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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 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Contusion (1787); Cyst(s) (1800); Edema (1820); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Seroma (2069); Vomiting (2144); Weakness (2145); Hernia (2240); Stenosis (2263); Discomfort (2330); Neck Pain (2433); Shaking/Tremors (2515); Sleep Dysfunction (2517)
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Event Type
Injury
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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 on (b)(6) 2007: the patient underwent diskectomy and fusion, procedure: left anterior lumbar spine exposure of l2-l3 and l3-l4 disk space level, resection of 11th rib, pre-op diagnosis and post-op diagnosis: degenerative disk disease l2-l3, l3-l4 disk space level.Per-op: l2-3 and l3-4 disk spaces were exposed with cobb retractor.Then surgeon performed discectomy and fusion.The patient also underwent x-ray of lumbar spine due to radiculopathy.On (b)(6) 2007: the patient underwent ct scan of the abdomen and pelvis with oral and intravenous contrast due to chief complaint of pain, conclusion: difficult to distinguish between postoperative edema and potential postoperative complications, x-ray of two views lumbar spine due to pain, conclusion: postoperative changes in the lumbar spine.On (b)(6) 2007: he had some left lower extremity muscle spasms.On (b)(6) 2007: the patient underwent three view x-ray of lumbar spine post fusion, impression: stable posterior interbody fusion from l2 through s1.On (b)(6) 2007: the patient presented for follow up and underwent dxl spine.He was still having some abdominal and lumbar spinal muscular discomforts that are worse at night.On (b)(6) 2007: the patient underwent x-ray due to post fusion low back pain, impression: slightly more intervertebral disk space narrowing at l5-s1 than prior study, posterior lumbar spine fusion otherwise stable.On (b)(6) 2007: the patient presented for follow up.Impressions: posterior lumbar spine fusion otherwise stable.On (b)(6) 2007: the patient underwent x-ray of lumbar spine due to low back pain, impression: stable x-rays lumbar spine.The patient underwent x-ray.Impressions: bilateral bone fusion material appear intact as laminectomy changes.On (b)(6) 2007: the patient presented for magnetic resonance imaging of the right shoulder without contrast, impression: abnormal subtle small linear increased signal along the undersurfaces of the distal supraspinatus tendon, seen only on oblique coronal sequences.A focal partial undersurface tear of the distal supraspinatus tendon cannot be excluded.Supraspinatus tendinosis visualized elsewhere, small amount of focal bone marrow edema within the humeral head, suggesting contusion without underlying fracture, mild subacromial-subdeltoid bursitis, 4.3mm anterior-inferior paralabral cyst and mild irregularity throughout the anterior labrum without definite focal tear.Consider further evaluation with mr arthrography of the right shoulder for further evaluation if there is a concern for a labral tear based on clinical presentation.The patient further presented for magnetic resonance imaging of the cervical spine without contrast.Impression: mild degenerative disk disease of the mid-to-lower cervical spine with small-to-moderate diffuse disk bulges at c4-5 and c5-6 without focal herniation, no significant neural foraminal or central canal narrowing.On (b)(6) 2007: the patient underwent lumbar spine, three view examination due to low back pain post fusion.The patient presented for follow up.The patient underwent three side view x-ray there were some disk degenerative changes.On (b)(6) 2008: the patient was presented for follow up.Impressions stable appearance of lumbar spine.On (b)(6) 2008: the patient underwent lumbar spine examination, impression: postoperative changes lumbar spine to include a posterior fusion and interbody fusion changes, normal alignment, hardware is intact.The patient underwent x ray of lumbar spine.Impressions : hardware is intact.On (b)(6) 2009: the patient underwent lumbosacral spine examination, impression: stable posterior fusion and diskectomies from l2 down to s1.No change in the appearance of the spine nor of the hardware in comparison to previous studies, previous trauma notes to the anterior inferior aspect of t11 vertebral body which was stable.The patient underwent x ray of lumbosacral spine.On (b)(6) 2010: the patient presented for mri(magnetic resonance imaging) of the lumbar spine with and without iv gadolinium contrast agent, impression: severe neural foraminal narrowing on the right at l4-5 and l5-s1.There is also moderate left and moderate to severe left neural foraminal narrowing on the left at l4-5 and l5-s1 respectively, stable appearance of post surgical seroma in the posterior paraspinous soft tissues, stable post surgical changes, overall there is no significant change as compared to the prior study from (b)(6) 2009.On (b)(6) 2010: the patient was presented for follow up, mri of left spine was performed with and without iv gadolinium contrast agent.On (b)(6) 2010: the patient underwent lumbar spine eight views due to low back pain and lumbar fusion, impression: re-demonstrated extensive laminectomy and posterior fusion spanning l2-s1 with pedicle screws and paired tension rods, intervertebral spacing devices in stable alignment.Mature posterolateral bone graft re-demonstrated.No hardware complications or acute fracture is identified, patient fusion of the l3-4, 4-5, and interspaces.There is mild persistent degenerative disk space narrowing at l2-3.Disk space at l1-2 is preserved, re-demonstrated moderate degenerative disk changes of lower thoracic spine t11-12 and t10-11, probable significant neural foraminal encroachment at l4-5 and l5-s1 in part related to hypertrophic facet osteoarthropathy and partly related to bone graft potentially, with flexion and extension, relatively little movement is noted.There are no worrisome subluxations.The patient presented for radiology at pelvis due to left low back pain and leg pain, impression: no acute fracture or misalignment.Mild degenerative irregularity of the sacroiliac joints.Mineralization with normal limits, post surgical changes of the lower lumbar spine, portions of the sacrum are obscured by bowel gas.The patient underwent triple phase bone scan of the lumbar spine and suspect of the lumbar spine, impression: mild to moderate tracer uptake at the posterior processes of l2 and at the disk spaces of l3-l4 and l5-s1, decreased uptake at the posterior elements of l2-s1, consistent with post surgical lumbosacral fusion changes with no complications, left total knee arthroplasty without complications.On (b)(6) 2010: the patient presented for follow up.Impressions: portions of the sacrum are obscured by bowel gas.Left total knee arthroplasty without complications.On (b)(6) 2010, (b)(6) 2011: the patient presented for office visit due to shoulder pain and posterior right-sided neck discomfort.On (b)(6) 2010: the patient presented for follow up.He has noticed 60% improvement in his low back pain with is recently performed left si joint injection.On (b)(6) 2011: the patient presented for follow up.Findings: rotator cuff: there is abnormal linear signal within the distal supraspinatus tendon near site of insertion in a linear fashion extending to the articular surface evident only on oblique coronal images.Osseous structures: there was number of fracture.Biceps tendon: the biceps tendon is intact and is normally situated in the bicipital groove.Glenohumeral joint: there is no glenohumeral joint effusion, however, there is a tiny amount of fluid in the subcoracoid recess.Miscellaneous: there is a very small amount of fluid within the subacromial-subdeltoid bursa indicating labrum.The cervical spine vertebral bodies are normal in height and alignment.Mild disc spaces narrowing is present at c4-5 and c5-6.There was no abnormal bone marrow signal.The disc remain well hibernated.Impressions : no significant neural foraminal or central canal narrowing (b)(6) 2011: the patient presented to the office with chief complaint of low back pain.Impression: status post extensive spinal fusion with paired pedicle screws and posterior spinal fusion rods extending from l2 through s1.Interbody spacing devices at the fused levels remain stable, there is mature osseous fusion of the l4-5 and l5-s1 interspaces.Mature posterolateral bone graft is present along the fused levels, no acute fracture or hardware complications identified, with flexion and extension, there is no significant motion of the fused segments, nor of the levels above the fusion.There is only mild degenerative disk disease at the l1-2 level above the level of fusion.The patient presented to the office with another complaint of neck pain, impression: ap, lateral, odontoid, bilateral oblique, and flexion-extension views of the cervical spine, no acute fracture or misalignment, preserved vertebral body height and alignment.Intervertebral disk spaces are relatively well-preserved, facet complexes remain well-aligned.Minimal degenerative facet irregularity, mild uncovertebral spurring resulting in mild right c3-4 neural foraminal narrowing.Remaining neural foramina remain widely patent, with flexion and extension, no vertebral subluxations to suggest spinal in stability.On (b)(6) 2011: the patient presented for follow up.Findings: no fracture was identified, bony alignment is normal, bony pelvis appears intact.Hip joints appear unremarkable.Impressions: normal acromioclavicular joint, no other significant osseous or soft tissue abnormality.Status post extensive spinal fusion with paired pedicles screws and posterior spinal fusion rods extending from l2 through s1.Interbody spacing devices at the fused levels remains stable.There was mature osseous fusion of the l5-s1 interspaces.Mature posterolateral bone graft is present along the fused levels.No acute fracture or hardware complication identified.With flexion and extension, there was no significant motion of the fused segments nor of the levels above the fusion.Ap, lateral, odontoid, bilateral oblique, and flexion-extension views of the cervical spinal.Preserved vertebral body height and alignment.Facet complexes remains well aligned.Mild uncovertebral spurring resulting in mild degenerative facet irregularity.On (b)(6) 2011: the patient presented for office visit due to shoulder pain and posterior right-sided neck discomfort.Assessment: review of the images of his recently performed cervical spine x-rays, lumbosacral spine x-rays, mri scan of his shoulder and mri scan of his cervical spine reveal disk bulging c4-5 and c5-6 and possible small right supraspinatus tendon tear.On (b)(6) 2013: the patient presented to the office with chief complaint of abdominal wall hernia.
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Manufacturer Narrative
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(b)(4) (persisting back pain).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) 2007: the patient underwent diskectomy and fusion, procedure: left anterior lumbar spine exposure of l2-l3 and l3-l4 disk space level, resection of 11th rib, pre-op diagnosis and post-op diagnosis: degenerative disk disease l2-l3, l3-l4 disk space level.Per-op: l2-3 and l3-4 disk spaces were exposed with cobb retractor.Significant amount of degenerative disk material was removed from both disk spaces.Disk spaces were then sized to fit interbody fusion cages.Both spaces were sized for a 12mm in height, 5 medium size cages at 5-degree angles.The left t11 autologous graft material was then harvested.A medium bmp was prepared and were made to fit in interbody fusion cages.Cages were inserted into interspaces at l2-3, l3-4.Remaining bone graft material was then packed anterior to cages.Then surgeon performed discectomy and fusion.The patient also underwent x-ray of lumbar spine due to radiculopathy.On (b)(6) 2007: patient presented for office visit.On (b)(6) 2007: the patient underwent: ct scan of the abdomen and pelvis with oral and intravenous contrast due to chief complaint of pain, conclusion: difficult to distinguish between postoperative edema and potential postoperative complications; x-ray of two views lumbar spine due to pain, conclusion: postoperative changes in the lumbar spine.Patient presented with intractable vomiting.Discharge diagnosis: reactive thrombocytosis, gastroenteritis, possible narcotic induced nausea and vomiting.On (b)(6) 2007: patient presented feeling agitated.Patient presented with following diagnosis: leg tremor.Discharge diagnosis: left leg tremor.Thrombocytosis.On (b)(6) 2007: patient presented for office visit.On (b)(6) 2007: patient presented with pain in left leg.Patient presented with following diagnosis: possible left hernia, chronic left leg pain.On (b)(6) 2007: the patient underwent three view x-ray of lumbar spine post fusion, impression: stable posterior interbody fusion from l2 through s1.On (b)(6) 2008: the patient was presented for follow up.Impressions stable appearance of lumbar spine.Patient underwent radiographic study of lumbar spine.Impression: stable appearance of the lumbar spine following extensive lumbar fusion.On (b)(6) 2008, patient underwent mri of left knee due to knee pain.Summary: pominent chondromalacia changes in the medial compartment; internal degeneration and a tiny non-displaced tear of the medial meniscus; moderate edema in the medial tibial plateau, most likely related to the chondromalacia and associated subchondral edema.A component of bone contusion is possible.The possibility of a small non-displaced occult fracture involving the anterior aspect is judged to be unlikely; borderline enlargement of the lateral meniscus; moderate sized joint effusion with a tiny baker¿s cyst; moderate strain of the anterior cruciate ligament.On (b)(6) 2008, patient underwent mri of right knee.Impression: complex tear body and posterior horn of the medial meniscus with slight medial extrusion of the meniscus and adjacent edema in the tibial plateau; some chondromalacia changes in the medial compartment; small moderate joint effusion with a small baker¿s cyst.On (b)(6) 2008, (b)(6) 2009: the patient presented with lower back and leg pain.On (b)(6) 2009: patient presented with severe chronic low back pain.Assessment: moderate to severe chronic low back pain with prior history of l5-s1 spinal fusion.The patient has component of what seems like s1 radiculopathy bilaterally.On (b)(6) 2009, patient underwent mri of lumbar spine, enhanced and unenhanced.Impression: full surgical fixation at l2 through s1 with surgical hardware.Dorsal laminectomy changes noted at l2 through l5.A moderate sized posterior seroma is seen dorsal to the dural sac not appreciabely affecting the sac.There is no evidence of any central canal stenosis, recurrent or residual disk herniation, malalignment of the lumbar vertebral bodies, or epidural fibrosis.Mild foraminal stenosis may be present on the right at l4-5.Mild disc space narrowing and mild disc bulging is noted at t11-12.On (b)(6) 2009: patient presented with complaint of low back pain.Assessment: chronic low back pain with history of l5-s1 spinal fusion.He reports pain reduction with taking muscle relaxant.On (b)(6) 2009: patient presented with complaint of low back pain.Assessment: chronic low back pain with discogenic component and with history of 1.5-s1 spinal fusion.Pain control had improved and now successfully off oxycontin.On (b)(6) 2009: patient underwent three view left knee radiograph.Impression: no fracture malalignment or joint effusion; mild degenerative changes; two suspected intra-articular loose bodies.On (b)(6) 2010: the patient underwent mri of the left knee without contrast.Impression: chronic osteoarthritic degenerative change medial compartment with joint space narrowing, articular cartilaginous thinning, osteophyte formation and subcortical edematous change most pronounced anterior peripheral medial tibial plateau.Medial meniscus is diminutive with amorphous meniscal degradation.No meniscal tear is defined; lesser degree of osteoarthritic degenerative change involving the patellofemoral compartment and lateral compartment, again without acute finding; progressive degenerative change to the proximal tibiofibular articulation with subcortical edematous change and apparent synovial cyst extending off of the posterior medial aspect of the joint; abnormal anterior cruciate ligament.Abnormality more defined than previous study suggesting interval injury.On (b)(6) 2010: the patient underwent portable radiographs of the left knee.On (b)(6) 2010: patient presented with complaint of severe left knee pain.Assessment: recent left total knee replacement with persistent pain, postsurgical; improved low back pain with history of l5-s1 spinal fusion.On (b)(6) 2010: the patient was presented for follow up, mri of left spine was performed with and without iv gadolinium contrast agent.Impression severe foraminal narrowing on the right at l4-5 an l5-s1.This has not significantly changed as compared to prior examination.There is also moderate left and moderate to severe left neural foraminal narrowing on the left at l4-5 and l5-s1 respectively, also not significantly changed as compared to the prior study; stable appearance of the post-surgical seroma in the posterior paraspinous soft tissue; stable post-surgical changes; overall there is no significant change as compared to the prior study from (b)(6) 2009.On (b)(6) 2010: patient presented with complaint of severe left leg pain.Assessment: recent left total knee replacement with improving postsurgical pain; however, he continues to have mildly to moderately limited range of motion in the left knee; chronic low-back pain with prior history of lumbar spinal fusion.Examination is somewhat equivocal for lumbar radiculopathy.He may have more pain due to hamstring tightness.On (b)(6) 2010: the patient was pre-operatively diagnosed with anxiety and symptomatic bilateral sacroiliac joint arthritis and underwent the following procedures: iv conscious sedation for a total of 30 minutes time, 6 mg of versed and 50 mg of fentanyl; bilateral sacroiliac joint injections with formal arthrogram; fluoroscopic imaging of patient lumbosacral spine during bilateral sacroiliac joint injections with formal arthrograms.On (b)(6) 2011: patient underwent mri of right shoulder without contrast.Impression: abnormal subtle small linear increased signal along the undersurface of the distal supraspinatus tendon, seen only on oblique coronal sequences.A focal partial undersurface tear of the distal supraspinatus tendon cannot be excluded.Supraspinatus tendon visualized elsewhere; small amount of focal bone marrow edema within the humeral head, suggesting contusion without underlying fracture; mild subacromial-subdeltoid bursitis; 3mm anterior-inferior paralabral cyst and mild irregularity throughout the anterior labrum without definite focal tear.Consider further evaluation with mr arthrography of the right shoulder for further evaluation if there is a concern for labrum tear based on clinical presentation.Patient underwent mri of cervical spine without contrast.Impression: mild degenerative disc disease of the mid to lower cervical spine with small to moderate diffuse disc bulges at c4-5 and c5-6 without focal herniation; no significant foraminal or central canal narrowing.On (b)(6) 2011:patient underwent x-ray of cervical spine with oblique views.Impression: ap, lateral, odontoid, bilateral oblique, and flexion-extension views of the cervical spine; no acute fracture or misalignment; preserved vertebral body height and alignment.Intervertebral disk spaces are relatively well-preserved; facet complexes remain well-aligned.Minimal degenerative facet irregularity; mild uncovertebral spurring resulting in mild right c3-4 neural foraminal narrowing.Remaining neural foramina remain widely patent; with flexion and extension, no vertebral subluxations to suggest spinal instability.Patient underwent x-ray of shoulder.Impression: no acute fracture or malalignment; glenohumeral joint space within normal limits; normal acromioclavicular joint; no other significant osseous or soft tissue abnormality.Patient underwent x-ray of lumbar spine.Impression: status post extensive spinal fusion with paired pedicle screws and posterior spinal fusion rods extending from l2 through s1.Interbody spacing devices at the fused levels remains stable; there was mature osseous fusion of the l5-s1 interspaces.Mature posterolateral bone graft is present along the fused levels; no acute fracture or hardware complication identified; with flexion and extension, there was no significant motion of the fused segments nor of the levels above the fusion.Patient underwent x-ray of pelvis due to low back pain.Impression: stable appearance of the pelvis.No fracture or malalignment.Post surgical changes involving the lower lumbar spine.On (b)(6) 2011: patient presented with complaint of chronic low back pain and right shoulder pain.Assessment: chronic low back pain with history of lumbar fusion and has persistent pain component of lumbar radiculopathy; right shoulder pain secondary to supraspinatus tendinosis and bursitis.On (b)(6) 2012: patient presented with complaint of low back pain.Assessment: chronic low back pain with a history of lumbar fusion; right shoulder pain from supraspinatus tendinosis and bursitis.On (b)(6) 2012, patient underwent x-ray of hip and pelvis due to left hip pain and instability.Interpretation: there is no evidence of fracture or other post-traumatic change involving the left hip.On (b)(6) 2012: patient presented with complaint of chronic low back pain and right knee pain.Assessment: chronic low back pain with resolved left lumbar radiculopathy.He has a history of lumbar fusion; persistent right knee pain, likely due to ¿djd¿ as he has history of prior knee replacement in the contralateral knee.On (b)(6) 2012, (b)(6) 2013: patient presented with complaint of right knee pain and chronic low back pain.Assessment: chronic low back pain with history of lumbar fusion; chronic right knee pain most likely from ¿djd¿ x-ray is pending.On (b)(6) 2013: patient presented with complaint of chronic low back pain and right knee pain.Assessment: chronic low back pain with history of lumbar fusion from l2-l5.Suspect left si joint dysfunction; chronic right knee pain from beginning djd.On (b)(6) 2014: the patient underwent x-ray myelogram of lumbar spine due to low back pain and leg pain.Successful fluoroscopic-guided lumbar myelogram the patient also underwent ct of lumbar spien without contrast.Impression: extensive postoperative changes status post l2 through s1 anterior and posterior fusion.Posterolateral and anterior fusion mass appears intact; the hardware is normal in location and appearance; at the l4-l5 level, osseous spurring is seen, mildly indenting the posterolateral right-sided thecal.On (b)(6) 2014: the patient underwent pelvis inlet/outlet exam due to back pain and sciatica and sacroiliitis.Summary: extensive multilevel fusion of the lumbar spine is noted; mild degenerative changes of each s1 joint.No acute osseous abnormality.The patient also underwent x-ray of lumbar spine complete with flexion and extension.Summary: 5 lumbar vertebrae; extensive solid intervertebral fusion from l2 through s1.Hardware is intact; no acute abnormality is seen.No subluxations are evident.The patient also underwent x-ray of thoracic spine three views.Summary: no acute finding; modest loss of height of t11 is unchanged, possibly developmental; mild multilevel degenerative disk disease.On (b)(6) 2014 patient presented for office visit.On (b)(6) 2014: the patient was pre-operatively diagnosed with anxiety and symptomatic bilateral sacroiliac joint arthritis and underwent the following procedures: iv conscious sedation for a total of 30 minutes time, 6 mg of versed and 50 mg of fentanyl; bilateral sacroiliac joint injections with formal arthrogram; fluoroscopic imaging of patient lumbosacral spine during bilateral sacroiliac joint injections with formal arthrograms.On (b)(6) 2014, patient underwent x-ray of lumbar spine due to trauma and pain.Impression: stable post-op changes without acute fracture or subluxation.On (b)(6) 2014, (b)(6) 2015, (b)(6) 2016: patient presented for office visit.On (b)(6) 2015: patient underwent spinal neuro-receiver implant.
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Event Description
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It was reported that on: (b)(6) 2007: the patient presented with moderate internal hemorrhoids.Benign appearing colon polyps and underwent right colonoscopy snare polypectomy.Impression: the only finding on this exam that would explain internal bleeding is internal hemorrhoids.Three benign appearing polyps were seen and removed.On (b)(6) 2008: the patient presented with right knee medial meniscus tear and degenerative arthritis of the right knee.The patient underwent right knee arthroscopy, partial medial meniscectomy, chondroplasty of the mediofemoral condyle, chondroplasty of the trochlea, chondroplasty of the patella, micro-fracture of the trochlea.No patient complications were reported.On (b)(6) 2008: the patient presented with left knee degenerative arthritis with medial meniscal tear and underwent left knee arthroscopy with partial meniscectomy, chondroplasty of the medial femoral condyle, chondroplasty of the patella.No patient complications were reported.On (b)(6) 2010: the patient presented with left knee degenerative arthritis.The patient underwent portable radiographs of the left knee.On (b)(6) 2010: the patient was discharged.On (b)(6) 2010: the patient presented for follow up and underwent triple phase bone scan of the lumbar spine and spec of the lumbar spine.Impressions: portions of the sacrum are obscured by bowel gas.Left total knee arthroplasty without complications.The patient underwent radiographic study of lumbar spine for comparison with the results of (b)(6) 2009.Impression: re-demonstrated extensive laminectomy and posterior fusion spanning l2-s1 with paired pedicle screws and paired tension rods.Intervertebral spacing devices in stable alignment.Mature postero-lateral bone graft re-demonstrated.No hardware complications or acute fracture was identified.Partial fusion of the l3-4, 4-5, and 5-1 interspaces.There was mild persistent degenerative disk space narrowing at l2-3 disk space at l1-2 is preserved.Re-demonstrated moderate degenerative disk changes of lower thoracic spine t11-12 and t10-11.Probable significant neural foraminal encroachment at l4-5 and l5-s1 in part related to hyper-trophic facet osteo-arthropathy and partly related to bone graft potentially.With flexion and extension, relatively little movement was noted.There were no worrisome subluxations.The patient also underwent radiological study of anterior-posterior pelvis due to left low back pain and leg pain.Impression: no acute fracture or misalignment.Mild degenerative irregularity of the sacro-iliac joints.Mineralization within normal limits.Post surgical changes of the lower lumbar spine.Portions of the sacrum obscured by bowel gas.
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Event Description
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It was reported that on (b)(6) 2007: the patient underwent ct of abdomen/pelvis.On (b)(6) 2007: the patient underwent ct of abdomen, limited study.On (b)(6) 2009: the patient underwent x-ray of lumbar spine.Impression: post-surgical changes from l2 through s1.No acute osseous findings demonstrated.On (b)(6) 2011: the patient underwent x-ray of right femur.Impression: probable soft tissue foreign body in the proximal right thigh postero-laterally.On (b)(6) 2012: the patient underwent x-ray of left ankle due to lateral pain in left ankle.Impression: mild apparent left lateral ankle soft tissue swelling.Otherwise, negative left ankle films.On (b)(6) 2013: the patient underwent x-ray of left knee status post knee replacement, unremarkable.On (b)(6) 2014: the patient presented for follow up for hypertension.On (b)(6) 2014: the patient presented for an office visit to consult with respect to long term, tobacco use.On (b)(6) 2014: the patient underwent x-ray of right knee due to history of post-op arthroplasty for arthritis.Impression: right total knee arthroplasty.The patient presented with right knee degenerative joint disease and underwent right total knee replacement.No patient complications have been reported.On (b)(6) 2015, (b)(6) 2016: patient presented for office visit.Musculoskeletal study: positive for low back pain, weakness.Diagnosis: pain in right shoulder.Cervicalgia.Long term (current) use of opiate analgesic.Other inter-vertebral disc degeneration, lumbar region.Spinal instabilities, lumbosacral region.Spondylosis without myelopathy or radiculopathy, lumbar region.On (b)(6) 2014: the patient presented with syndrome, post-laminectomy, lumbar.Facet joint pain, lumbosacral.Lumbar radiculopathy.Other specified code and underwent spinal cord stimulator trial.On (b)(6) 2015: patient presented with syndrome, post-laminectomy, lumbar.Facet joint pain, lumbosacral.Lumbar radiculopathy.Other specified code and underwent spinal neuro-receiver implant.On (b)(6) 2015: the patient underwent mri of right shoulder due to indication of pain in shoulder joint.Impression: deep partial undersurface tear of the supraspibatus.Partial intra-substance tear infraspinatus.Degenerative changes acromioclavicular joint.Small joint effusion.Mild glenohumeral osteoarthritis.On (b)(6) 2015: the patient presented for an office visit due to chief complaint of low back pain.Impression: right shoulder rotator cuff strain with mild adhesive capsulitis.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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