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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 7510200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Dyspnea (1816); Headache (1880); Incontinence (1928); Nausea (1970); Pain (1994); Swelling (2091); Vomiting (2144); Weakness (2145); Stenosis (2263); Injury (2348); Numbness (2415); Neck Pain (2433); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
(b)(6) 2006 patient presented with lumbar herniated disc, pain across the low back, more severe shooting pain down in his right leg.Impressions: lumbar degenerative disc disease, herniated lumbar disc, hx of lumbar microdiscectomy.Operative procedure:1.Redo right l4-5 hemilaminotomy, foraminotomy, and microdiskectomy.2.Left l4-5 hemilaminotomy, foraminotomy, and microdiskectomy.There were no complications.(b)(6) 2007 patient presented for surgery with preop and postop diagnosis : recurrent herniated l4-5 disk.03/20/07 patient underwent 1.L4-5 extreme lateral interbody fusion with insertion of interbody cage and rh-bmp2/acs.2.Redo right l4-5 microdiscectomy 3.Placement of trans facet screws at l4-5 bilaterally.4.Real time nerve monitoring and free running emg.5.Intraoperative fluoroscopy (b)(6) 2010 patient underwent chest x-ray: no acute process present.Preop and postop diagnosis: recurrent herniated l4-5 disc.Patient sustained an injury at work with a herniated l4-5 disc.He suffered a recurrent herniated disc and yet another recurrent herniated disc because he had a predominance of leg pain.A fusion was not initially suggested but because of yet another recurrent herniation, a discectomy with fusion was recommended.As per op notes the patient was implanted using rhbmp-2/acs, miscellaneous implants and 4.5mm x 30mmcannulated fact screw.Probe with neuro vision for real-time nerve monitoring a trajectory was identified after careful checking and monitoring of the nerves that caused no neural irritation and allowed for docking in the disc space.Endplates were completely prepared for the interbody cage.Two sponges that had been soaked for an hour with rh-bmp2/acs were placed into the cage and secured with a #1 vicryl tie.The endplates were again inspected and the cage was impacted into posi tion with ap and lateral fluoroscopy demonstrating both excellent restoration of disc space height and excellent position of the cage in both projections.At this point, the retractor was removed and additional ap and lateral images were obtained.There were no co mplications.(b)(6) 2007 the patient was discharged.Admitted on (b)(6) 2010 discharged on (b)(6) 2010 patient presented for chest congestion and cough that have worsened over the past two days.Patient had difficulty in catching his breath, almost hyperventilating, was light headed and had some heaviness in his chest.He took off because of cold and nasal congestion for past three months.Patient had trouble with season changes and colds his whole life but never been diagnosed with asthma.Patient denies any nausea, vomiting, headache, body ache, fever.Patient does admit to congestion, cough will clear sputum, chest discomfort with coughing.Patient was admitted for reactive airway disease exacerbation with bronchitis.He was breathing better and discharged to follow-up i 2 days in fmc with primary.(b)(6) 2011 patient presented with pmh of asthma.Bipolar disorder and h/o anterior cervical discectomy and fusion for cervical spine injury in2005 (had residual neurological deficits after first surgery) and 4 lumbar surgeries in 2008 who presented to cch ed with cc of 3 week progressive worsening low back pain and ue and le numbness (started in toes and fingertips, progressed to the level of the elbows in ue and above the knees in le).In addition, reports 2 episodes of losing control over bowel movements and worsening sexual disfunction (able to maintain erection.But for relatively short time).Mri lumbar: multilevel degenerative disc disease and degenerative facet arthropathy.Status post l4/l5 diskectomy and bilateral l5 transpedicular screws placement changes.Impression: pt with h/o spine djd.Anterior cervical discectomy and fusion in 2005 and multiple lumbar discectomy surgeries in 2008 presenting with ue and le decreased l t and pinprick sensation, hyperreflexia and some le weakness.In addition, he has decreased rectal tone and transitory bowel incontinence.Overall clinical presentation s/w cervical myelopathy 2/2 djd.(b)(6) 2011 patient presented with primary discharge diagnoses: - c3-c4 herniated disc and general cervical stenosis.Secondary diagnoses: bipolar disorder, asthma, acdf of cervical spine 2003, lumbar djd with disc herniation sp surgical repair times 4 - last in 2008.Patient complaining of 4 week progressive numbness first starting on toes, fingers, than progressing to hands/feet, arms/legs.Patient also has h/o bowel incontinence - 2 episodes.More urgency than incontinence- also noticed more difficulty to urinate.Imbalance.Cervical mri showed c3-c4 herniated disc and general cervical stenosis.04/11/11 patient presented for neurosurgery having neck and shoulder pain.Bil ue weakness.Spine fusion acdf in 2003 and 4 different lumbar surgeries including a fusion.The pt comes in with 1 month of worsening neck and bil shoulder pain.About 3 weeks ago he started to feel his hands (right>left) becoming weak and he started to drop things.Over that same time period he has had issues holding his bowel movements (urgency) and at times feeling constipated.He also has had urinary retention issues all over this same time period.The pt.Does have some mild low back pain that does not radiate to the legs, but the neck/shoulder pain is much worse.Patient underwent mri for diffuse cervical disease.Multiple levels of stenosis, the worst at c3/4 with cord compression and cord signal change.04/12/11 patient presented for preop note: pt.Today is undergoing cervical laminectomy with fusion.The pt.Preop has cervical stenosis with bil hand grip weakness and severe shoulder and arm pain.The procedure was explained to the pt.Along with the benefits and risks.This included but not limited to bleeding, infection, worsened neurologic function, csf leak, bowel/bladder dysfunction, stroke, coma, death, need for additional surgery.Operative report: preop and postop: cervical stenosis.Procedure performed: c3 through c7 laminectomy and c2 through tl posterior cervical fusion.Implant used: stryke oasis system.(b)(6) 2011 patient presented with primary discharge diagnoses: cervical myelopathy.Secondary diagnoses: cervical laminectomies (c3-c7); posterior cervical fusion c2-t1.Patient presented to ed complaining of one month of worsening of his numbness feelings inb/l arms, in tunck, legs and feet.On exam.The patient was found to be myelopathic.Mri (b)(6) 2011 was read by radiology attending as cervical spondylitic changes and multilevel degenerative disc disease with spinal canal and bilateral neuroforamina stenosis.Post acdf changes atc5 through c7.High t2/stir signal intensity within the cervical spinal cord at the level of c3/c4, reflects myelomalacia.Pt underwent c3 through c7 laminectomy and c2 through t1 posterior cervical fusion.Pt has been seen and followed by pt who clreared him for discharge on pod# 3; also pt seen by pain service.(b)(6) 2013 patient presented with pain for mri - l3/l4: circumferential disc bulge effacing ventral epidural fat <(>&<)> abuts bilateral proximal l4 traversing nerve roots <(>&<)> narrows inferior neuroforamina.L4/l5: circumferential disc bulge effacing ventral epi dural fat and abuts bilateral proximal l5 traversing nerve roots and narrows inferior neuroforamina.L5/s1: circumferential disc bulge effacing ventral epidural fat and narrows inferior neuroforamina.Patient presented for follow up for neurological: alert and oriented to person, place, time, and situation, speech: normal.Musculoskeletal: back: midline scar+ in upper back and lower back, well healed no swelling.Spurlings negative.No trigger points or paraspinal tenderness.Soft tissue examination tender to palpation with lower paraspinal muscles with spasm joints examination tender bilateral sij and l3-4 spinous process, hip.In jul 2013 patented had undergone x ray of ls spine.(b)(6) 2013 patient presented for follow-up with arm pain-swelling.Chest pain-non pleur radiating to his right hand.Associated symptoms: tingling and numbness.Patient admitted to tingling of the left 3rd, 4th, 5th fingers radiating to the medial left elbow region extending in the axilla region.Patient admits to the pain being so severe that "it takes my breath away".Patient notes to reproducible pain in the left axillar /upper chest region.Patient denies any dizziness, pnd, orthopnea or cough like usual asthma attack.Musculoskeletal: normal rom, normal strength, no tenderness, no swelling, proximal upper extremity: left, tenderness, range of motion normal, noted at the left axilla region, no swelling, no erythema, no ecchymosis, distal upper extremity: left, range of motion normal, no swelling, no abrasion, no erythema, no ecchymosis, hand: left, range of motion normal, no tenderness, no swelling, fingers/toes: left, third, fourth, fifth, finger(s), range of motion normal, decreased sensation to touch/bilateral readial pulse +2=b, no tenderness, no swelling, no abrasion, no erythema, no ecchymosis.Neurological: alert and oriented to person, place, time, and situation.Psychiatric: cooperative, appropriate mood <(>&<)> affect, normal judgment, non-suicidal.Patient presented with indication: radiculopathy technique: ct cervical spine without iv contrast comparison: ct cervical spine without iv contrast dated 04/11/2011 findings/ impression: alignment is normal.No evidence of acute fracture or dislocation.Surgical hardware is intact.There is interval progression of degenerative disc and uncovertebral joint disease with multilevel neuroforaminal narrowing.No significant spinal canal narrowing.(b)(6) 2013 patient presented for follow-up mri of lower thoracic and lumbar spine without and with iv contrast.Findings: there is mild straightening of normal lumbar lordosis with anatomic alignment of the vertebrae.Partial desiccation of the intervertebral discs at the levels of l1/l2 through l5/s1 associated with degenerative changes involving the vertebral plates, greatest at l4/l5.Diffuse low t1 signal intensity involving the vertebrae, suggesting physiologic red marrow reconversion.Clinical correlation recommended.The distal thoracic spinal cord is intact, with the conus medullaris at the level of t12/l1.(b)(6) 2013 patient presented for follow-up with neck and low back pain and had more pain in ue and pain is radiating to bilateral forearm and hands also feels his right hand is feeling weak and drop things sometimes.Patient presented for mri of lower thoracic and lumbar spine.Findings: there is mild straightening of normal lumbar lordosis with anatomic alignment of the vertebrae.Partial desiccation of the intervertebral discs at the levels of l1/l2 through l5/s1 associated with degenerative changes involving the vertebral plates, greatest at l4/l5.Diffuse low t1 signal intensity involving the vertebrae, suggesting physiologic red marrow reconversion.Clinical correlation recommended.The distal thoracic spinal cord is intact, with the conus medullaris at the level of t12/l1.Additional specific findings at different levels are as follows: l1/l2: diffuse posterior disc bulge with partial posterior annular fissure effacing ventral thecal sac and abuts the cauda equina roots.The minimum ap diameter of the central spinal canal measures 14.1 mm.L2/l3: circumferential disc bulge effacing thecal sac and abuts bilateral proximal l3 traversing nerve roots and narrows inferior neural foramina.The minimum ap diameter of the centralcanal canal measures 16.6 mm.L3/l4: circumferential disc bulge effacing ventral epidural fat and abuts bilateral proximal 14 traversing nerve roots and narrows inferior neuroforamina.The minimum ap diameter of the central spinal canal measures 12.2 mm.14/15: old post diskectomy and bilateral 15 transpedicular screws placement changes are noted.Circumferential disc bulge effacing ventral epidural fat and abuts bilateral proximal 15 traversing nerve roots and narrows inferior neuroforamina.The minimum ap diameter of the central spinal canal measures 14.9 mm.Moderate degenerative changes involving bilateral facet joints.15/s1: circumferential disc bulge effacing ventral epidural fat and narrows inferior neuroforamina.No spinal canal stenosis.Mild degenerative changes involving bilateral facet joints.Impression: multilevel degenerative disc disease and degenerative facet arthropathy as described above.Status post 14/15 diskectomy and bilateral 15 transpedicular screws placement changes.Ct of lumbar spine correlation recommended for evaluation of the surgical screws if clinically indicated.Mri c spine: cervical spine: history: neck pain with bilateral upper and lower extremities weakness.Findings: there is straightening of normal cervical lordosis with anatomic alignment of the vertebrae.Anterior marginal osteophytes arising from the anteroinferior vertebral end plates of c3 and c4.Desiccation of c3/c4 intervertebral disc associated with mixed modic type 1 and iii degenerative changes inv olving the vertebral endplates.Post acdf changes are notedat c5 through c7.The cerebellar tonsils are normal in position.There is high t2/stir signal in the cervical spinal cord at the level of c3/c4, reflects myelomalacia.The rest specific findings at different levels are as follows: c2/c3: mild diffuse posterior disc bulge partially effacing thecal sac.The minimum ap diameter of the central spinal canal measures 9.1 mm, reflects mild stenosis.Patent neuroforamina.C3/c4: circumferential disc bulge with posterocentral disc protrusion deforming ventral spinal cord and narrows bilateral neuroforamina.The minimum ap diameter of the central spinal canal measures 5.6 mm, reflects stenosis.C4/c5: circumferential disc bulge effacing ventral thecal sac and narrows bilateral neural foramina.The minimum ap diameter of the central spinal canal measures 7.1 mm reflects stenosis.C5/c6 and c6/c7: post acdf changes.C7/tl: diffuse posterior disc bulge with posterocentral disc protrusion effacing ventral thecal sac.The m1n1mum ap diameter of the central spinal canal measures 8.4 mm reflects stenosis.Impression: cervical spondylitic changes and multilevel degenerative disc disease with spinal canal and bilateral neuroforamina stenosis, as described above.Post acdf changes at c5 through c7.High t2/stir signal intensity within the cervical spinal cord at the level of c3/c4 reflects myelomalacia.(b)(6) 2013 patient presented for follow-up with radiculopathy using ct cervical spine.(b)(6) 2013 patient presented for follow-up with ct cervical spine.Findings/ impression: alignment is normal.No evidence of acute fracture ordislocation.Surgical hardware is intact.There is interval progression of degenerative disc and uncovertebral joint disease with multilevel neuroforaminal narrowing.No significant spinal canal narrowing.(b)(6) 2013 patient presented for follow-up with chronic cervical radiculopathy and lumbar radiculopathy.He is more weak and stiff in his hand.Neck: mild tenderness to palpation of the cervical paraspinous muscles, no spasm noted.Arms: claw deformity of the left hand, wasting of the musculature of bilateral hands, still able to close his hands.Decreased strength.Neuro: pt alert and oriented.Cn 2-12 intact sensation intact bilaterally dtr's: +2 bilaterally.Findings: ct cervical spine post myelogram with coronal and sagittal reconstructions: comparison: mri cervical spine complete on 4-8-11.Findings: straightening of cervical spine with loss of normal lordotic curvature.Base of skull-cl: myelographic contrast seen within posterior fossa cisterns and fourth ventricle.Cl-c2: bilateral c2 lateral mass screws with head hooks attached to respect ipsilateral vertical rod.Slight bilateral uncinate process and facet hypertrophic changes.C2-c3: bilateral c2 and c3 lateral mass screws with head hooks attached to respect ipsilateral vertical rod.Facet joints fused.Slight bilateral uncinate process and facet hypertrophic changes.C3-c4: bilateral c3 and c4 lateral mass screws with head hook attached to respect ipsilateral vertical rod.Facet joints fused.Slight bilateral uncinate process and facet hypertrophic changes.Moderate loss of disc height.Moderate size c4 anterior endplate osteophyte projecting inferoanteriorly.C4-c5: bilateral c4 and c5 lateral mass screws with head hooks attached to respect ipsilateral vertical rod.Mild loss of disc height.Facet joints fused.Mild bilateral uncinate process and facet hypertrophic changes.Moderate size c4 anterior endplate osteophyte projecting inferoanteriorly.Two screws seen coursing through anterior c5 to c7 anterior vertical plate and into c5 vertebral body.C5-c6: two screws seen coursing through anterior c5 to c7 anterior vertical plate and into c5 vertebral body.Two screws seen coursing through anterior c5 to c7 anterior vertical plate and into c6 vertebral body.Dense bony fusion of c5-c6 disc space.Mild bilateral uncinate process and facet hypertrophic changes.Bilateral c5 and c6 lateral mass screws with head hooks attached to respective ipsilateral vertical rod.C6-c7: two screws seen coursing through anterior c5 to c7 vertical plate and into c6 vertebral body.Two screws seen coursing through anterior c5 to c7 anterior vertical plate and into c7 vertebral body.Dense bony fusion of c6-c7 disc space.Mild bilateral uncinate process and facet hypertrophic changes.Bilateral c6 lateral mass screws with head hooks attached to respective ipsilateral vertical rod.C7-tl: two screws seen coursing through anterior c5 to c7 anterior vertical plate and into c7 vertebral body.Bilateral tl pedicle screws with head hooks attached to respective ipsilateral vertical rod.Tl-t2: bilateral tl transpedicular screws with head hooks attached to respective ipsilateral vertical rod.Marked loss of disc.Circumferential broad-based mild-moderate disc bulge resulting in mild effacement of anterior thecal sac wall.Thin myelographic ring surrounding cord.(b)(6) 2013 patient visited office for neurosurgery having hand numbness, tingling and weakness, of the upper extremity.He also experienced a shooting pain down his left shoulder that appears intermittently in the c5 distribution.(b)(6) 2013 patient presented for follow-up with difficulty breathing and pt with hx of asthma, bipolar presenting for sob.He was using his inhalers.No fever, no chills, no nn, never been intubated.No cough, mild nasal congestion.He reported that he had seasonal allergies its t tipped his asthma now.No drugs, no heroin.No other complaints.No sl, no hi.Musculoskeletal symptoms and neurologic symptoms: negative except as documented in hpi.(b)(6) 2013 patient presented for postop follow-up with post lumbosacral myelogram ct with coronal \t\ sagittal reconstructions.Findings: t10-t11: unremarkable.T11-t-12: unremarkable.T12-l1: conus terminates in the level of midbody l1.L1-l2: minimal circumferential broad-based disc bulge.L2-l3: mild circumferential broad-based disc bulge resulting in mild effacement of the anterior thecal sac wall.Slight ligamentum flavum and facet hypertrophy.Minimal l2 anterior endplate productive changes.Small left anterolateral l3 superior endplate region osteophyte projecting superolaterally.Opacified thecal sac assumes a slight "hourglass" configuration.L3-l4: moderate circumferential broad-based disc bulge with mild-moderate lateral protrusion into respective neural foramina.Moderate ligamentum flavum hypertrophy.Approximately 20 x 12 x 6 mm, lenticular shaped, left anterior epidural soft tissue density arising from the posterior margin of the l3-l4 disk space to protrude inferiorly.This epidural soft tissue mass result in mild-moderate ef facement of the adjacent left anterior thecal sac wall with crowding of the nerve roots.Opacified thecal sac assumes a mild-moderate "hourglass" configuration.Fragmented mild-moderate size anterior bridging osteophyte.L4-l5: bony fusion of the disc space.Six 11 x 2.5 mm metallic density foreign bodies seen vertically arranged within the bony fused disc space.Slight clumping of nerve roots.Bilateral facet screws demonstrated.Fused facet joints.Mild bilateral facet periarticular productive changes.Partial laminectomy changes.L5-s1: loss of disc height.Gas seen within disc space.Mild circumferential broad-based disc bulge.Multiple small endplate cystic changes.Endplate sclerotic changes.Slightend plate productive changes.S1-coccyx: unremarkable.Impression: 1.Mild-moderate l2-l3 central canal stenosis secondary to moderate circumferential disc bulge, slight ligamentum flavum hypertrophy and slight facet hypertrophy.2.Moderate l3-l4 central canal stenosis secondary to moderate circumferential disc bulge, mild-moderate ligamentum flavum hypertrophy and mild facet hypertrophic changes associated with left disc extrusion and/or scar tissue along the left posterior wall of l4 vertebral body.Extruded disc and/or scar tissue fragment effaces the left anterolateral wall of the thecal sac at this level.3.Status post l4-l5 partial laminectomy changes, bilateral facet fusion with respective screws, and l4-l5 discectomy with disc space fusion using this prosthesis.4.No evidence of spondylolisthesis.5.Likely status post l5-s1 discectomy and/or dege nerative and/or chronic discitis changes.Mild l5-s1 circumferential broad-based disc bulge.(b)(6) 2013 ct - l3/l4: moderate circumferential broad-based disc bulge with mild-moderate lateral protrusion into respective neural foramina.Moderate ligamentum flavum hypertrophy.Left anterior epidural soft tissue density arising from posterior margin of l3-l4 disc space to protrude inferiorly.This epidural soft tissue mass result in mild-moderate effacement of the adjacent left anterior thecal sac wall with crowding of the nerve roots.Opacified thecal sac assumes a mild-moderate hourglass configuration.Fragmented mild-moderate size anterior bridging osteophyte.L5-s1: mild circumferential broad-based disc bulge.Endplate cystic and sclerotic changes.Patient presented for cervical radiculopathy bilateral c8-t1 distribution.Findings: straightening of cervical spine with loss of normal lordotic curvature.Base of skull-cl: myelographic contrast seen within posterior fossa cisterns and fourth ventricle.Cl-c2: bilateral c2 lateral mass screws with head hooks attached to respect ipsilateral vertical rod.Slight bilateral uncinate process and facet hypertrophic changes.C2-c3: bilateral c2 and c3 lateral mass screws with head hooks attached to respect ipsilateral vertical rod.Facet joints fused.Slight bilateral uncinated process and facet hypertrophic changes.C3-c4: bilateral c3 and c4 lateral mass screws with head hook attached to respect ipsilateral vertical rod.Facet joints fused.Slight bilateral uncinate process and facet hypertrophic changes.Moderate loss of disc height.Moderate size c4 anterior endplate osteophyte projecting inferoanteri orly.C4-c5: bilateral c4 and cs lateral mass screws with head hooks attached to respect ipsilateral vertical rod.Mild loss of disc height.Facet joints fused.Mild bilateral uncinate process and facet hypertrophic changes.Moderate size c4 anterior endplate oste ophyte projecting inferoanteriorly.Two screws seen coursing through anterior cs to c7 anterior vertical plate and into cs vertebral body.C5-c6: two screws seen coursing through anterior cs to c7 anterior vertical plate and into c5 vertebral body.Two screws seen coursing through anterior cs to c7 anterior vertical plate and into c6 vertebral body.Dense bony fusion of c5-c6 disc space.Mild bilateral uncinate process and facet hypertrophic changes.Bilateral cs and c6 lateral mass screws with head hooks attached to respective ipsilateral vertical rod.C6-c7: two screws seen coursing through anterior cs to c7 vertical plate and into c6 vertebral body.Two screws seen coursing through anterior cs to c7 anterior vertical plate and into c7 vertebral body.Dense bony fusion of c6-c7 disc space.Mild bilateral uncinate process and facet hypertrophic changes.Bilateral c6 lateral mass screws with head hooks attached to respective ipsilateral vertical rod.C7-tl: two screws seen coursing through anterior cs to c7 anterior vertical plate and into c7 vertebral body.Bilateral tl pedicle screws with head hooks attached to respective ipsilateral vertical rod.T1-t2: bilateral t1 transpedicular screws with head hooks attached to respective ipsilateral vertical rod.Marked loss of disc.Circumferential broad- based mild-moderate disc bulge resulting in mild effacement of anterior thecal sac wall.Thin myelographic ring surrounding cord.11/22/13 presented for postop follow-up for mri cervical spine, findings: study is limited secondary to artifact from metallic posts urgical changes as described below, particularly when evaluating spinal canal or neuroforaminal narrowing.Cervical vertebral bodies: status post acdf changes are noted at c5-c7.There is ankylosis of the c5-c7 vertebral bodies with complete loss of intervertebral disc space.Status postlaminectomy changes are noted at c3-c7 and posterior fusion changes at c2-tl.Intervertebral disc spaces: there is multilevel disk desiccation.Cervical cord: no signal abnormality.There are no abnormal areas of postcontrast enhancement.Impression: markedly limited study in the evaluation of neural foraminal narrowing secondary to postsurgical changes as described.Status post acdf changes at c5-c7.Status postlaminectomy changes are noted at c3-c7 and posterior fusion changes at c2-t1.Mild multilevel degenerative disc disease as described, most significant for tl-t2 disc bulge with moderate spinal canal narrowing and moderate bilateral neural foraminal narrowing.A mild posterior disc bulge at t2-t3.Clinical correlation is suggested.12/20/13 patient presented for postop follow-up with chronic neck and hand pain.Neck: mild tenderness to palpation of the cervical paraspinous muscles, no spasm noted limited flexion/extension/rotation/lateral flexion.Neuro: pt alert and oriented.Cn 2-12 intact.Decreased sensation over the ulnar distribution of the left hand as well as the posterior hand.Dtr's: +2 bilaterally (b)(6) 2014 patient presented for postop follow-up with myelopathy and neurogenic claudication.The patient continued to have difficulty with strength in his hands as well as gait instability and pain radiating down both his legs and signs consistent with myelopathy as well as neurogenic claudication.Patient sts he didn't get better at all after surgery, noticed he his spasms in his ue and le became more often pain in lbp and back of the back of legs worse.Sts he had bright red stool on and off 2 mos this morning it's a lot also reports he had hemmorhoids.Patient walked unstable, wide based with aid of 2 canes neck: pain and decreased lateral rotation.
 
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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
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5044362
MDR Text Key24654835
Report Number1030489-2015-02143
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Report Date 08/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/01/2009
Device Catalogue Number7510200
Device Lot NumberM110604AAE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/01/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/21/2006
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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