletal examination revealed tenderness in back and restricted range of motion.Assessment: failed back syndrome.On (b)(6) 2014 patient presented for a follow-up visit.On (b)(6) 2014, (b)(6) 2015 patient presented for an office visit due to history of failed back and chronic back pain.On (b)(6) 2015 patient presented due to f/u on pain.On (b)(6) 2015 patient presented for ¿f/u on meds¿.On (b)(6) 2015 patient presented due to back pain.04 jan 2016 patient presented due to chest congestion.On (b)(6) 2016 patient presented for an office visit due to back pain and muscle spasms.
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Event Description
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It was reported that on (b)(6) 2010 the patient presented for neurosurgery follow-up with significant back pain radiating down hips.
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