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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 Cyst(s) (1800); Edema (1820); Fever (1858); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Vomiting (2144); Weakness (2145); Cramp(s) (2193); Dizziness (2194); Stenosis (2263); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
It was reported that the patient underwent a plif and plf at l5-s1 using an interbody cage.The cage was packed with thbmp-2/acs.Bmp was also placed anteriorly in the disc space prior to insertion of the cage, as well as in the posterolateral gutters spanning the transverse processes.It was reported that post-op, the patient developed injuries including severe pain, great emotional distress, and mental anguish.
 
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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2004: the patient was admitted due to burning and sharp back pain, radiating to the right leg.The patent also complained of pain in right hip, leg.Admit diagnosis: lumbago.The patient had the following neurologic symptoms: sensory-motor loss in right leg and tingling.Physical examination: back: decreased range of motion, muscle spasm, vertebral point tenderness.The patient underwent x-rays of lumbar spine.Impression: accentuation of the lumbosacral angle.The patient also underwent x-rays of the right hip.Impression: normal findings.On (b)(6) 2004: the patient was discharged home with medications.The patient was also advised to rest and limit bending and lifting.On (b)(6)2005: the patient was admitted due to hand and finger injury while using a hammer.The patient experienced active bleeding and laceration.Principal diagnosis: open wound of finger.The patient also underwent x-rays of the left hand.Impression: no fracture or dislocation.Tiny calcified density at the dorsal base of the distal phalanx of the fifth digit.On (b)(6) 2005: the patient was discharged home.On (b)(6) 2010: the patient presented with pain and drainage in right ear, and was admitted.On (b)(6) 2011: the patient was admitted due to chronic back pain, and underwent x-rays of lumbar spine, with obliques.Impression: mild degenerative changes of the lumbar spine.Differential diagnosis revealed radiculopathy, and radiographs revealed narrowing disc space l5-s1.On (b)(6) 2011: the patient underwent mri of lumbar spine, without contrast for lumbago diagnosis.Impression: degenerative disk disease involving l3-l4, l4-l5, and l5-s1 interspaces with diffuse disk bulging narrowing the central canal and neural foramina, more severe at l5-s1 interspace.On (b)(6) 2011: the patient presented with lower back pain radiating to right leg, and was admitted.The patient also complained of sleeping trouble, hearing loss, dizziness and vision loss in both eyes.The musculoskeletal test revealed joint pain, cramps, stiffness and bone pain.Neurological test revealed headache, difficulty in walking and numbness or tingling in legs.The patient also suffers from excessive worry and anger.Admitting diagnosis: abnormal mri.The urine drug screening was tested positive.The patient was discharged home.On (b)(6) 2011: the patient presented with low back pain and was admitted.The patient also complained of knee pain and numbness in bilateral legs.Admit diagnosis: lumbago.Primary diagnosis: sprain lumbosacral.Secondary diagnosis: sciatica; lipoid metabolic discharge.On (b)(6) 2011: the patient presented for an office visit with the history of chronic low back pain for 10-15 years.The review of mri report revealed degenerative disk disease worse at l5-s1.Assessment: chronic lumbar back pain, hemorrhoids, hypertension, dyslipidemia, lumbosacral spine degenerative disc disease, bilateral inguinal herniorrhaphies, cholesteatoma c ear surgery bilateral.On (b)(6) 2011: the patient underwent nerve conduction/ electromyography tests.Interpretation: normal bilateral leg examination; clinical correlation is recommended.On (b)(6) 2011: the patient presented with chief complaints of lower back pain, bilateral leg pain and muscle pain and had following pre-op diagnosis: lumbar degenerative disc disease.The pain was reported as constant with intermittent burning.The patient displayed symptoms like hearing loss, ear pain, anxiety and depression.The patient underwent x-rays of the chest.On (b)(6) 2011: the patient presented for medication refills.Bp was borderline high.The patient complained of back pain and anxiety.Assessment: hypertension: deteriorated, chronic lumbar back pain: unchanged, dyslipidemia, hemorrhoids, lumbosacral spine degenerative disc disease.On (b)(6) 2011: the patient was admitted.The patient underwent x-rays of the chest due to degenerative disc disease at l5-s1.Impression: no acute cardiopulmonary process.The patient underwent the following test: "lab cxr ekg" 5-s1 transforaminal lumbar body fusion.On (b)(6) 2011: the patient presented with chief complaints of degenerative disc disease at l5-s1 and lumbar pain, bilateral leg pain, right greater than left, and was admitted.The patient underwent l5-s1 transforaminal lumbar interbody fusion surgery with cell saver.Preoperative diagnosis: lumbar degenerative disc disease with instability and radiculopathy at l5-s1.Procedures performed: posterior non segmental pedicle screw instrumentation, l5-s1.Posterior interbody arthrodesis using peek cage, bone morphogenetic protein and locally harvested bone graft at l5-s1.Posterolateral arthrodesis using compression resistant matrix local bone graft and bone morphogenetic protein, l5-s1.Lumbar decompression at l5-s1 to decompress the l5 nerve root.Lumbar decompression at l5-s1 to decompress the s1 nerve root.Insertion of biomechanical device at l5-s1.As per op notes, an 8-mm graft appeared to have a good fit.It was filled with bmp soaked sponge and locally harvested bone graft which had been previously morselized.A construct of locally harvested bone graft, bmp and compression resistant matrix was placed anterior into the disk space and tamped down followed by the 8-mm peek cage.The peek cage was placed ensuring no damage to the traversing nerve root.It was rotated in position and tamped anteriorly.There, a posterolateral arthrodesis was completed using 1 compression resistant matrix, bmp sponge and locally harvested bone graft.This was placed in the posterolateral gutters spanning the transverse process of l5 to the sacral ala.Once this was completed bilaterally, 30-mm rods were placed into the screw heads.A lateral radiograph was taken which showed that the pedicle screws and interbody grafts were in good position.No patient complications were noted.On (b)(6) 2011: the patient was discharged home in good condition.On (b)(6) 2011: the patient made a phone call and reported to be in a lot of pain and suffering from high fever.Patient diagnosed with lumbago due to acute post-op pain.Patient also underwent an x-ray of chest due to back pain.Impressions: normal chest.The patient also underwent an x-ray of lumbosacral spine due to back pain.Impressions: patient is stable post fusion procedure in anatomic alignment and mild degenerative change (b)(6) 2011: the patient presented with chief complaint of low back pain, post-op lumbar decompression.The patient underwent mri of lumbar spine without contrast.On (b)(6) 2011: the patient underwent mri of the lumbar spine, without contrast, due to low back pain.Impression: postsurgical changes of the posterior lumbar fusion and laminectomy at the l5-s1 level.Interbody fusion device was present.There was mild marrow edema involving the superior end plate of the s1 and inferior end-plate of l5.While this finding may represent postsurgical edema, infectious process cannot be excluded on this examination.On (b)(6) 2012: the patient presented with neck pain.On (b)(6) 2012: the patient presented with chief complaint of low back pain that radiated into bilateral hip, bilateral buttock, bilateral upper leg, bilateral knee, bilateral lower leg and bilateral feet.The pain was constant, aching, stabbing, throbbing, shooting, and numbing in nature.The pain aggravated by standing for prolonged periods, sitting for prolonged periods, walking, exercise, and climbing stairs.The patient admitted having muscular weakness, radicular pain, anxiety and depression.The patient had limitation of motion, muscle cramps, back spasms, painful joints as well.Assessment: myofascial pain syndrome, failed back syndrome (postlaminectomy syndrome) of lumbar region, lumbar radiculopathy sciatica, spasm of muscle, sleep disturbance, gait abnormality, tobacco use ,low back pain.The patient also presented for urine drug screening.Assessment: potential for nondependent abuse of drugs, other, mixed, or unspecified drug abuse, long term medication use.On (b)(6) 2012: the patient presented for lower nerve conduction velocity/electromyography.Assessment: lumbosacral radiculitis, spondylosis with myelopathy, lumbar region.The patient also underwent other electrodiagnostic tests.Impression: this was a normal electrophysiological study.Specifically, there were no findings to suggest; a lumbar radiculopathy.A dysfunction involving the deep peroneal or tibial nerves 3.A polyneuropathy or myopathy.On (b)(6) 2012: the patient was diagnosed with tobacco use disorder.Secondary diagnosis- postlaminectomy syndrome, lumbago, statica, l umbosacral neritis, spasm of muscle, myalgia and myositis, sleep disturbance and abnormality of gait.On (b)(6) 2012, (b)(6) 2013, and (b)(6) 2013: the patient presented for a follow up visit due to chief complaints of low back pain, back pain, bilateral hip pain, bilateral buttock pain, bilateral upper leg pain, bilateral knee pain, bilateral leg pain, bilateral foot pain.The low back pain had a stabbing, numbing quality which radiated into the bilateral extremities of the patient.Assessment: myofascial pain syndrome, failed back syndrome (postlaminectomy syndrome) of lumbar region, lumbar radiculopathy sciatica, spasm of muscle, sleep disturbance, gait abnormality, tobacco use ,low back pain.On (b)(6) 2012, the dosage of following medications were changed: xanax cut to bid #60 from tid #90, lorcet cut to lortab 10/500 qid #120.On (b)(6) 2012, the patient was fitted for lumbar support due to low back pain and muscle spasms.Assessment: spasm of muscle.On (b)(6) 2013, the patient was discharged.On (b)(6) 2013: the patient called the clinic on 2 separate occasions concerning receiving medication since his discharge from the clinic on (b)(6) 2013.On (b)(6) 2013: patient presented with left arm laceration.Impressions: forearm laceration, stable condition.On (b)(6) 2013: patient presented for stitches removal to the left forearm.Impressions: suture removal.Condition: stable.On (b)(6) 2013: patient presented with abscess.Diagnosis: abscess, face.On (b)(6) 2013: the patient underwent x-rays of the cervical spine due to indications of neck pain.Impression: degenerative disc and facet disease.The patient also underwent x-rays of the left shoulder due to the indication of pain.Impression: no acute findings.On (b)(6) 2013: the patient underwent mri of the cervical spine due to severe pain with decreased range of motion.Impression: mild degree of right sided foraminal stenosis due to spondylosis at c3-4 level.Moderate degree of right paracentral posterior hard disc/osteophyte bulging with moderate degree of right-sided foraminal stenosis due to spondylosis at c4-5, c5-6 and c6-7 levels.The patient also underwent mri of the left shoulder due to severe pain with decreased range of motion.Impression: study negative for rotator cuff tear.Small fluid collection in the subcoracoid bursa most likely representing localized bursitis.Mild degree of subcondylar cystic changes in the humeral head, mri left shoulder without contrast otherwise is within normal limits on (b)(6) 2013: the patient presented with sharp neck pain.The pain was aggravated due to hyperextension, rotation and turning head.Associated symptoms included difficulty sleeping, muscle spasm, tenderness and weakness.The patient also complained of back pain radiating to left arm, muscle spasms, musculoskeletal tenderness.Associated symptoms include paresthesias.Assessment: chronic spinal stenosis in cervical region; degeneration of cervical intervertebral disc; hypertension; unspecified arthropathy involving shoulder region; other bursitis disorders and cervicalgia.The patient was asked to stop smoking.On (b)(6) 2013: the patient presented with history of neck pain.Both upper extremities and hands were numb and the right side was more numb than the left.The patient was also having shoulder pain.The patient had problems when he sits, stands, bends or stoop.The patient described weakness in both upper extremities, more numbness on the fourth and fifth finger, shoulder pain and multiple joint pain including shoulder, knee and the lower back area.Sensory examination of the upper extremity revealed decreased sensation on bilateral lateral arm for light touch, temperature and pinprick sensation and dorsum of the band.Positive tinel's sign at the wrist.The upper, mid and lower cervical face joint had tenderness.Mid and lower lumbar paraspinal muscle tenderness was also noted.Lumbar spine range of motion was significantly reduced in all directions.Impression: cervical spondylosis at multiple level.Examination was mostly consistent with c5-c6 radiculopathy versus carpal tunnel syndrome versus double crush syndrome.Bilateral arm paresthesia and weakness, radiculopathy versus carpal tunnel syndrome.The patient also underwent nerve conduction/electromyography test.Interpretation: bilateral mid cervical radiculopathy.Mild right carpal tunnel syndrome.On (b)(6) 2013: the patient presented with backache and joint pain in shoulder, and was admitted.Admit diagnosis: backache, unspecified.Principal diagnosis: cervicalgia.Secondary diagnosis: joint-pain-shoulder; tobacco use disorder; other chronic pain; anxiety state, unspecified; other depressive disorder; second degree burn in back; hypertension, unspecified; other external cause status; other long term use of medications.The patient was discharged home.On (b)(6) 2014: the patient presented for follow-up and complained of musculoskeletal back pain and neck pain, hypertension and cough.Assessment: spinal stenosis in cervical region, hypertension unspecified, cervicalgia, acute bronchitis, pain in joint involving sh oulder region.The patient was asked to stop smoking.Dosage of lisinopril was increased to 20mg daily.On (b)(6) 2014: the patient presented with sharp left shoulder pain radiating to the neck and back.The pain was aggravated by lifting and movement.The patient also had chronic hypertension, cervicalgia, spinal stenosis in cervical region.Physical examination: neuro/psychiatric: insomnia, tingling in arms; musculoskeletal: decreased mobility, weakness.Mri of left shoulder was reviewed which had signs consistent with rotator cuff tendinitis and partial thickness rotator cuff tear.On (b)(6) 2014: the patient presented with low chronic back pain, neck pain and left shoulder pain.The pain is aggravated by the following factors reaching, overhead work, carrying, lifting, pulling, prolonged walking, prolonged standing, prolonged sitting and cold environment.The following symptoms were associated with this pain: numbness, muscle stiffness, cramps, weakness, nervousness, poor concentration, depression, muscle twitching and muscle spasms.The patient also complained of joint pain, swollen joints.Physical examination: neurologic: sensory: touch sensation decreased mild decrease in sharp/ dull differentiation in bilateral arms in lateral quadrants and legs, also in lateral quadrants in thighs, and anterior quadrants in lower legs.Reflexes: patellar tendon reflex decreased, hyporeflexic on both sides.Achilles tendon reflex decreased hyporeflexic on both sides.Spine: cervical spine: tenderness is noted at the trapezius and bilateral shoulder regions near neck, but not in shoulder joints.Diagnosis: thoracic or lumbosacral neuritis or radiculitis not otherwise specified; special screening examination for depression; postlaminectomy syndrome of lumbar region; cramp in limb; bone <(>&<)> cartilage "dis nos"; lumbosacral spondylosis without myelopathy/ facet arthropathy; cervicalgia; drug dependence not otherwise specified unspecified; cervical disc degeneration; shoulder region disorders not elsewhere classified; encounter for long-term use of other medications.On (b)(6) 2014: the patient presented with extreme left knee pain.Principal diagnosis: sprain of knee and leg, unspecified.The patient underwent x-rays of the left knee.Impression: suprapatellar knee joint effusion with no evidence of acute fracture.On (b)(6) 2014: the patient underwent mri of the knee due to knee pain and strain injury.Impression: strain injury of anterior bundle of anterior cruciate ligament, medial and lateral collateral ligament.No evidence of acute fractures.No evidence of meniscal tears.Joint effusion with thickening of the synovium due to synovitis.On (b)(6) 2014: the patient underwent x-rays of the chest.Impression: no acute radiographic findings.On (b)(6) 2014: the patient presented with a history of low back pain with shooting pain down the legs.Low back pain was constant down the legs with tingling and numb feeling left side worse than right side.Pain on "vas was about 10/10.Impulse pains were present as well.The patient also had neck, left arm pain, left shoulder blade pain, knee pain.Sitting, standing, bending, stooping, lifting, and driving aggravated the pain.The examination of cervical facet joint revealed tenderness over the base of the neck.Spasm was present.Spurling's test was positive on the left side.Tenderness over the shoulder blade and trapezius area was noted.The examination of the "si" and lumbar facet joint revealed moderate to severe tenderness, spasm, bilateral sacroiliac joint tenderness with positive patrick test, fabere test, pelvic compression test, gaenslen's test, fortin finger test.Examination of left shoulder revealed joint line tenderness, crepitus and tenderness over the subacromial space and examination of the left knee joint line tenderness, mild swelling, and crepitus.The patient was mentally depressed.Assessment: low back pain.Right lower extremity radiculitis with paresthesia.Status-post back surgery.Postlaminectomy syndrome with scarring.Radiculitis, despite pain.Neuropathy.Neck pain.Left arm radiculitis with paresthesia.Left shoulder blade pain.Bursitis.Arthritis.Left knee pain arthritis.Desiccation between the l5-s1 level with degenerative changes grade i spondylolisthesis at l5 over s1 level encroachment of the disc at l5 and s1 into the left paracentral recess.Mri of the left shoulder was also reviewed which showed small fluid collection bursa and some cystic changes in humeral head.X-ray of the c-spine showed degenerative disc disease with disc space narrowing at c4-cs and c5-c6 level with facet hypertrophy.X-ray of the left shoulder and osteophyte inferior to the distal clavicle.On (b)(6) 2014: the patient presented with lower back pain radiating down bilateral legs.Physical examination: lumbar spine revealed surgical scar.Range of motion was restricted with flexion, extension, right lateral bending and left lateral bending.Bilateral lumbar facets tender to palpation.On examination of paravertebral muscles, tenderness and tight muscle band was noted bilaterally.Spinous process tenderness was noted on l3, l4 and l5.Diagnosis: thoracic or lumbosacral neuritis or radiculitis not otherwise specified; special screening examination for depression; postlaminectomy syndrome of lumbar region; cramp in limb; bone <(>&<)> cartilage "dis nos"; lumbosacral spondylosis without myelopathy/ facet arthropathy; cervicalgia; opoid type dependence continues; drug dependence, unspecified; cervical disc degeneration; shoulder region disorders not elsewhere classified; encounter for long-term use of other medications.The patient also underwent ct scan of the lumbar spine due to history of lumbar fusion 4-5 years ago, chronic increasing low back pain, and bilateral leg pain.Impression: 1.Transitional vertebra at s1.2.Moderate bilateral foraminal stenosis at l4-5.3.Postoperative changes at l5-s1 with no solid fusion, probable small central disc protrusion, moderate bilateral foraminal stenosis and mild canal stenosis.4.Postoperative changes at s1-2 with solid intervertebral body and posterior lateral fusions, bilateral posterior lateral endplate spurring especially on the right, moderate to severe foraminal stenosis on the right and possible epidural fibrosis lateral to the dural sac on the right.5.10 mm x 20 mm low-density lesion in the right lobe of the liver, probably a cyst.6.Possible cholelithiasis.On (b)(6) 2014: the patient presented with low back pain radiating to both legs and hips, tingling in legs.Physical examination: lumbar spine: range of motion is restricted with flexion and extension.On examination of paravertebral muscles, tenderness was noted bilaterally.Diagnosis: thoracic or lumbosacral neuritis or radiculitis not otherwise specified; special screening examination for depression; postlaminectomy syndrome of lumbar region; cramp in limb; bone <(>&<)> cartilage "dis nos" lumbosacral spondylosis without myelopathy/ facet arthropathy; cervicalgia; opoid type dependence continues; drug dependence not otherwise specified unspecified; cervical disc degeneration; shoulder region disorders not elsewhere classified; encounter for long-term use of other medications.The patient also presented for a psychiatric visit.Diagnostic impression: generalized anxiety disorder; post-traumatic stress disorder.On (b)(6) 2014: the patient presented with constant lower back pain radiating to the back of the legs and knees, tingling and numbness in legs, spasms in legs.The pain was aggravated while driving and bending.Physical examination revealed range of motion was restricted with flexion, extension.On examination of paravertebral muscles, tenderness and tight muscle band was noted bilaterally.Spinous process tenderness is noted on lumbar spine.Diagnosis: low back pain.
 
Manufacturer Narrative
Per the image review, the findings are as follows: (b)(6) 2011 chest x-ray pa and lateral views show normal chest cavity, normal lung fields, cardiac shadow, bony anatomy and breast shadows.Lateral view shows normal thoracic kyphosis.No fractures or advanced degenerative changes.On (b)(6) 2011 lumbar lateral x-rays lateral view showing localizing probe at the l4 disc.No clear malalignment, fracture or degenerative change is apparent.Subsequent lateral film shows pedicle screws in l5 and s1.Final lateral shows screws, rods spanning l5 and crescent spacer within the l5 disc.On (b)(6) 2011 chest x-ray pa view show normal chest cavity, normal lung fields, cardiac shadow, bony anatomy and breast shadows.Lateral view shows normal thoracic kyphosis.No fractures or advanced degenerative changes.Lumbar x-rays ap, lateral and spot show normal bony anatomy.Construct at l5/s1 is again seen with spacer within the l5 disc.On (b)(6) 2011 lumbar mri sagittal stir views show edema about the l5 disc.Edema is also seen in the posterior elements.Conus is at t12/l1.No stenosis is appreciated.Axial views show some degree of scaring and possible bone in the right l5 lateral gutter.No obvious stenosis is noted centrally or in any foramen.On (b)(6) 2014 left knee x-rays ap, lateral and oblique views of the left knee show normal alignment.Bone density appears normal.No signs for fracture, subluxation, arthritis or deformity is appreciated.On (b)(6) 2014 right knee x-rays ap, lateral and oblique views of the right knee show normal alignment.Bone density appears normal.No signs for fracture, subluxation, arthritis or deformity is appreciated.Right foot x-rays three views of the right foot appears normal.Forefoot, midfoot and hindfoot alignment are normal.Ankle joint a ppears normal although it is not ideally imaged.Right hip x-ray single ap view appear normal.No joint space narrowing is appreciated.Bone density is normal.On (b)(6) 2014 right knee mri effusion is noted posterior medial.Menisci, cruciates appear normal.Bone signal of distal femur and proximal tibia are normal.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2004: the patient underwent mri of lumbar spine.Impression: no evidence of any significant spinal stenosis.The facet joints appear normal.Desiccation of the disc between l5 and s1 vertebrae from degenerative changes.Grade one listhesis of l5 over s1 vertebrae.There was an encroachment by the disc between l5 and s1 into the left paracentral recess.(b)(6) 2011: the patient presented with pain in low back.Assessment: back pain low, muscle spasm, opioid dependence, radiculopathy.(b)(6) 2011: the patient presented with pain in low back.Assessment: muscle spasm, opioid dependence, radiculopathy, back pain low.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on on (b)(6) 2015 the patient presented for follow-up appointment.Assessment: hypertension, dyslipidemia, hemorrhoids, chronic lumbar back pain, degenerative disc disease of lumbosacral spine.On (b)(6) 2012: patient presented for balance test.Assessment: dizziness and giddiness; drugs, medicinal and biological substances causing adverse effects in therapeutic use; analgesics, antipyretics, and antirheumatics; other opiates and related narcotics; encounter for other and unspecified procedures and aftercare; other specified procedures and aftercare; encounter for therapeutic drug monitoring.On (b)(6) 2012, (b)(6) 2013: he patient also presented for urine drug screening.Assessment: potential for nondependent abuse of drugs, other, mixed, or unspecified drug abuse, long term medication use.
 
Event Description
(b)(6) 2011: the patient presented with lower back pain radiating to right leg, and was admitted.Patient pain complaint states left upper leg always numb.The patient also complained of sleeping trouble, hearing loss, dizziness and vision loss in both eyes.The musculoskeletal test revealed joint pain, cramps, stiffness and bone pain.Neurological test revealed headache, difficulty in walking and numbness or tingling in legs.The patient also suffers from excessive worry and anger.Admitting diagnosis: abnormal mri.The urine drug screening was tested positive.The patient was discharged home.(b)(6) 2011: the patient presented with chief complaints long standing history of lower back pain mainly from a work accident in 1996, bilateral leg pain and muscle pain and had following pre-op diagnosis: lumbar degenerative disc disease.The pain was reported as constant with intermittent burning.The patient displayed symptoms like hearing loss, ear pain, anxiety and depression.Physical exam: severe pain on flexion, extension & axial rotation of lumbar spine.Strength 5/5 in all muscle groups bilaterally upper & lower extremities.Reflexes: 2/4 symmetric in all four extremities.Musculoskeletal: faber negative, straight leg raising negative.Rom: cervical & lumbar spine = normal the patient underwent x-rays of the chest.Progress note: l5-s1 tlif fusion, r>l (b)(6) 2011: radiograph lumbar spine 1 view: metallic probe is localizing the l4-l5 disk level for site verification prior to surgical intervention.(b)(6) 2011: radiograph lumbar spine 1 view: interpedicular screws are seen at the l5 & s1 level.Hardware intact, alignment appears stable.(b)(6) 2011: radiograph lumbar spine 1 view: exam reveals placement of an intervertebral disk spacer at the l5-s1 level.Posterior rods have also been applied to the interpedicular screws at the l5-s1 level.Surgical hardware appears to be in adequate position.(b)(6) 2011: neurosurgical office note: patient is 1 month out from lumbar decompression 7 fusion.Doing relatively well.Wound is clean, dry & intact.(b)(6) 2011: patient called to request lortab refill.(b)(6) 2011: patient called to request neurontin refill (b)(6) 2011: follow-up for mri results for back pain.(b)(6) 2011: neurosurgery note: history- patient is 3 months out from lumbar fusion.Doing well with an increase in activity, back at work.Wound is clean, dry & intact.Obtained mri that shows good bony fusion.(b)(6) 2013: establish new primary care provider.History: neck pain, gradual onset, duration 10 years, problem is severe.Pain is constant.The patient presented with sharp neck pain.The pain was aggravated due to hyperextension, rotation and turning head.Associated symptoms included difficulty sleeping, muscle spasm, tenderness and weakness.The patient also complained of back pain radiating to left arm, muscle spasms, musculoskeletal tenderness.Associated symptoms include paresthesias.Assessment: chronic spinal stenosis in cervical region; degeneration of cervical intervertebral disc; hypertension; unspecified arthropathy involving shoulder region; other bursitis disorders and cervicalgia.The patient was asked to stop smoking.(b)(6) 2014: the patient presented for follow-up and complained of musculoskeletal back pain and neck pain, hypertension and cough.Has seen neurosurgeon for neck pain who recommended surgery and patient does not want to pursue at current time.Could not get into pain management with physician until may but has seen other provider & broke narcotic agreement.Assessment: spinal stenosis in cervical region, hypertension unspecified, cervicalgia, acute bronchitis, pain in joint involving shoulder region.The patient was asked to stop smoking.Dosage of lisinopril was increased to 20mg daily.(b)(6) 2014: presents with left knee pain (follow-up).Patient stated fluid was recently drawn off his knee that was bloody in nature.Assessment: mri of left knee has signs consistent with medial meniscal tear per my read.There is also large knee joint effusion noted.Operative & non-operative management discussed, patient does not want surgery at this time.Will use conservative treatment.(b)(6) 2014: long term medication use, therapeutic drug monitor.Drug testing negative.(b)(6) 2014: emergency room visit.Walked out the door & fell 2 feet.Did not fall on the ground.Now with joint pain, leg pain, right ankle & pelvis pain.Radiograph right foot-negative.Radiograph ap right hip.No evidence of acute fracture.Radiograph right knee: suprapatellar knee joint effusion with mild arthritic changes of the right knee.(b)(6) 2014 history: right knee pain- 3 nights ago patient fell out of house- a 4 foot drop, landed on right foot.Instant right sided pain.Sitting/standing makes knee throb/sharp pain.Patient reports visiting er for x-rays of foot, knee & hip on r side.Foot & hip were negative.R knee: suprapatellar knee joint effusion with mild arthritic changes.Assessment: hypertension, joint pain.(b)(6) 2014: mri right knee without contrast.Impression: chondromalacia patella with full thickness cartilaginous defect.Mild femorotibial chondromalacia.Other mild changes of osteoarthrosis.Suprapatellar joint effusion.No internal derangement of the knee.(b)(6) 2014- patient reports right knee pain-constant & worsening.No radiation.Follow-up to mri.Context: there is no injury.Right knee joint injection: ketorolac tromethamine.Patient is ready to schedule left knee surgery.
 
Event Description
It was reported that on (b)(6) 2015, (b)(6) 2015 the patient was presented for office visit with low back pain.Diagnosis : thoracic or lumbosacral neuritis or radiculitis; postlaminectomy syndrome of lumbar region; cramp in limb; bone <(>&<)> cartilage dis nos; lumbosacral spondylosis w/o myelopathy/ facet arthropathy; cervicalgia;opioid type dependence continuous; drug dependence not otherwise specified unspecified; cervical disc degeneration; lumbar or lumbosacral disc degeneration; lumbago.
 
Manufacturer Narrative
(b)(6).(b)(4).
 
Event Description
It was reported that on (b)(6) 2014: patient presented for an office visit.Review of neurological system: difficulty initiating sleep, nocturnal awakening.Assessment: patellofemoral syndrome.Impression: mri of right knee reveals patella chondromalacia and question small medial meniscal tears.On (b)(6) 2014 patient presented for office visit with complaint of left knee pain.On (b)(6) 2015 patient presented for office visit because of nausea with vomiting.Patient presented with chief complaint of side pain.Patient underwent ct abdomen and pelvis without or oral contrast.Impression: patient has small non-obstructing kidney stones bilaterally.Question gallstones.On (b)(6) 2015 patient underwent ecg test.Patient presented with chief complaint of constipation and fever, abdominal pain, nausea.Ultrasound o f right upper quadrant was done as well as a ct scan of abdomen and pelvis, and both studies are consistent with acute calculous cholecystitis.Patient underwent ct abdomen and pelvis with contrast.Impressions: imaging findings most compatible with acute cholecystitis.No gi or gu tract obstruction.Mild constipation noted.Other mild chronic findings as above.Patient underwent ultrasound gallbladder.Impressions: imaging findings compatible with acute cholecystitis.Assessment: sepsis-improving, cholecystitis, hypertension, anxiety and depression, back pain.On (b)(6) 2015 patient underwent following diagnosis: gallbladder, cholecystectomy: acute of chronic cholecystitis.Patient underwent ct of single view chest.Impression: normal chest.Patient presented with preoperative diagnosis of acute calculous cholecystitis and underwent laparoscopic cholecystectomy, extensive lysis of adhesions.On (b)(6) 2015 patient underwent x-ray chest.Impression: normal chest.On (b)(6) 2015 patient discharged with following final diagnosis: acute gangrenous cholecystitis, status post laparoscopic cholecystectomy, lysis of adhesions.On (b)(6) 2015 patient presented for office visit post operation.
 
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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 Key4215461
MDR Text Key5039546
Report Number1030489-2014-04180
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,consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/12/2016
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 Date10/01/2013
Device Catalogue Number7510800
Device Lot NumberM111052AAA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/01/2014
Initial Date FDA Received10/30/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received03/25/2015
04/15/2015
06/19/2015
07/27/2015
03/10/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/20/2011
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 Weight99
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