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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Abdominal Pain (1685); Chest Pain (1776); Cyst(s) (1800); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Edema (1820); Embolus (1830); Headache (1880); Hematoma (1884); Hypoxia (1918); Incontinence (1928); Infiltration into Tissue (1931); Irritation (1941); Neuropathy (1983); Overdose (1988); Pain (1994); Pleural Effusion (2010); Respiratory Distress (2045); Scarring (2061); Swelling (2091); Synovitis (2094); Weakness (2145); Tingling (2171); Stenosis (2263); Injury (2348); Depression (2361); Reaction (2414); Numbness (2415); Neck Pain (2433); Prolapse (2475); Ambulation Difficulties (2544); Claudication (2550); Hematuria (2558); Fibrosis (3167)
Event Type  Injury  
Manufacturer Narrative
(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.If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2004: the patient was admitted for elective treatment of low back pain.The patient underwent ct of lumbar spine.Impression: status post surgery at l3-l4 and l4-l5.Early fusion appears to be occurring.There is a small central/left focal disc herniation at l5-s1.It is a disc protrusion without extruded disc material.Bridging bone osteotype on the right side extending from l3-l4.Slight compression of the right l4 nerve root.The patient presented with status post fusion l3-l4 and l4-l5 with degenerative disc disease l5-s1.The patient underwent removal of hardware from l3-l4-l5 with evaluation of fusion mass and revision of fusion l3-l4-l5-s1 via bilateral posteriolateral technique with posterior lumbar interbody fusion of l5-s1 with bilateral pedicle screw instrumentation and bmp infuse product with local autogenous bone graft and mastergraft under fluoroscopic guidance with intra-op evoked emg monitoring.Post-op diagnosis: status post fusion l3-l4 and l4-l5 with degenerative disc disease; l5-s1 with probable pseudoarthrosis of the lumbar spine.As per operative notes, ¿these areas were decorticated with the bur and the bmp sponge product was placed into the lateral gutter after it was rolled around chips of cortical cancellous bone and master graft.Additional bonegraft was placed into the lateral gutter forming a confluence of bone between the decorticated transverse processes for posterolateral fusion to occur.¿ no intra-operative complications were reported.On (b)(6)2004: the patient was discharged.On (b)(6) 2004: the patient presented for an office visit status post fusion l3 to s1.On (b)(6) 2005: patient presented with complaint of pain in his lower back and numbness in his right leg.On (b)(6) 2005, (b)(6) 2006, and (b)(6) 2006: patient presented with complaint of pain in his left knee.On (b)(6) 2005 and (b)(6) 2006: patient presented with complaint of pain in his lower back and pain in his left thigh, left knee.On (b)(6) 2006: the patient underwent mri of the left knee.Impression: solitary multi-obulated vs multiple closely apposed predominantly posteriorly situated intra-articular masses.Small left knee joint effusion.Grade ii chondromalacia patella.No evidence of a meniscal tear.On (b)(6) 2006, on (b)(6) 2007, (b)(6) 2007, (b)(6) 2007, (b)(6) 2008, (b)(6) 2008, (b)(6) 2010, and (b)(6) 2010: patient presented for a follow up visit with complaint of pain his lower back and left leg.On (b)(6) 2006: patient presented with complaint of trouble standing and walking or putting weight on the left leg.He also complained of pain and clicking of his left knee.Patient x-rays were taken which showed an ossicle in superior lateral aspect of hip.On (b)(6) 2006: patient presented with complaint that his left knee buckled and developed swelling of his knee.On (b)(6) 2006, (b)(6) 2007, and (b)(6) 2007: patient presented with complaint of pain in his left knee and had trouble walking.On (b)(6) 2007: the patient presented with internal derangement of the left knee.Post-op diagnosis: bucket-handle tear of lateral meniscus; synovitis of the knee; chondral defect of lateral tibial plateau; tear along anterior horn of medial meniscus.The patient underwent arthroscopic surgery with partial lateral meniscectomy, medial meniscectomy, arthroscopic surgery with synovectomy of the knee, arthroscopis surgery with chondroplasty of the lateral tibial plateau.On (b)(6) 2007: patient underwent arthroscopic surgery of the left knee.Diagnosis: bucket handle tear involving the posterior horn of the lateral meniscus; chondral defect of the tibial plateau, 5mm; partial tear of the anterior horn of the medial meniscus; synovitis.Procedures patient underwent: partial medial and lateral meniscectomy; complete synovectomy; diagnostic arthroscopy; chondroplasty of lateral tibial plateau.On (b)(6) 2008: patient underwent microdiscectomy of lumbar spine.On (b)(6) 2008: the patient underwent mri of left knee.Impression: moderate degenerative changes of the trochlea predominantly medially and centrally with mild degenerative thinning of the femorotibial compartments.There is a horizontal tear in the posterior horn of lateral meniscus.On (b)(6) 2008: patient presented with complaint of pain in his left knee with stiffness.On (b)(6) 2008: the patient underwent mr arthrography of the left knee.On (b)(6) 2008: patient presented with complaint of pain in his left knee, pain in back of knee, worse at fibula head, posterior, along the peroneal nerve.On (b)(6) 2008: patient underwent arthroscopic surgery of the left knee.Diagnosis: peripheral tear of the posterior horn of the lateral meniscus, with scar tissue; additional tear of the posterior of the posterior horn of the lateral meniscus; tear of the anterior horn of the medial meniscus; synovitis of the medial joint, lateral joint, patellofemoral joint and intercondylar notch; chondromalacia of the patellofemoral joint.Procedures patient underwent: repair of a peripheral partial detachment of the posterior horn of the lateral meniscus; partial medial and lateral meniscectomy; complete synovectomy; diagnostic arthroscopy with synovial biopsy; abrasion arthroplasty of the patellofemoral joint.On (b)(6) 2008: patient presented with complaint of pain in the back of left calf.On (b)(6) 2008: the patient underwent ct of lumbar spine.Impression: no evidence of disc herniation identified.Status post spinal fusion involving l3, l4, l5 as well as s1.Status post laminectomy observed at l4 and l5.The patient also underwent lumbar myelogram.Impression: status post spinal fusion.No evidence of disc herniation.On (b)(6) 2009: patient presented for a follow up visit with complaint of pain in his right wrist and swelling.On (b)(6) 2009 patient underwent the following procedures: excision of right wrist volar ganglion cyst with extensive exploration of radial artery and mobilization of the radial artery as well as excision of soft tissue mass in the right palm to treat the pre-op diagnosis: right wrist volar ganglion cyst, right hand mass, right wrist pain, and right hand pain.On (b)(6) 2009: patient presented for a follow up visit with complaint of incision about his right wrist.On (b)(6) 2009: patient presented for a follow up visit with complaint of pain in his right hip when walking.On (b)(6) 2009: patient presented for a follow up visit with complaint of his leg giving out.Patient had progressive weakness of his left lower extremity.On (b)(6) 2010: patient underwent ct lumbar myelogram due to chronic pain.Postoperative lumbar fusion.Impression: status post l5 laminectomy.Status post l3-s 1 posterior spinal and interbody fusion.No evidence of abnormal compression of thecal sac or spinal stenosis.On (b)(6) 2010: the presented for a follow-up visit due to his back and pain into his left leg.He had trouble standing and walking.He has radicular pain that is persistent.Mri studies were done and showed an intramedullary space lesion.There were postoperative changes seen at l3-l4 and l5-s1 and no sign of residual disc herniation.X-rays were taken of the lumbosacral spine and showed effusion between l3 to sl.There were three levels of pedicle screw fixation.There was slight drift of the pedicle screws on the left side to the spinal canal.On (b)(6) 2010: patient underwent mri study of the lumbar spine with and without contrast.Impression: no significant change since previous study (b)(6) 2007.Postoperative changes l3-l4, l4-l5 and l5-s1.No evidence of residual or recurrent disc herniation.On (b)(6) 2010: patient presented due to nerve condition studies.Impression: the electrodiagnostic studies performed today are consistent with chronic l5 and s1 radiculopathy on the left with some mild acute worsening of s1 on the right side.On (b)(6) 2010: patient underwent spiral ct of the lumbar spine with contrast.Impression: l1-l2 small right paracentral calcified disc herniation.This causes mild compression on the adjacent thecal sac.There is minimal narrowing of the right neuroforamen secondary to an annular bulge component.L2-l3 level, there is preservation of the intervertebral disc space.There is an annular bulge at this level which causes mild nan-owing of the ventral subarachnoid space.There is mild narrowing of both neuroforamen at this level.The patient is status post posterior spinal fusion ofl3 through s1 with 4 sets of pedicle screws and 3 interbody spacers.L3-l4 level, a laminectomy is present.A cage spacer is present within the disc space.There is some artifact at this level limiting the evaluation.The pedicle screws appear intact.Facet arthritis is present at this level.There is mild narrowing of the left neuroforamen.L4-l5 mild ridge formation posteriorly to the right of midline.This causes slight posterior displacement of the right ventral nerve root.There is mild narrowing of both neuroforamen at this level secondary to osteophytes which project off the endplates.L5-s 1 small calcified ridge or disc noted posteriorly slightly to the left of midline.This causes mild narrowing of the adjacent ventral subarachnoid space.There is mild narrowing of the right neuroforamen.On (b)(6) 2010 the patient underwent x rays of the lumbar spine.Impression: post operative changes lumbar spine.On (b)(6) 2010 the patient underwent lumbar myelogram.Impression: status post l5 laminectomy.Status post l5 laminectomy.Status post l3-s1 posterior spinal and interbody fusion.No evidence of abnormal compression of thecal sac or spinal stenosis.On (b)(6) 2010 the patient underwent x rays of the lumbar spine.Impression: there is no significant interval change in appearance since the prior exam.On (b)(6) 2010 the patient underwent x rays of the chest.Impression: no pneumonia.Faint lucency seen projecting over the medial aspect of the right hemidiaphragm which is likely artifactual if the patient is asymptomatic or not recently post abdominal surgery.On (b)(6) 2011 patient presented for a follow-up visit due to parasthesisas of his feet.He is walking with difficulty and with pain into his lower extremities.He complains of pain in his lower back.X-rays were taken of his left knee; ap, lateral and skyline views.There were no loose bodies seen.There was no fracture seen and there was slight spurring seen.There was no narrowing of the joint space.On (b)(6) 2010 patient presented for a follow-up visit due to pain in his lower back pain and pain down his left leg with numbness.He had persistent numbness and pain.An mri study was done of the lumbar spine with contrast on (b)(6) 2010.A ct scan was done of the lumbar spine on (b)(6) 2010.The study showed status post posterior spinal fusion of l3 through s1 with 4 sets of pedicle screws and 3 interbody spacers.The pedicle screws were intact.X-rays were taken of the lumbosacral spine and showed cage and pedicle screws.These are masses seen laterally on the right side and left side.Lateral view showed no screws in the foraminal spaces and/or in the spinal space.On (b)(6) 2010 and (b)(6) 2010: patient presented for a follow up visit with complaint of pain in his back.On (b)(6) 2010 patient underwent ct lumbar myelogram.Alignment and hardware intact.Solid l3-s1 posterior bony fusion along posterior elements.Status post l3-l4 l5-s1 interbody fusion with bone graft.On (b)(6) 2010 patient presented for a follow-up visit due to some neurological condition.On (b)(6) 2010: patient presented for a follow up visit with complaint of pain in his back and pain into his left thigh and right buttocks.On (b)(6) 2010, (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, (b)(6) 2012, (b)(6) 2012: per billing records, patient presented for office visit.Diagnosis: displacement of lumbar intervertebral disc without myelopathy; thoracic or lumbosacral neuritis or radiculitis, unspecified; abnormality of gait; hereditary progressive muscular dystrophy.On (b)(6) 2010 patient underwent chest pa/lat 2v.Impression: no pneumonia, faint lucency seen projecting over medial aspect of right hemidiaphragm which is likely artifactual if the patient is asymptomatic or not recently post abdominal surgery.On (b)(6) 2010 patient underwent the following surgeries: removal of hardware, lumbar spine; inspection of fusion mass; revision laminectomy l4 -5 to treat the following pre-op diagnosis: painful hardware lumbar spine with associated stenosis.On (b)(6) 2010 patient underwent spine w/o contrast.Impression: status post posterior decompression from the level of l3 to the s1; l5-s1: no central canal stenosis noted.There are posterior facet hypertrophic changes as well as hypertrophic changes surrounding the right pedicle resulting in moderate-to-severe right foramina! stenosis, unchanged from the prior ct scan dated (b)(6) 2010.Severe posterior facet hypertrophic change is noted from level of l2-l3 to l4-l5 resulting in mild to moderate foraminal stenosis as described above.Edema noted within the soft tissues superficial to the exiting l4 and l5 vertebral bodies in the surgical bed.This is nonspecific in nature and correlation with point tenderness is recommended.On (b)(6) 2011 the patient underwent x rays of the lumbar spine.Impression: status post l2-5 laminectomies.Status post removal of pos terior hardware from l3-s1.Status post interbody fusion l3-4 to l5-s1.Satisfactory lumbar alignment.On (b)(6) 2011 the patient underwent x rays of the left knee.Impression: no evidence of acute cortical fracture or dislocation.The patient also underwent x rays of the lumbar spine.Impression: no significant change.On (b)(6) 2011 patient underwent lumbar spine 2v.Impression: no significant change.On (b)(6) 2011 patient underwent lumbar spine 2v.Impression: status post l2-l5 laminectomies.Status post removal of posterior hardware from l3-s1.Status post interbody fusion l3-l4 to l5-s1.Satisfactory lumbar alignment.On (b)(6) 2011 patient presented for an office visit due to his left knee will buckle.X-rays were taken of his left knee in rays were taken in standing position.The medial joint with spurring of the ap and lateral view.X-rays show narrowing of tibial eminence.On (b)(6) 2011 and (b)(6) 2011: patient presented for a follow up visit with complaint of pain in his lower back and his right hip.On (b)(6) 2011: patient presented for a follow up visit with complaint of paresthesias of his feet.On (b)(6) 2011 patient underwent mri of lumbar spine.Impression: status post posterior decompression from the level of l3 to the s1; l5-s1: no central canal stenosis noted.There are posterior facet hypertrophic changes as well as hypertrophic changes surrounding the right pedicle resulting in moderate-to-severe right foraminal stenosis, unchanged from the prior ct scan dated (b)(6) 2010.Severe posterior facet hypertrophic change is noted from level of l2-l3 to l4-l5 resulting in mild to moderate foraminal stenosis as described above.Edema noted within the soft tissues superficial to the exiting l4 and l5 vertebral bodies in the surgical bed.This is nonspecific in nature and correlation with point tenderness is recommended.On (b)(6) 2011 the patient was presented for office visit with increasing pain right radiculopathic l5 and s1 pain.On (b)(6) 2012 patient presented for a follow-up visit due to back pain.He has pain in his lower back and pain into his buttocks.The pain down his legs has become significant.He was admitted to (b)(6) hospital.On (b)(6) 2012 and (b)(6) 2012: patient presented for a follow-up visit due to persistent back pain in his lower back and pain into his legs.On (b)(6) 2012 the patient underwent x rays of the lumbar spine.Impression: no significant change.On (b)(6) 2012 patient underwent ct lumbar spine w/o contrast.Impression: solid fusion l3-s1.Right foramen narrowing l3-l4, l5-s1 secondary to bone encroachment on the foramina.No disc herniation or spinal stenosis.On (b)(6) 2012 patient underwent ct scan thoracic spine.Impression: mild dorsal cord compression t3-t4 related to thickening of the ligamentum flavum.Mild cord compression t5-t6 related to small central disc herniation and thickening of the ligamentum flavum.On (b)(6) 2012 patient underwent ct scan of cervical spine.Impression: small central/left disc herniation c3-c4 with mild left-sided cord compression and compression of the left c4 nerve root.Small, central, partially calcified disc herniation c4-c5, c5-c6 and c6-c7 without nerve root or cord compression.On (b)(6) 2012 the patient underwent myelogram of the cervical spine, lumbar spine and thoracic spine.Impression: mild dorsal cord com pression t3-t4 related to thickening of the ligamentum flavum.Mild cord compression t5-t6 related to small central disc herniation and thickening of the ligamentum flavum.The patient also underwent ct of cervical spine.Impression: small central/left disc herniation c3-c4 with mild left-sided cord compression and compression of the left c4 nerve root.Small, central, partially calcified disc herniation c4-c5, c5-c6, c6-c7 without nerve root or cord compression.29 feb2012 patient presented for an office visit due to back pain.Impression: status post l3-s1 fusion with decompression a minimal right convexity thoracic scoliosis.On (b)(6) 2012 patient underwent x-ray of lumbosacral spine bending view.Impression: no acute osseous abnormality of the lumbosacral spine.On (b)(6) 2012 patient presented for a follow-up visit due to pain in his back and pain down his legs.He feels weakness in his left leg.Patient underwent x-rays were taken of his lumbosacral spine ap and lateral views.The cages are in position at l3-l4, l4-l5 and l5-s1.On (b)(6) 2012 patient underwent x-ray of spine scoliosis erect views.Impression: minimal convex right scoliosis that improves with rightward bending and increases with leftward bending.Status post laminectomies from l3 to s1 with intervertebral spacers at l3-l4, l4-l5 and l5-s1.On (b)(6) 2012 and (b)(6) 2012: the patient presented for a follow up visit for severe back pain.On (b)(6) 2012 patient had persistent pain in his lower back and the pain goes into his extremities.He had paresthesias in his extremities.He felt like his left leg was completely numb.Patient underwent x-rays of lumbosacral spine and showed straightening of the lumbar spine from l1-l5.There are spur formations seen at levels l5-sl, l4-l5, and l3-l4.There is loss or inability to identify the spinal canal as well as the foraminal spaces as seen on lumbosacral spine at l3-s1.L4-l5 and l5-s1.Oblique view as far as the cages are present at level l3-l4, x-rays were taken of his pelvis; ap view.The sacroiliac joints are intact.There is spinal stenosis with hamstring tightness and perhaps foraminal stenosis as evident on x-rays.On (b)(6) 2012 patient underwent ct myelogram of his lower back to evaluate for spinal stenosis and/or neural foraminal stenosis.Patient underwent mri of spine with and without contrast on (b)(6) 2010.On (b)(6) 2012 patient presented with a ct scan of his lumbar spine on (b)(6) 2012.On (b)(6) 2012 patient underwent x-rays of left knee: ap and lateral view.There was no fracture seen about the left knee.On (b)(6) 2012 patient underwent ct scan of lumbar spine.Impression: no significant interval change since study on (b)(6) 2012, solid anterior and posterior interbody fusion l3-s1.Right foramen narrowing l3-l4, l4-l5 secondary to bony encroachment on the foramina, no disc herniation or spinal stenosis.Mild, stable, degenerative changes at sacroiliac joints.On (b)(6) 2012 patient underwent lumbar myelogram.Impression: lumbar myelogram performed without immediate complication.On (b)(6) 2012: patient underwent-ray of chest.Impression: no evidence of acute infiltrate.Patient also underwent ecg.On (b)(6) 2012: patient presented with pre-operative diagnosis of: history of lumbar decompression and fusion l3-s1; recurrent lower back pain, recurrent lumbar stenosis l4-l5 and l5-s1 and bilateral lumbar radiculopathy, chronic left foot drop and underwent bilateral redo l3-l4 and l5-s1 laminectomy for spinal canal lateral recess decompression, for decompression of bilateral l3-s1 nerve roots, microsurgical dissection with operative microscope and microsurgical technique.Indications: patient with persistent back pain and lumbar radiculopathy has undergone multiple lumbar surgeries, but remained with significant back pain and sciatica.Patient also has left greater than right leg weakness.Emg demonstrated l5-s1 radiculopathy bilaterally, left greater than right.Ct myelogram demonstrated a large residual osteophyte on the right side in the lateral recess extending into the l5-s1 neural foramen with l5 nerve root impingement.Findings: dense paraspinal and epidural fibrosis; extremely sensitive left sided lumbar nerve root left l5-s1; scarred down dura with dural defect centrally and towards the right at l5-s1.There were no patient complications.On (b)(6) 2012: post operative day 1: patient does describe significant pain with movement.On (b)(6) 2012: patient was discharged.On (b)(6) 2012 patient underwent x-rays of lumbar spine and showed cages in the spine to keep the spine open and maintain foraminal spaces.On (b)(6) 2013 patient underwent x-rays of left knee in ap, lateral and skyline view.On (b)(6) 2013 patient presented due to lower back problems.He underwent x-rays of thoracic spine.On (b)(6) 2013 patient underwent mri of the lumbar spine without contrast.Impression: status post posterior laminectomy and decompression from the level of l3 to the level of s1.Postsurgical changes noted with a 6.4 x 2.7 x 2.7 cm postsurgical fluid collection in the surgical bed causing mass effect on the posterior aspect of the thecal sac with resultant mild central canal stenosis at the level of l5.Increased soft tissue within the right neural foramen at the level of l5-s1 resulting in moderate-to-severe foraminal stenosis likely related to postsurgical granulation tissue.Moderate bilateral foraminal stenosis noted at l4-l5.Moderate right foraminal stenosis at l3-l4; small left foraminal/extraforaminal protrusion at l2-l3 causing mild to moderate foraminal stenosis; disc bulge with a right paracentral protrusion at ll-l2 flattening the right lateral recess and minimally reaching the descending right l2 nerve root in the canal.Resultant mild central canal stenosis; on (b)(6) 2013 patient underwent x-ray of thoracic spine.Impression: no evidence of fracture, vertebral compression or destructive bony lesion.Mild spondylosis deformans.If clinically indicated, further evaluation is recommended.On (b)(6) 2013 patient had pain into his back and pain into his left lower extremity.He said his back has become worse in the last 3-4 weeks.He had trouble extending his back and straightening up.On (b)(6) 2013 patient presented for a follow-up visit due to lower back pain.The pain also radiates to his right hip and buttock.Impression: lumbar post-laminectomy syndrome; lumbar-thoracic radiculitis.11 mar 2013, 18 mar 2013 patient had trouble with his back.He can¿t get himself straight.On (b)(6) 2013 patient indicated that he is not doing well.He had pin in his neck and upper back.He had trouble standing and walking.He is unable to straighten himself out on (b)(6) 2013 patient¿s final diagnosis: epidural fluid, evacuation satisfactory for evaluation no malignant cells identified.Markedly hypocellular specimen with scant lymphocytes, and proteinaceous material present.Impression: status post posterior laminectomy and decompression from the level of l3 to the level of s1.Postsurgical changes noted with a 6.4 x 2.7 x 2.7 cm postsurgical fluid collection in the surgical bed causing mass effect on the posterior aspect of the thecal sac with resultant mild central canal stenosis at the level of l5.Increased soft tissue within the right neural foramen at the level of l5-s1 resulting in moderate-to-severe foramina! stenosis likely related to postsurgical granulation tissue.Moderate bilateral foramina! stenosis noted at l4-l5.Moderate right foraminal stenosis at l3-l4.Small left foraminal/extraforaminal protrusion at l2-l3 causing mild to moderate foraminal stenosis.Disc bulge with a right paracentral protrusion at ll-l2 flattening the right lateral recess and minimally reaching the descending right l2 nerve root in the canal.Resultant mild central canal stenosis.Patient underwent radiological test of lumbar spine during an epidural aspiration procedure.On (b)(6) 2013 patient presented for a follow-up visit due to pain in his low back and pain down his left leg.He also had weakness of his right and left leg.
 
Manufacturer Narrative
Event description continued: (b)(6) 2013 patient presented for a follow-up visit.In reviewing the mri report dated (b)(6) 2013, at l3-l4, l4-l5 and l5-s1 the· patient was status post posterior decompression with discectomy and disc spacer placement.(b)(6) 2013 patient presented for a follow-up visit due to pain in his head and pain throughout his whole body.He had pain throughout his spine as well as pain into his legs.(b)(6) 2013 patient underwent mri thoracic spine without contrast due to neck pain, back pain, leg pain.Impression: mild ventral cord compression at t5-t6 secondary to small disc protrusion.Ventral displacement of the cord at t3-t4, tl 0-tll related to facet joint osteoarthritis.There is no paraspinal mass.(b)(6) 2013 patient underwent mri study of the cervical spine without contrast.Impression: small central/right disc protrusion c6-c7 without cord or nerve root compression.Small central disc protrusion c4-c5 with slight compression of ventral aspect of the cord.Small central/left disc protrusion c3-c4 with compression of the left c4 nerve root.(b)(6) 2013 patient underwent mri of the brain with contrast with csf analysis.Impression: unremarkable mri of brain.There is no mass lesion, demyelination, acute infarction or hemorrhage.There is no abnormal enhancement.There is no meningeal disease.There is no tonsillar herniation.The ¿csf¿ analysis was remarkable.(b)(6) 2013 patient presented for a follow-up visit due to complain of pain in the lower back.The patient had ct scan of his neck and thoracic spine.(b)(6) 2013, (b)(6) 2013: the patient presented with spinal tap reactions, headaches, status post-operative, post laminectomy syndrome and low back pain syndrome.(b)(6) 2013 patient presented for a followup visit due to pain in his back and pain that goes through his left leg.X-rays were taken of the lumbar spine; ap view and lateral view$.There is a normal dorsal lumbar curvature.The discs spaces are maintained.There is no sign of any instability of the spine on flexion views.Ap view shows hypertrophic changes of the spine.(b)(6) 2013: patient underwent ¿¿scoliosis sp survey ap/lat complete¿ due to scoliosis¿.Impression: frontal and lateral views of the thoracic and lumbar spine obtained with the perfect erect.Patient is status post spine surgery with disk spacers noted at l3-l4, l4-l5, l5-s1.(b)(6) 2013: patient underwent ¿scoliosis sp survey ap/lat complete¿ due to scoliosis.Impression: status post spine surgery with disk spacers noted.No significant change.(b)(6) 2013: patient presented for a follow up visit with complaint of pain in his back and pain, weakness down his leg.(b)(6) 2013: patient presented for a follow up visit with complaint of pain down his buttocks.(b)(6) 2014: patient presented for a follow up visit with complaint of pain in his right hand.(b)(6) 2014: patient presented for a follow up visit with complaint of pain in his back.(b)(6) 2014: patient presented for a follow up visit with weakness of his lower extremities and pain in back.X-rays were taken of left knee where there was some narrowing of medial joint, minimal on left knee.X-rays were also taken of lumbar spine which showed cages are in place with no displacement.(b)(6) 2014, and (b)(6) 2014: patient presented for a follow up visit with complaint of pain in his back and pain down his leg.Opinion: chronic lumbosacral derangement with cord compression and neural foramen impingement.(b)(6) 2013 patient presented for an office visit due to pain in the back and pain down in his legs.The patient has a painful lower back with difficulty with ambulation.(b)(6) 2013 patient presented for an office visit due to pain in his back and cannot stand erect.The patient has findings of sciatic nerve root irritation with weakness of his legs.(b)(6) 2014: the patient underwent mri of right wrist.Impression: ill defined soft tissue mass of the radial and slightly volar aspect of the distal forearm located in the deep subcutaneous fat.It may represent a ganglion cyst.Extensor carpi ulnaris tendinosis.(b)(6) 2014, (b)(6) 2015, (b)(6) 2016: the patient presented for an office visit.(b)(6) 2014: the patient underwent mri of the right wrist.(b)(6) 2014: the patient underwent ct scan of lumbar spine.Impression: post-operative changes compatible with a multilevel posterior lumbar spinal fusion; small peripherally calcified right paramedian disc herniation at the l1-l2 level; bilateral facet arthropathy (greater at the l2-l3 than the l1-l2 level); right-sided bony neuroforaminal narrowing at the l5-s1 level; congenital foreshortening of the pedicles of the inferior lumbar vertebral column; mild generalized bony de-mineralization.The patient also underwent ct of thoracic spine due to history of posterior lumbar fusion impression: no evidence of the thoracic disc herniation; multilevel posterior thoracic bony exostosis; central spinal canal stenosis (moderate at the t3-t4 and mild at the t5-t6 level); follow-up mr imaging of thoracic spine suggested.(b)(6) 2014: the patient underwent radiologic study of posterior-anterior and lateral chest due to history of right chest pain.Impression: negative exam.The patient also underwent ¿cta¿ of chest due to history of chest pain and shortness of breath.Impression: no evidence of pulmonary embolism.(b)(6) 2014: the patient presented for consultation regarding ongoing pain since an injury on (b)(6) 1997.The most recent ct scan of the thoracic and lumbar spine indicated no evidence of thoracic disk herniation, multi-level posterior thoracic exostosis, central spinal stenosis at t3/t4 and t5/t6.Ct scan of lumbar spine demonstrated post-operative changes with posterior lumbar spinal fusion, disk herniation at l1/l2, facet arthropathy l2/l3 greater than l1/l2 and bony demineralization.Mri of the lumbar spine status post posterior laminectomy, decompression l3 to s1 with post-surgical changes, moderate bilateral foraminal stenosis, disk herniation at l1/l2 and facet changes at l2/l3 level.(b)(6) 2014: patient underwent dorsal spine ap/ last 2 views, lumbosacral spine ap/ lat 2 or 3 views.Impression: thoracic spine.Mild spondylosis deformans.(b)(6) 2014: patient underwent x-ray of chest pa lateral.Impression: no acute infiltrate.(b)(6) 2014: the patient underwent ct of lumbar spine due to back pain and lower extremity pain.Impression: prior lumbar posterior decompression and inter-body fusion with evidence of solid interbody fusion at l3-4, l4-5, and l5-s1.The lateral fusion masses were intact, however there is discontinuity along the right l3-4 facet.Mild mass effect on the thecal sac at l5 may be related to scar tissue.Ligamentous and facet hypertrophy adjacent to the post-operative levels results in mild canal stenosis.Mild bilateral foraminal narrowing at the post operative levels due to the fusion masses.The patient also underwent successful ct guided myelography at l2-l3 with administration of 14cc of isovue 200 for ct myelogram.Further, the patient underwent ct of thoracic spine.Impression: no evidence of thoracic disc herniation; multi-level posterior thoracic bony exostosis; central spinal canal stenosis (moderate at the t3-t4 and mild at the t5-t6 level); follow-up mr imaging of thoracic spine suggested.(b)(6) 2014: patient underwent mri of cervical spine without contrast.Impression: no acute compression fracture or spondylolisthesis.Multilevel degenerative disc diseases, worst at c3-c4 and c4-c5, where there is canal, left lateral recess and mild foraminal narrowing.(b)(6) 2014: patient presented for a follow up visit with findings of sciatic nerve root irritation and weakness of his left lower extremity.(b)(6) 2014: patient presented for a follow up visit with complaint of pain in his lower back, about his buttock and sacral area.(b)(6) 2014: patient presented for a follow up visit with complaint of pain in his back and pain down his leg with weakness of his left leg.(b)(6) 2014: the patient underwent ct of stone due to indication of hematuria.Impression: no acute intra-abdominal or pelvic abnormality is identified; there is mild hepatomegaly and the liver is diffusely hypodense, most likely indicating fatty infiltration.Correlate with liver function test; there is no evidence of renal mass, abnormal renal calcifications or renal collecting system abnormality.The urinary bladder is only partially distended at the time of exam but no intra-luminal stones or masses are identified.(b)(6) 2014: the patient underwent x-ray of left hand due to history of rule out foreign body.Impression: no radiopaque foreign body.(b)(6) 2014: patient presented for a follow up visit.(b)(6) 2014: the patient underwent radiologic study of posterior-anterior and lateral chest.Impression: limited exam.No acute pathology.(b)(6) 2015: patient presented for a follow up visit for consultation of his lower back complaints.(b)(6) 2015: the patient presented for an office visit with chief complaints of intractable low back pain and underwent electro-diagnostic study.Impression: this was an abnormal study.Evidence of distal sensorimotor axonal polyneuropathy.(b)(6) 2015: patient presented for a follow up visit with still having pain in his lower back.Patient had abdominal pain and had difficulty moving his bowels.(b)(6) 2015: patient presented for a follow up visit had chronic pain in his back and his legs with repeated findings of spinal stenosis.Emg¿s were done which demonstrated distal sensorimotor axonal polyneuropathy.(b)(6) 2015: patient presented for a follow up visit with complaint of pain in his lower back and pain into his legs.(b)(6) 2015 the patient presented with evaluate low back pain.Spinal stenosis with neurogenic claudication for mri of the lumbosacral spine with and without gadolinium.Impression: status post laminectomies with intervertebral cages/grafts at l3-l4, l4-l5, l5-s1 with posterolateral fusion mass and focal fluid collection in the laminectomy defect mildly flattening the posterior aspect of the thecal sac; circumferential disc bulges and facet joint degenerative changes at ll-l2 and l2-l3; mild osteophyte disc protrusion extending caudally to the right of midline at ll-l2; bony bridging across the right anterolateral epidural region impinging the right anterolateral aspect of the thecal sac and the right lateral aspect of the thecal sac and causing right neural foraminal narrowing.(b)(6) 2015 patient underwent mri of the cervical spine to treat neck and arm pain.Impression: degenerative disc disease with spondylosis deformans; moderate broad-based disc protrusion to the left of midline at c3-4 indenting the left anterior aspect of the spinal cord and extending into left neural foramen causing moderate left neural foraminal narrowing; moderate central disc protrusion at c4-5 impinging the anterior aspect of the spinal cord; mild central disc protrusion at c5-6 indenting the thecal sac; mild disc protrusion slightly to the right of midline at c6-7 just touching the anterior aspect of the spinal cord.(b)(6) 2015: patient presented for a follow up visit.Patient had impingement of the spinal column as well as neural foramen.Patient also had findings of cystic lesion of spine in area of laminectomy.(b)(6) 2015: patient presented for a follow up visit where doctor indicated patient to lose weight.(b)(6) 2015: patient presented with complaint of pain in his neck and hand, more specifically the right long finger.X-rays were taken of right middle finger which revealed no fracture about the finger.X-rays were also taken of cervical spine, c1 to c6.There were degenerative disc seen of the mid-cervical spine.There was no subluxation of the vertebra.(b)(6) 2015: patient presented with complaint of extreme pain in his neck and pain into his arms.He also had lower back pain and pain into his legs.Patient has progressive neurological weakness in his lower extremities and has findings of compression and/or neuropathy of the lower extremities.(b)(6) 2015, (b)(6) 2015 patient presented for an office visit.(b)(6) 2015: patient presented with complaint of lower back pain and can hardly move his extremities.(b)(6) 2015: patient undergoes pain management.Opinion: patient has weakness of his lower extremities, secondary to lumbosacral derangement.(b)(6) 2015 patient presented with kyphosis, elbow crutched to help stabilize him.He was emotionally labile.His neurological status grossly of all motors around the hip, knees, ankles, hindfeet, midfeet and forefeet was 5/5.He had exquisite tenderness over the right iliolumbar enthuses.Patient had an injection of 1 cc of kenalog and 3cc of marcaine.(b)(6) 2015 patient underwent ct myelogram of the cervical, thoracic and lumbar spine without contrast due to chronic severe low back pain.Impression: cervical spine: multilevel disc/osteophyte and the cervical spine with mild canal stenosis and mild impingement upon the cervical spinal cord, most pronounced at c3-4, c4-5, and c5-6.Findings are similar appearance to the cervical spine mri of (b)(6) 2015.Thoracic spine: protrusion at t5-6 which mildly indents upon the spinal cord.Prominent multilevel facet arthropathy.Mild canal stenosis at c5-6, and t9-10, and t10-11.Overall no significant interval change from (b)(6) 2012.Lumbar spine: status post prior posterior decompression of l4-5 and discectomy and fusion of l3-s1.Small fluid collection within the laminectomy defect has decreased in size from (b)(6) 2015.Small chronic protrusion at l 1-2.At most mild central canal stenosis at the l 1-2 level.Multilevel foraminal stenosis.(b)(6) 2015 patient underwent lumbar puncture under fluoroscopic guidance.Impression: successful fluoroscopy guided lumbar puncture and administration of intra-thecal contrast.(b)(6) 2015: patient underwent ct myelogram done of the cervical, thoracic and lumbar spine.Study demonstrated multi-level disc/osteophyte of the cervical spine with mild canal stenosis and mild impingement upon the cervical spinal cord most pronounced at c3-4, c4-5 and c5-6.There was protrusion at t5-6, which mildly indents upon the spinal cord.There was prominent multilevel arthropathy.There was mild canal stenosis at c5-6, t9-t10 and t10-11.(b)(6) 2015: patient presented for a follow up visit.Opinion: patient has lumbosacral derangement and findings of neuroforamen compression.(b)(6) 2015 patient assessment reveled with disability.(b)(6) 2015 patient presented for an office visit.(b)(6) 2015 patient underwent ct of the head without contrast due to chronic severe headache.Impression : unremarkable ct of the head.(b)(6) 2015 the patient was admitted to the hospital.Impression: no large central pulmonary arterial vascular filling defects are evident, although evaluation of smaller more peripheral branches is limited by artifact and the degree of contrast-opacification.Problems: acute respiratory failure with hypoxia and hypercardia; drug overdose; degenerative disc disease; headache; diabetes.The patient underwent x rays of the chest.Impression: no large central pulmonary arterial vascular filing defects are evident, although evaluation of smaller more peripheral branches is limited by artifact and the degree of contrast-opacification.(b)(6) 2015 the patient was presented for office visit with headache.Impression: chronic pain on opiates, migraine headaches, presented to er with headache, neck/back pain, dyspnea on exertion.In er became hypoxic and somnolent.(b)(6) 2015 the patient was discharged from the hospital.Discharge diagnosis: acute respiratory failure with hypoxia and hypercarbia.(b)(6) 2016: patient presented for a follow up visit with complaint of pain in his neck and pain in his lower back.Patient had weakness of his lower extremities and need crutches for walking.Opinion: patient has lumbosacral derangement and findings of neuroforamen compression.(b)(6) 2016: patient presented for a follow up visit having chronic lower back derangement with neuropathy to his lower extremities.(b)(6) 2016: patient underwent mri cervical spine without contrast.Impression: degenerative changes, most prominently.C3-c4 asymmetric broad- based disc osteophyte complex to the left, which flattens the spinal cord and causes mild left neural foraminal narrowing.C4-c5 large broad based central disc osteophyte complex which flattens the spinal cord ventrally.(b)(6) 2016: the patient underwent ct of thorax due to chest pain.Impression: saddle pulmonary embolus with extensive clot extension into all lobes bilaterally.Thrombus in the right atrium.Evidence of right heart strain.(b)(6) 2016: patient underwent cxr ap with portable.Impression: mild chf.Mild cardiomegaly with left atrial enlargement.(b)(6) 2016: the patient presented for office visit status post anterior cervical discectomy and fusion.The x-ray demonstrated well seated cages.(b)(6) 2016: patient underwent us extremity limited.Impression: mass or thickening in or deep to the deep subcutaneous soft tissues at the medial left upper extremity.Main considerations include hematoma.No drainable fluid collection identified at the regions scanned.(b)(6) 2016: patient presented for a follow up visit with complaint of weakness of his left ankle and foot.He had a pulmonary embolus after his cervical procedure.(b)(6) 2016: the patient underwent mri of cervical spine without contrast due to myelopathy.Impression: degenerative changes, most prominently: c3-c4 asymmetric broad based osteophyte complex to the left which flattens the spinal cord and cause mild left neural foraminal narrowing.C4-c5 large broad based central disc osteophyte complex which flattens the spinal cord ventrally.Patient also underwent x-ray of chest.Impression: pulmonary vascular redistribution.Mild cardiomegaly with left atrial enlargement.No infiltrates, effusions or pneumothorax.(b)(6) 2016: the patient presented with: c4-5 and c3-4 disc herniation prolapse versus c4-c5 with large central disc prolapse with spinal stenosis and associated cervical spondylogenic myelopathy.The patient underwent the following procedures: anterior cervical discectomy, c4-c5; anterior cervical discectomy, c3-c4; insertion of cage at c3-c4 and c4-c5; anterior plating and anterior arthrodesis, c3, c4 and c5; three partial corpectomies at c3, c4 and c5.No complications were reported.(b)(6) 2016: the patient presented for follow up visit for persistent back pain.The patient underwent x-ray.(b)(6) 2016: patient underwent x-ray of chest due to chest pain.Impression: mild chf.Patient presented with chest pain and referred for pulmonary embolus underwent lung ventilation and perfusion scan.Impression: no evidence of pulmonary embolism.If information is provided in the future, a supplemental report will be issued.
 
Event Description
(b)(6) 2004: the patient was admitted for elective treatment of low back pain.The patient underwent ct of lumbar spine.Impression: status post surgery at l3-l4 and l4-l5.Early fusion appears to be occurring.There is a small central/left focal disc herniation at l5-s1.It is a disc protrusion without extruded disc material.Bridging bone osteotype on the right side extending from l3-l4.Slight compression of the right l4 nerve root.The patient presented with status post fusion l3-l4 and l4-l5 with degenerative disc disease l5-s1.The patient underwent removal of hardware from l3-l4-l5 with evaluation of fusion mass and revision of fusion l3-l4-l5-s1 via bilateral posteriolateral technique with posterior lumbar interbody fusion of l5-s1 with bilateral pedicle screw instrumentation and bmp infuse product with local autogenous bone graft and mastergraft under fluoroscopic guidance with intra-op evoked emg monitoring.Post-op diagnosis: status post fusion l3-l4 and l4-l5 with degenerative disc disease l5-s1 with probable pseudoarthrosis of the lumbar spine.As per operative notes, ¿these areas were decorticated with the bur and the bmp sponge product was placed into the lateral gutter after it was rolled around chips of cortical cancellous bone and master graft.Additional bonegraft was placed into the lateral gutter forming a confluence of bone between the decorticated transverse processes for posterolateral fusion to occur.¿ no intra-operative complications were reported.(b)(6) 2004: the patient was discharged.(b)(6) 2004: the patient presented for an office visit status post fusion l3 to s1.(b)(6) 2005: patient presented with complaint of pain in his lower back and numbness in his right leg.(b)(6) 2005, (b)(6) 2006, and (b)(6) 2006: patient presented with complaint of pain in his left knee.(b)(6) 2005, (b)(6) 2006: patient presented with complaint of pain in his lower back and pain in his left thigh, left knee.(b)(6) 2006: the patient underwent mri of the left knee.Impression: solitary multi-obulated vs multiple closely apposed predominantly posteriorly situated intra-articular masses; small left knee joint effusion; grade ii chondromalacia patella; no evidence of a meniscal tear.(b)(6) 2006, (b)(6) 2007, (b)(6) 2007, (b)(6) 2008, (b)(6) 2010, and (b)(6) 2010: patient presented for a follow up visit with complaint of pain his lower back and left leg.(b)(6) 2006: patient presented with complaint of trouble standing and walking or putting weight on the left leg.He also complained of pain and clicking of his left knee.Patient x-rays were taken which showed an ossicle in superior lateral aspect of hip.(b)(6) 2006: patient presented with complaint that his left knee buckled and developed swelling of his knee.(b)(6) 2006, (b)(6) 2007: patient presented with complaint of pain in his left knee and had trouble walking.(b)(6) 2007: the patient presented with internal derangement of the left knee.Post-op diagnosis: bucket-handle tear of lateral meniscus; synovitis of the knee; chondral defect of lateral tibial plateau; tear along anterior horn of medial meniscus.The patient underwent arthroscopic surgery with partial lateral meniscectomy, medial meniscectomy, arthroscopic surgery with synovectomy of the knee, arthroscopic surgery with chondroplasty of the lateral tibial plateau.(b)(6) 2007: patient underwent arthroscopic surgery of the left knee.Diagnosis: bucket handle tear involving the posterior horn of the lateral meniscus; chondral defect of the tibial plateau, 5mm; partial tear of the anterior horn of the medial meniscus; synovitis.Procedures patient underwent: partial medial and lateral meniscectomy; complete synovectomy; diagnostic arthroscopy; chondroplasty of lateral tibial plateau.(b)(6) 2008: patient underwent microdiscectomy of lumbar spine.(b)(6) 2008: the patient underwent mri of left knee.Impression: moderate degenerative changes of the trochlea predominantly medially and centrally with mild degenerative thinning of the femorotibial compartments.There is a horizontal tear in the posterior horn of lateral meniscus.(b)(6) 2008: patient presented with complaint of pain in his left knee with stiffness.(b)(6) 2008: the patient underwent mr arthrography of the left knee.(b)(6) 2008: patient presented with complaint of pain in his left knee, pain in back of knee, worse at fibula head, posterior, along the peroneal nerve.(b)(6) 2008: patient underwent arthroscopic surgery of the left knee.Diagnosis: peripheral tear of the posterior horn of the lateral meniscus, with scar tissue; additional tear of the posterior of the posterior horn of the lateral meniscus; tear of the anterior horn of the medial meniscus; synovitis of the medial joint, lateral joint, patellofemoral joint and intercondylar notch; chondromalacia of the patellofemoral joint.Procedures patient underwent: repair of a peripheral partial detachment of the posterior horn of the lateral meniscus; partial medial and lateral meniscectomy; complete synovectomy; diagnostic arthroscopy with synovial biopsy; abrasion arthroplasty of the patellofemoral joint.(b)(6) 2008: patient presented with complaint of pain in the back of left calf.(b)(6) 2008: the patient underwent ct of lumbar spine.Impression: no evidence of disc herniation identified.Status post spinal fusion involving l3, l4, l5 as well as s1.Status post laminectomy observed at l4 and l5.The patient also underwent lumbar myelogram.Impression: status post spinal fusion.No evidence of disc herniation.(b)(6) 2009, (b)(6) 2009: patient presented for a follow up visit with complaint of pain in his right wrist and swelling.(b)(6) 2009 patient underwent the following procedures: excision of right wrist volar ganglion cyst with extensive exploration of radial artery and mobilization of the radial artery as well as excision of soft tissue mass in the right palm to treat the pre-op diagnosis: right wrist volar ganglion cyst, right hand mass, right wrist pain, and right hand pain.(b)(6) 2009: patient presented for a follow up visit with complaint of incision about his right wrist.(b)(6) 2009: patient presented for a follow up visit with complaint of pain in his right hip when walking.(b)(6) 2009: patient presented for a follow up visit with complaint of his leg giving out.Patient had progressive weakness of his left lower extremity.(b)(6) 2010: patient underwent ct lumbar myelogram due to chronic pain.Postoperative lumbar fusion.Impression: status post l5 laminectomy.Status post l3-s 1 posterior spinal and interbody fusion.No evidence of abnormal compression of thecal sac or spinal stenosis.(b)(6) 2010 : the presented for a follow-up visit due to his back and pain into his left leg.He had trouble standing and walking.He has radicular pain that is persistent.Mri studies were done and showed an intramedullary space lesion.There were postoperative changes seen at l3-l4 and l5-s1 and no sign of residual disc herniation.X-rays were taken of the lumbosacral spine and showed effusion between l3 to sl.There were three levels of pedicle screw fixation.There was slight drift of the pedicle screws on the left side to the spinal canal.(b)(6) 2010: patient underwent mri study of the lumbar spine with and without contrast.Impression: no significant change since previous study (b)(6) 2007.Postoperative changes l3-l4, l4-l5 and l5-s1.No evidence of residual or recurrent disc herniation.(b)(6) 2010: patient presented due to nerve condition studies.Impression: the electrodiagnostic studies performed today are consistent with chronic l5 and s1 radiculopathy on the left with some mild acute worsening of s1 on the right side.(b)(6) 2010: patient underwent spiral ct of the lumbar spine with contrast.Impression: l1-l2 small right paracentral calcified disc herniation.This causes mild compression on the adjacent thecal sac.There is minimal narrowing of the right neuro-foramen secondary to an annular bulge component; l2-l3 level, there is preservation of the intervertebral disc space.There is an annular bulge at this level which causes mild nan-owing of the ventral subarachnoid space.There is mild narrowing of both neuroforamen at this level; the patient is status post posterior spinal fusion of l3 through s1 with 4 sets of pedicle screws and 3 interbody spacers; l3-l4 level, a laminectomy is present.A cage spacer is present within the disc space.There is some artifact at this level limiting the evaluation.The pedicle screws appear intact.Facet arthritis is present at this level.There is mild narrowing of the left neuroforamen; l4-l5 mild ridge formation posteriorly to the right of midline.This causes slight posterior displacement of the right ventral nerve root.There is mild narrowing of both neuroforamen at this level secondary to osteophytes which project off the endplates; l5-s 1 small calcified ridge or disc noted posteriorly slightly to the left of midline.This causes mild narrowing of the adjacent ventral subarachnoid space.There is mild narrowing of the right neuroforamen.(b)(6) 2010 the patient underwent x rays of the lumbar spine.Impression: post operative changes lumbar spine.(b)(6) 2010 the patient underwent lumbar myelogram.Impression: status post l5 laminectomy.Status post l5 laminectomy.Status post l3-s1 posterior spinal and interbody fusion.No evidence of abnormal compression of thecal sac or spinal stenosis.(b)(6) 2010 the patient underwent x rays of the lumbar spine.Impression: there is no significant interval change in appearance since the prior exam.(b)(6) 2010 the patient underwent x rays of the chest.Impression: no pneumonia.Faint lucency seen projecting over the medial aspect of the right hemidiaphragm which is likely artifactual if the patient is asymptomatic or not recently post abdominal surgery.(b)(6) 2011 patient presented for a follow-up visit due to parasthesias of his feet.He is walking with difficulty and with pain into his lower extremities.He complains of pain in his lower back.X-rays were taken of his left knee; ap, lateral and skyline views.There were no loose bodies seen.There was no fracture seen and there was slight spurring seen.There was no narrowing of the joint space.(b)(6) 2010 patient presented for a follow-up visit due to pain in his lower back pain and pain down his left leg with numbness.He had persistent numbness and pain.An mri study was done of the lumbar spine with contrast on (b)(6) 2010.A ct scan was done of the lumbar spine on (b)(6) 2010.The study showed status post posterior spinal fusion of l3 through s1 with 4 sets of pedicle screws and 3 interbody spacers.The pedicle screws were intact.X-rays were taken of the lumbosacral spine and showed cage and pedicle screws.These are masses seen laterally on the right side and left side.Lateral view showed no screws in the foraminal spaces and/or in the spinal space.(b)(6) 2010, (b)(6) 2010: patient presented for a follow up visit with complaint of pain in his back.(b)(6) 2010 patient underwent ct lumbar myelogram.Alignment and hardware intact.Solid l3-s1 posterior bony fusion along posterior elements.Status post l3-l4 l5-s1 interbody fusion with bone graft.(b)(6) 2010 patient presented for a follow-up visit due to some neurological condition.(b)(6) 2010: patient presented for a follow up visit with complaint of pain in his back and pain into his left thigh and right buttocks.(b)(6) 2010, (b)(6) 2011, (b)(6) 2012: per billing records, patient presented for office visit.Diagnosis: displacement of lumbar intervertebral disc without myelopathy; thoracic or lumbosacral neuritis or radiculitis, unspecified; abnormality of gait; hereditary progressive muscular dystrophy.(b)(6) 2010 patient underwent chest pa/lat 2v.Impression: no pneumonia, faint lucency seen projecting over medial aspect of right hemidiaphragm which is likely artifactual if the patient is asymptomatic or not recently post abdominal surgery.(b)(6) 2010 patient underwent the following surgeries: removal of hardware, lumbar spine; inspection of fusion mass; revision laminectomy l4 -5 to treat the following pre-op diagnosis: painful hardware lumbar spine with associated stenosis.(b)(6) 2010 patient underwent spine w/o contrast.Impression: status post posterior decompression from the level of l3 to the s1; l5-s1: no central canal stenosis noted.There are posterior facet hypertrophic changes as well as hypertrophic changes surrounding the right pedicle resulting in moderate-to-severe right foramina! stenosis, unchanged from the prior ct scan dated (b)(6) 2010; severe posterior facet hypertrophic change is noted from level of l2-l3 to l4-l5 resulting in mild to moderate foraminal stenosis as described above; edema noted within the soft tissues superficial to the exiting l4 and l5 vertebral bodies in the surgical bed.This is nonspecific in nature and correlation with point tenderness is recommended.(b)(6) 2011 the patient underwent x rays of the lumbar spine.Impression: status post l2-5 laminectomies.Status post removal of posterior hardware from l3-s1.Status post interbody fusion l3-4 to l5-s1.Satisfactory lumbar alignment.(b)(6) 2011 the patient underwent x rays of the left knee.Impression: no evidence of acute cortical fracture or dislocation.The patient also underwent x rays of the lumbar spine.Impression: no significant change.(b)(6) 2011 patient underwent lumbar spine 2v.Impression: no significant change.(b)(6) 2011 patient underwent lumbar spine 2v.Impression: status post l2-l5 laminectomies.Status post removal of posterior hardware from l3-s1.Status post interbody fusion l3-l4 to l5-s1.Satisfactory lumbar alignment.(b)(6) 2011 patient presented for an office visit due to his left knee will buckle.X-rays were taken of his left knee in rays were taken in standing position.The medial joint with spurring of the ap and lateral view.X-rays show narrowing of tibial eminence.(b)(6) 2011: patient presented for a follow up visit with complaint of pain in his lower back and his right hip.(b)(6) 2011: patient presented for a follow up visit with complaint of paresthesias of his feet.(b)(6) 2011 patient underwent mri of lumbar spine.Impression: status post posterior decompression from the level of l3 to the s1; l5-s1: no central canal stenosis noted.There are posterior facet hypertrophic changes as well as hypertrophic changes surrounding the right pedicle resulting in moderate-to-severe right foraminal stenosis, unchanged from the prior ct scan dated (b)(6) 2010; severe posterior facet hypertrophic change is noted from level of l2-l3 to l4-l5 resulting in mild to moderate foraminal stenosis as described above; edema noted within the soft tissues superficial to the exiting l4 and l5 vertebral bodies in the surgical bed.This is nonspecific in nature and correlation with point tenderness is recommended.(b)(6) 2011 the patient was presented for office visit with increasing pain right radiculopathic l5 and s1 pain.(b)(6) 2012 patient presented for a follow-up visit due to back pain.He has pain in his lower back and pain into his buttocks.The pain down his legs has become significant.He was admitted to northern (b)(6) hospital.(b)(6) 2012: patient presented for a follow-up visit due to persistent back pain in his lower back and pain into his legs.(b)(6) 2012 the patient underwent x rays of the lumbar spine.Impression: no significant change.(b)(6) 2012 patient underwent ct lumbar spine w/o contrast.Impression: solid fusion l3-s1.Right foramen narrowing l3-l4, l5-s1 secondary to bone encroachment on the foramina.No disc herniation or spinal stenosis.(b)(6) 2012 patient underwent ct scan thoracic spine.Impression: mild dorsal cord compression t3-t4 related to thickening of the ligamentum flavum.Mild cord compression t5-t6 related to small central disc herniation and thickening of the ligamentum flavum.(b)(6) 2012 patient underwent ct scan of cervical spine.Impression: small central/left disc herniation c3-c4 with mild left-sided cord compression and compression of the left c4 nerve root.Small, central, partially calcified disc herniation c4-c5, c5-c6 and c6-c7 without nerve root or cord compression.(b)(6) 2012 the patient underwent myelogram of the cervical spine, lumbar spine and thoracic spine.Impression: mild dorsal cord com pression t3-t4 related to thickening of the ligamentum flavum.Mild cord compression t5-t6 related to small central disc herniation and thickening of the ligamentum flavum.The patient also underwent ct of cervical spine.Impression: small central/left disc herniation c3-c4 with mild left-sided cord compression and compression of the left c4 nerve root.Small, central, partially calcified disc herniation c4-c5, c5-c6, c6-c7 without nerve root or cord compression.(b)(6) 2012 patient presented for an office visit due to back pain.Impression: status post l3-s1 fusion with decompression a minimal right convexity thoracic scoliosis.(b)(6) 2012 patient underwent x-ray of lumbosacral spine bending view.Impression: no acute osseous abnormality of the lumbosacral spine.(b)(6) 2012 patient presented for a follow-up visit due to pain in his back and pain down his legs.He feels weakness in his left leg.Patient underwent x-rays were taken of his lumbosacral spine ap and lateral views.The cages are in position at l3-l4, l4-l5 and l5-s1.(b)(6) 2012 patient underwent x-ray of spine scoliosis erect views.Impression: minimal convex right scoliosis that improves with rightward bending and increases with leftward bending.Status post laminectomies from l3 to s1 with intervertebral spacers at l3-l4, l4-l5 and l5-s1.(b)(6) 2012: the patient presented for a follow up visit for severe back pain.(b)(6) 2012 patient had persistent pain in his lower back and the pain goes into his extremities.He had paresthesias in his extremities.He felt like his left leg was completely numb.Patient underwent x-rays of lumbosacral spine and showed straightening of the lumbar spine from l1-l5.There are spur formations seen at levels l5-sl, l4-l5, and l3-l4.There is loss or inability to identify the spinal canal as well as the foraminal spaces as seen on lumbosacral spine at l3-s1.L4-l5 and l5-s1.Oblique view as far as the cages are present at level l3-l4, x-rays were taken of his pelvis; ap view.The sacroiliac joints are intact.There is spinal stenosis with hamstring tightness and perhaps foraminal stenosis as evident on x-rays.(b)(6) 2012 patient underwent ct myelogram of his lower back to evaluate for spinal stenosis and/or neural foraminal stenosis.Patient underwent mri of spine with and without contrast on (b)(6) 2010.(b)(6) 2012 patient presented with a ct scan of his lumbar spine on (b)(6) 2012.(b)(6) 2012 patient underwent x-rays of left knee: ap and lateral view.There was no fracture seen about the left knee.(b)(6) 2012 patient underwent ct scan of lumbar spine.Impression: no significant interval change since study (b)(6) 2012, solid anterior and posterior interbody fusion l3-s1.Right foramen narrowing l3-l4, l4-l5 secondary to bony encroachment on the foramina, no disc herniation or spinal stenosis.Mild, stable, degenerative changes at sacroiliac joints.(b)(6) 2012 patient underwent lumbar myelogram.Impression: lumbar myelogram performed without immediate complication.(b)(6) 2012: patient underwent-ray of chest.Impression: no evidence of acute infiltrate.Patient also underwent ecg.(b)(6) 2012: patient presented with pre-operative diagnosis of: history of lumbar decompression and fusion l3-s1; recurrent lower back pain, recurrent lumbar stenosis l4-l5 and l5-s1 and bilateral lumbar radiculopathy, chronic left foot drop and underwent bilateral redo l3-l4 and l5-s1 laminectomy for spinal canal lateral recess decompression, for decompression of bilateral l3-s1 nerve roots, microsurgical dissection with operative microscope and microsurgical technique.Indications: patient with persistent back pain and lumbar radiculopathy has undergone multiple lumbar surgeries, but remained with significant back pain and sciatica.Patient also has left greater than right leg weakness.Emg demonstrated l5-s1 radiculopathy bilaterally, left greater than right.Ct myelogram demonstrated a large residual osteophyte on the right side in the lateral recess extending into the l5-s1 neural foramen with l5 nerve root impingement.Findings: dense paraspinal and epidural fibrosis; extremely sensitive left sided lumbar nerve root left l5-s1; scarred down dura with dural defect centrally and towards the right at l5-s1.There were no patient complications.(b)(6) 2012: post operative day 1: patient does describe significant pain with movement.(b)(6) 2012: patient was discharged.(b)(6) 2012 patient underwent x-rays of lumbar spine and showed cages in the spine to keep the spine open and maintain foraminal spaces.(b)(6) 2013 patient underwent x-rays of left knee in ap, lateral and skyline view.(b)(6) 2013 patient presented due to lower back problems.He underwent x-rays of thoracic spine.(b)(6) 2013 patient underwent mri of the lumbar spine without contrast.Impression: status post posterior laminectomy and decompression from the level of l3 to the level of s1.Postsurgical changes noted with a 6.4 x 2.7 x 2.7 cm postsurgical fluid collection in the surgical bed causing mass effect on the posterior aspect of the thecal sac with resultant mild central canal stenosis at the level of l5; increased soft tissue within the right neural foramen at the level of l5-s1 resulting in moderate-to-severe foraminal stenosis likely related to postsurgical granulation tissue; moderate bilateral foraminal stenosis noted at l4-l5.Moderate right foraminal stenosis at l3-l4.Small left foraminal/extraforaminal protrusion at l2-l3 causing mild to moderate foraminal stenosis; disc bulge with a right paracentral protrusion at ll-l2 flattening the right lateral recess and minimally reaching the descending right l2 nerve root in the canal.Resultant mild central canal stenosis.(b)(6) 2013 patient underwent x-ray of thoracic spine.Impression: no evidence of fracture, vertebral compression or destructive bony lesion.Mild spondylosis deformans.If clinically indicated, further evaluation is recommended.(b)(6) 2013 patient had pain into his back and pain into his left lower extremity.He said his back has become worse in the last 3-4 weeks.He had trouble extending his back and straightening up.(b)(6) 2013 patient presented for a follow-up visit due to lower back pain.The pain also radiates to his right hip and buttock.Impression: lumbar post-laminectomy syndrome; lumbar-thoracic radiculitis.(b)(6) 2013, (b)(6) 2013 patient had trouble with his back.He can¿t get himself straight.(b)(6) 2013 patient indicated that he is not doing well.He had pin in his neck and upper back.He had trouble standing and walking.He is unable to straighten himself out.(b)(6) 2013 patient¿s final diagnosis: epidural fluid, evacuation satisfactory for evaluation no malignant cells identified.Markedly hypocellular specimen with scant lymphocytes, and proteinaceous material present.Impression: status post posterior laminectomy and decompression from the level of l3 to the level of s1.Postsurgical changes noted with a 6.4 x 2.7 x 2.7 cm postsurgical fluid collection in the surgical bed causing mass effect on the posterior aspect of the thecal sac with resultant mild central canal stenosis at the level of l5; increased soft tissue within the right neural foramen at the level of l5-s1 resulting in moderate-to-severe foramina! stenosis likely related to postsurgical granulation tissue; moderate bilateral foramina! stenosis noted at l4-l5.Moderate right foraminal stenosis at l3-l4.Small left foraminal/extraforaminal protrusion at l2-l3 causing mild to moderate foraminal stenosis; disc bulge with a right paracentral protrusion at ll-l2 flattening the right lateral recess and minimally reaching the descending right l2 nerve root in the canal.Resultant mild central canal stenosis.Patient underwent radiological test of lumbar spine during an epidural aspiration procedure.(b)(6) 2013 patient presented for a follow-up visit due to pain in his low back and pain down his left leg.He also had weakness of his right and left leg.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key7641259
MDR Text Key112546750
Report Number1030489-2018-00918
Device Sequence Number1
Product Code NEK
UDI-Device Identifier00681490843829
UDI-Public00681490843829
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Catalogue Number7510800
Device Lot NumberM112001ABD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/26/2012
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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