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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Nausea (1970); Neuropathy (1983); Swelling (2091); Weakness (2145); Cramp(s) (2193); Dizziness (2194); Stenosis (2263); Inadequate Pain Relief (2388); Neck Pain (2433); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.
 
Event Description
It was reported that on: (b)(6) 2007: patient presented for follow up visit for complaint of low back pain and right lower extremity paresthesias.(b)(6) 2007: patient presented for an office visit due to low back pain with right lower extremity paresthesias involving the lateral thigh and calf area.Patient had lumbar mri scan which reveals some disc degeneration at multiple levels; which is mild to moderate.At l3-4, there is a grade i spondylolisthesis with diffuse disc bulging.From l3-4 to l5-s1 there is minimal facet arthropathy.There is some lateral recess stenosis at l3-4 and l4-5.At l5-s1, there is a central disc protrusion with some contact of the transiting s1 root.Her symptoms are increased with prolonged standing, walking, bending forward.Physical examination: range of motion is limited with both forward flexion and extension secondary to pain.Impression: low back pain and right lower extremity pain and paresthesias, possibly related to lumbar radiculitis.(b)(6) 2007: patient underwent mri of lumbar spine due to low back, hip and leg pain.Mri of the lumbar spine shows multilevel spondylosis which is generally mild to moderate.The most likely progressive site, however, is: l5 s1: there is moderate to severe left-sided exit foraminal stenosis with potential involvement of the exit left 5th root.(b)(6) 2007: patient presented for follow-up for complaints of low back and low extremity pain.(b)(6) 2007: patient presented for complaint of lbp.Patient received muscle stimulator unit which provided her significant relief and is aiding with maintaining her lumbar paraspinal tone and strength.(b)(6) 2008: patient presented for an office visit for complaints of low back pain, and she has had several injections now without improvement.She is known to suffer from significant facet arthropathy.This has been primarily at l5-s 1 and to a lesser degree at l3-4.She has a slight spondylolisthesis noted at each level.There is significant exit foraminal stenosis and bilateral recess stenosis at the ls-s i level and to a lesser degree at l3-4.Her pain is increased with prolonged standing or walking.(b)(6) 2008: patient presented for complaint of lbp.She is known to suffer from significant facet arthropathy.This has been primarily at l5-s1 and to a lesser degree at l3 4.She has a slight spondylolisthesis noted at each level.There is significant exit foraminal stenosis and bilateral recess stenosis at the l5 s1 level and to a lesser degree at l3-4.Her pain is increased with prolonged standing or walking.(b)(6) 2008: as per x-ray report a slight spondylolisthesis is noted at l3-4.(b)(6) 2009: as per recent mri scan" she has severe degenerative changes particularly in the facets at l5-s1 with bilateral foraminal narrowing consistent with foraminal stenosis.Her pain is axial and non-radicular.She does have pain when she ambulates but again she feels that most of her pain is in the low back not radiating particularly down the hips.More recently she has pain in the right leg.This does radiate down the hip and leg and seems to be a fifth root type distribution.(b)(6) 2009: patient presented for follow up for complaints of low back pain.(b)(6) 2009: the patient presented with lumbar spondylosis and underwent left and right l5/s1 facet injection.No patient complications were reported.(b)(6) 2010: patient underwent cervical mri without contrast due to cervical radiculopathy.Findings: alignment and bony structures; c2-3 through c5-6 mild type i moderate changes.Mid cervical straightening.Spinal cord: normal signal and caliber.Craniocervical junction: unremarkable central elements and junction as visualized, findings by level.C2-3: moderate left uncovertebral hypertrophy, moderate left exit stenosis, crowding exiting left c3.Mild anterior cord flattening.C4-5: disc osteophyte complex is shallow.Left greater than right uncovertebral and facet hypertrophy, moderate right and severe left exit stenosis.Moderate central stenosis.Mild left hemicord flattening.There may be effect on left greater than right exiting c4s, c4-5: shallow disc-osteophyte complex more prominent paracentrally.Uncovertebral and facet hypertrophy.Moderate exit and central stenosis.Mild anterior cord flattening.There may be effect on exiting c5s.C5-6: disc osteophyte complex with left paracentral focal extrusion component, aggregate vertical height 8 mm.Uncovertebral and facet hypertrophy.Moderate exit and severe central stenosis.Moderate left hemicord flattening.There may be effect on left greater than right exiting c6s.C6-7: disc osteophyte complex, uncovertebral and facet hypertrophy.Mild exit narrowing.C7-t1: facet hypertrophy.Mild exit narrowing.(b)(6) 2010: the patient presented for an office visit due to neck pain.Patient underwent mri of cervical spine on (b)(6) 2010.Patient reports significant relief following injections.Patient is complaining of pain located in the left side of the neck that radiates to the left shoulder and numbness in the fingers.Patient rates her pain a 3/10 today on pain scale.Patient is currently taking ryzolt.Assessments: cervical radiculopathy.After reading and reviewing the mri results of the cervical spine patient was referred to another doctor for surgical evaluation for severe spinal stenosis.(b)(6) 2010: patient presented for surgical evaluation for sever spinal stenosis.Mri reveals that the patient has multilevel cervical disc disease.According to surgeon, c5-6 is the most symptomatic level currently, especially with the focal left-sided radiculopathy.(b)(6) 2010: patient underwent x-rays of cervical spine due to neck pain which revealed no acute osseous injury, no spondylolisthesis with flexion or extension, mild degenerative changes, osteopenia.(b)(6) 2010: patient underwent motor nerve test which revealed borderline left median sensory nerve likely residual from old ctr.2.Needle emg revealed chronic denervation changes in left c7 -c6 muscles.Per office notes: "she has significant neck and radicular arm pain.Her cervical plain films show no instability.The emg/nerve conduction studies show some residual left hand carpal tunnel, changes in the left median nerve, as well as some chronic denervation of the left c7 and c6 muscles." (b)(6) 2010: patient underwent following examination: chest ap/pa due to cervical spine stenosis.Preoperative for anterior cervical discectomy and fusion.Impression: no acute pulmonary disease.(b)(6) 2010: patient presented with history of progressive neck and radicular left arm pain and was found to have cervical disk herniation at c5-6 with severe stenosis.The patient has some sensory loss on the c7 dermatome on the left.She has radiculopathy into the c6 dermatome.Patient underwent anterior cervical diskectomy and fusion with plate c5-6 using allograft.Per op notes patient was implanted with rhbmp-2/acs.No patient complications were reported.Operative findings: significant disk disease and disk herniation with neural foramen narrowing.Successful decompression and instrumentation.(b)(6) 2010: patient underwent-rays of cervical spine due to follow up on acdf.Results consistent with recent acdf at c5-c6.(b)(6) 2010: per office notes, patient is having neck pain from facet distraction and some left shoulder stiffness.There is the expected nodularity from the subcutaneous sutures.(b)(6) 2010: per office notes "patient had subsidence of the c6 vertebral body with settling of the bone graft.She is back now with persistent neck and radicular arm rain consistent with her previous complaints, she has difficulty raising her arm and is suffering with increasing radiculopathy.She is, also, tender to palpation ill that region" (b)(6) 2010: patient underwent following examination: spine cervical ap <(>&<)> lat due to pain in left arm which revealed no significant change in appearance of bones and alignment.(b)(6) 2010: patient was admitted and had significant subsidence of her construct and recurrence of pain.The patient has some neuropathic pain in the left arm and mechanical neck pain but otherwise good strength.Review of systems: arthritis, depression, dizziness, walking problems, joint problems.Patient underwent mri of cervical spine w/wo contrast due to neck pain.Impression: 1.No discrete compressive disc herniation any level.However findings suggest mild central canal stenosis with flattening of the cord c2-3 through c5-6 secondary to post hypertrophic spurring and minimal disc bulges.There is also neural foramen narrowing at these levels left side greater than right.2.No enhancement of isc spaces, vertebral bodies or the cervical cord.Cervical alignment remains normal.(b)(6) 2011: the patient presented for an office visit due to neck pain and headache.Patient had neck surgery in (b)(6) with dr.(b)(6).She continues to have neck pain that radiates into the bilateral arms and hands with the left side worse.Patient rates her pain today 9/10 on a pain scale.Assessment: postlaminectomy syndrome, cervical region.(b)(6) 2011: the patient presented for an office visit due to neck pain and to receive a cervical epidural steroid injection.Patient rates her pain today 9/10 on a pain scale.Acd noted at c5-6.Assessment: cervical radiculopathy.(b)(6) 2011: per office notes "recurrence of pain occurred after initial anterior cervical discectomy and fusion in (b)(6).She has significant disease above and below the operative level.Follow-up imaging has shown some subsidence at this level.(b)(6) 2011: the patient presented for an office visit due to neck pain.Patient states she received 90-95% pain relief on the last injection.Patient rates her pain today 2/10 on a pain scale.C5-6 acdf noted on lateral image.Assessment: cervical radiculopathy, unspecified myalgia and myositis.(b)(6) 2011:the patient presented for an office visit due to neck pain.Patient states she received an overall 90% pain relief on the injection treatments.Patient states she has minimal discomfort in her neck that is tolerable however states she is now having low back pain worse on the right.Patient states interment pain in the right thigh.Patient continues to have constipation with taking the opana er.Patient states she takes colace and senokot to help with constipation.Assessment: 1.Post laminectomy syndrome, cervical region; 2.Cervical radiculopathy 3.Thoracic or lumbosacral neuritis or radiculitis, unspecified 4.Unspecified constipation (b)(6) 2011: patient presented for an office visit due to low back pain and neck pain.Review of systems: patient complaining of fatigue, joint pain, joint stiffness.Patient complaining of arm weakness, headache, leg weakness, tingling, numbness.Assessment: post-laminectomy syndrome, cervical region (primary) 2.Cervical radiculopathy 3.Thoracic or lumbosacral neuritis or radiculitis, unspecified.Urine drug screen administered in office, instant results were positive for oxy.Urine sent to lab for further screening.As per lab reports, patient tested positive for oxymorphone.(b)(6) 2011: patient presented for an office visit due to neck and low back pain and medical follow-up.Assessment: postlaminectomy syndrome, cervical region 2.Thoracic or lumbosacral neuritis or radiculitis, unspecified 3.Encounter for long-term (current) use of other medications 4 facet syndrome 5.Degeneration of cervical intervertebral disc.(b)(6) 2011: patient presented for an office visit due to neck pain.Patient complains of return of neck pain.Assessments: 1.Degeneration of cervical intervertebral disc 2.Facet syndrome 3.Cervical spondylosis without myelopathy.Patient underwent cervical medial branch block procedure at left c4-c5.(b)(6) 2011: patient presented for an office visit due to neck pain and confirmatory cmbb.(b)(6) 2011: the patient presented for an office visit due to neck pain and for crfa (cervical radiofrequency ablation) at left c4, c5.Assessments: 1.Degeneration of cervical intervertebral disc 2.Facet syndrome 3.Cervical spondylosis without myelopathy.(b)(6) 2011: patient presented for an office visit due to neck pain and low back pain.Patient states that she has some tenderness in the back of her head today and rates her pain level today 2/10 on a pain scale.Assessments: 1.Postlarninectomy syndrome, cervical region 2.Encounter for long-term (current) use of other medications 3.Degeneration of cervical intervertebral disc 4.Facet syndrome (b)(6) 2011: the patient called and stated that opana is making her sick and she has stopped taking it.She states she has the realize gastric band and many medicines are hard on her stomach.Nucynta tablet was started.(b)(6) 2011: patient called and complained of having issues with her medicine and she didn't want to take nucynta.Patient was informed that nucynta was a narcotic with main side effects being drowsiness and constipation.Most of patients didn't get any mental impairments and are able to function well on this medication.Patient was still leery and wanted to discuss the medication.(b)(6) 2011: patient presented for an office visit due to neck pain, low back pain and medication follow-up.Patient states she is unable to take the opana er and opana ir for severe constipation and causing nausea.She did not want to take the nucynta after reading about the side effects.She would like to stop all narcotics and try injections instead.Assessments 1.Cervical radiculopathy 2.Thoracic or lumbosacral neuritis or radiculitis, unspecified 3.Postlaminectomy syndrome, cervical region.(b)(6) 2011: patient presented for office visit due to low back pain.The patient is complaining of pain located in the low back.The pain radiates to down into the right leg (occasionally) in the right knee.The timing of the pain is continuous, worse during the day.The pain is aggravated by walking.Assessment: thoracic or lumbosacral neuritis or radiculitis, unspecified.The patient received lesi at interlaminar l5-s1.(b)(6) 2011: patient called and brought a disc of mri of her neck.(b)(6) 2011: patient presented for an office visit due to low back pain.Assessments: 1.Post laminectomy syndrome, cervical region 2.Facet syndrome.Patient was recommended hpb back brace to support weak spinal muscles.(b)(6) 2011: patient presented for an office visit due to back pain and underwent lraf at left l3-4, l4-5, l5-s1 (left l2, left l3, l4 nerves and dorsal primary ramus of l5).Assessments: 1.Degeneration of lumbar or lumbosacral intervertebral disc 2.Facet syndrome 3.Spondylosis with myelopathy, lumbar region.4.Osteoarthrosis, unspecified whether generalized or localized, unspecified site.Patient was referred to chiropractor for acupuncture.(b)(6) 2011: patient presented for an office visit due to neck pain and low back pain.She bent over 1 week ago and heard a "pop" and states that her back pain returned.She rates her back pain (both sides) at 8/10 today.She did not take neurontin and has not pursued acupuncture.Review of systems: patient complained of joint pain, muscle cramps.Assessment: facet syndrome 2.Postlaminectomy syndrome, cervical region 3.Degeneration of lumbar or lumbosacral intervertebral disc.(b)(6) 2011: patient presented for an office visit due to neck pain,low back pain, and medication follow-up.Patient states she got minimal relief following the last injection.Patient states no relief with the butrans patch.Patient also states she is allergic to the adhesive.Assessments 1.Degeneration of lumbar or lumbosacral intervertebral disc 2.Degeneration of cervical intervertebral disc 3.Postlaminectomy syndrome, cervical region 4.Osteoarthrosis, unspecified whether generalized or localized, unspecified site 5.Encounter for long-term (current) use of other medications.(b)(6) 2011: patient presented for office visit due to neck pain,low back pain and medication follow-up.Patient wants to increase the dosage of oxycodone as it is giving her minimal relief.Assessments 1.Degeneration of cervical intervertebral disc 2.Post laminectomy syndrome, cervical region 3.Cervical radiculopathy 4.Encounter for long-term (current) use of other medications.(b)(6) 2011: patient presented for office visit due to neck pain and low back pain.The patient is complaining of pain located in the neck (left), tailbone after a fall 3 weeks ago.The pain is described as tingling, stinging.The pain radiates to down into the left shoulder.Review of systems: patient complained of joint pain, joint stiffness, muscle cramps, tingling and numbness.Assessments: 1.Postlaminectomy syndrome, cervical region - 2.Degeneration of cervical intervertebral disc 3.Degeneration of lumbar or lumbosacral intervertebral disc 4.Encounter for long-term (current) use of other medications.As per lab reports, patient tested positive for oxycodone, noroxycodone.(b)(6) 2012: patient presented for an office visit due to low back pain and neck pain.Assessments 1.Postlaminectomy syndrome, cervical region 2.Thoracic or lumbosacral neuritis or radiculitis, unspecified 3.Cervical radiculopathy 4.Encounter for long-term (current) use of other medications 5.Osteoarthrosis, unspecified whether generalized or localized, unspecified site.(b)(6) 2012: patient presented for an office visit due to low back pain and neck pain.Patient has started to use sun chloello granules from (b)(6) which is supposed to help with well being.She feels a little better since starting it.Review of systems: patient complained of joint pain, joint swelling, joint stiffness.Assessments: 1.Encounter for long-term (current) use of other medications 2.Postlaminectorny syndrome, cervical region 3.Degeneration of cervical intervertebral disc 4.Degeneration of lumbar or lumbosacral intervertebral disc 5 osteoarthrosis, unspecified whether generalized or localized, unspecified site.(b)(6) 2012: the patient complained of pain located in the back, neck, left arm.Assessments: 1.Encounter for long-term (current) use of other medications 2.Cervical radiculopathy 3.Degeneration of lumbar or lumbosacral intervertebral disc urine drug screen administered in office, instant results were positive for oxy.Urine sent to lab for further screening.As per lab reports, patient tested positive for oxycodone, noroxycodone.(b)(6) 2012: patient presented for office visit due to low back pain and neck pain.Patient complained that pain in neck has increased with tingling and numbness.Review of systems: patient complained of joint pain, joint swelling, joint stiffness.Assessments 1.Postlaminectomy syndrome, cervical region 2.Cervicalradiculopathy 3.Thoracic or lumbosacral neuritis or radiculitis, unspecified 4.Encounter for long-term (current) use of other medications 5.Osteoarthrosis, unspecified whether generalized or localized, unspecified site.(b)(6) 2012: per office notes, "patient was found to have found to have significant cervical disc disease from c4 to c7.Patient has had persistent neck and left arm pain with crepitus and pins and needles.Her hands often hurt, especially in the c7 dermatome.She reports intermittent weakness, as well, in that arm.Physical examination: on exam, she certainly still has weakness in grip and in the intrinsic musculature on the left side, she has some tingling and numbness in the c7 dermatome." (b)(6) 2012: patient underwent following examination: spine cervical ap <(>&<)> lat due to brachial neuritis, neck and left arm pain which revealed 1.No acute osseous findings or hardware failure.2.Degenerative changes as above most pronounced at c2-c3 where there is moderate degenerative disc disease.3.Overall, the findings do not appear to be significantly change compared to (b)(6) 2010.(b)(6) 2012: patient underwent mri of cervical spine without contrast due to neck and left arm pain which revealed 1.Mild multilevel degenerative disc disease, which is overall fairly similar to the previous examination 2010.There has been slight progression c6/c7.2.At c5/c5, across the level of fusion there is no residual disc bulge or stenosis.3.The most significant central stenosis is moderate at c4/c5 ~rom circumferential disc osteophyte and some ligamentum flavum infolding.There is slight flattening of the anterior cord and effacement of the csf.Moderate bilateral foraminal stenosis at the same level.4.There are more mild bulges at the other levels without to moderate foraminal stenosis c2/c3 on the left and c3/c4 on the left as well.(b)(6) 2012: patient presented for office visit due to low back pain and neck pain.Patient complained of tingling, numbness, dizziness, arm weakness.Assessments: 1.Postlaminectomy syndrome, cervical region 2.Degeneration of lumbar or lumbosacral intervertebral disc 3.Encounter for long-term (current) use of other medications.(b)(6) 2012: patient presented for office visit due to low back pain.Assessments: 1.Postlaminectomy syndrome, cervical region 2.Cervical radiculopathy 3.Thoracic or lumbosacral neuritis or radiculitis, unspecified 4.Encounter for long-term (current) use of other medications 5.Degeneration of cervical intervertebral disc 6.Facet syndrome 7.Degeneration of lumbar or lumbosacral intervertebral disc 8.Osteoarthrosis, unspecified whether generalized or localized, unspecified site 9.Cervical spondylosis without myelopathy 10.Uns pecified myalgia and myositis 11.Unspecified constipation 12, spondylosis with myelopathy, lumbar region.(b)(6) 2012: patient called and stated that she would like a refill of mobic.Medication was started.(b)(6) 2012: patient presented for office visit due to neck pain.Assessments: 1.Encounter for long-term (current) use of other medications 2.Post laminectomy syndrome, cervical region.(b)(6) 2012: patient presented for office visit due to low back pain and neck pain.Assessments 1.Postlarninectomy syndrome, cervical region 2.Encounter for long-term (current) use of other medications 3.Thoracic or lumbosacral neuritis or radiculitis, unspecified patient underwent uds.As per lab reports, patient tested positive for oxycodone, noroxycodone.(b)(6) 2012: patient presented for office visit due to neck pain and review results of cervical spine mri.Patient states that she discontinued the mobic and the percocet takes the edge off.Patient complained of neck pain today that radiates into the shoulders and up into the head and occasionally in to the arms.Patient complained of tingling, numbness, arm weakness.Assessment: 1.Cervical radiculopathy 2.Postlaminectorny syndrome, cervical region 3.Unspecified myalgia and myositis 4.Unspecified constipation 5.Encounter for long-term (current) use of other medications 6.Facet syndrome 7.Cervical spondylosis without myelopathy 8.Degeneration of lumbar or lumbosacral intervertebral disc.Patient underwent uds.As per lab reports, patient tested positive for oxycodone, noroxycodone.(b)(6) 2012: patient presented for office visit due to low back pain and neck pain.Patient complained of neck pain radiating up the back of head.Patient complained of joint pain, joint swelling, joint stiffness.Assessments: 1.Cervical radiculopathy (primary) 2.Postlaminectorny syndrome, cervical region 3.Thoracic or lumbosacral neuritis or radiculitis, unspecified 4.Encounter for long-term (current) use of other medications.(b)(6) 2012: patient presented for office visit due to neck pain.Patient reported numbness and tingling to the left arm.Assessments: 1.Degeneration of cervical intervertebral disc 2.Cervical radiculopathy.Patient underwent cesi procedure at c6-7.(b)(6) 2012: patient presented for office visit due to neck pain.Patient stated that her pain is progressively getting worse.Assessment: encounter for long-term (current) use of other medications.Urine drug screen administered in office, instant results were positive for oxy.Urine sent to lab for further screening.As per lab reports, patient tested positive for oxycodone, noroxycodone.(b)(6) 2012: patient presented for office visit due to neck pain.Patient stated that she discussed with her pcp, and he advised stopping her prozac and initiating cymbalta which can also help with her pain.Assessments 1.Encounter for long-term (current) use of other medications 2.Facet syndrome 3.Thoracic or lumbosacral neuritis or radiculitis, unspecified 4.Cervical radiculopathy 5.Postlaminectomy syndrome, cervical region.Prozac capsule stopped and cymbalta capsule started.(b)(6) 2012: patient presented for office visit due to neck pain.Assessments: 1.Cervical radiculopathy 2.Unspecified myalgia and my ositis 3.Encounter for long-term (current) use of other medications.(b)(6) 2013: side effects of medication is stated as lethargy.Assessments: 1.Encounter for long-term (current) use of other medications 2.Post laminectomy syndrome, cervical region.On (b)(6) 2013: as per lab reports, patient tested positive for oxycodone, oxymorphone, noroxycodone.(b)(6) 2013: as per telephone encounter, patient was interested in starting physical therapy with grace pt.(b)(6) 2013: patient presented for office visit due to neck pain and low back pain.Patient states the low back is most intense at this time.Patient states her low back pain radiates into her ble.Patient complained of intermittent nausea due to lap band.Assessments 1.Postlaminectomy syndrome, cervical region 2.Thoracic or lumbosacral neuritis or radiculitis, unspecified 3.Encounter for long-term (current) use of other medications.(b)(6) 2013: patient presented for office visit due to neck pain and low back pain.Patient complained of joint pain, joint swelling, joint stiffness.Assessment: encounter for long-term (current) list of other medications.Urine drug screen done in office instant results are positive for oxy.Urine sent to labs for confirmed results.As per lab reports, patient tested positive for oxycodone, oxymorphone, noroxycodone.(b)(6) 2013: patient presented for office visit due to neck pain and low back pain.Patient complained of joint pain, joint swelling, joint stiffness.Assessment: - degeneration of lumbar or lumbosacral intervertebral disc.(b)(6) 2013: patient presented for office visit due to neck pain and low back pain.Patient complains of lower back pain radiating down the bilateral legs.Patient complaining of joint pain, joint swelling, joint stiffness.She states her right foot has been bothering her.Assessments 1.Cervicalgia 2.Chronic pain syndrome.(b)(6) 2013: patient presented for office visit due to low back pain.Side effects of the medication include sleepiness.Patient complaining of joint pain, joint swelling, joint stiffness.Assessments 1.Cervical radiculopathy 2.Post laminectomy syndrome, cervical region 3.Unspecified myalgia and myositis 4.Encounter for long-term (current) use of other medications (b)(6) 2013: patient presented for office visit due to low back pain.Patient continues to complain of lower back pain bilaterally radiating into both legs, worse on the right, down to the ankles.Patient complaining of constipation.Assessments: 1.Encounter for long-term (current) use of other medications 2.Post laminectomy syndrome, cervical region 3.Thoracic or lumbosacral neuritis or radiculitis, unspecified.Urine drug screen done in office, instant results are positive for oxy, pcp.Urine sent to labs for confirmed results.As per lab reports, patient tested positive for oxycodone, oxymorphone, noroxycodone.(b)(6) 2013: patient presented for office visit due to low back pain.Side effects of the medication include constipation.Patient complained of low back pain that radiates down the left leg.Patient states numbness and tingling in the right leg.Assessments: 1.Encounter for long-term (current) use of other medications 2.Degeneration of lumbar or lumbosacral intervertebral disc.
 
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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 Key5041582
MDR Text Key24537535
Report Number1030489-2015-02114
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 Other
Report Date 08/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received08/03/2015
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;
Patient Weight79
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