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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abrasion (1689); Emotional Changes (1831); Fall (1848); Headache (1880); Hypersensitivity/Allergic reaction (1907); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Pneumonia (2011); Loss of Range of Motion (2032); Sprain (2083); Swelling (2091); Weakness (2145); Burning Sensation (2146); Tingling (2171); Cramp(s) (2193); Stenosis (2263); Discomfort (2330); Joint Swelling (2356); Inadequate Pain Relief (2388); Numbness (2415); Irritability (2421); Neck Stiffness (2434); Shaking/Tremors (2515); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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It was reported that on or about (b)(6) 2009, the patient underwent a plif at l4-l5 in which an interbody cage and rhbmp-2/acs were used.The cage was packed with bmp2.Reportedly, following the surgery the patient continued to experience low back pain and began to develop radiating pain to his legs.He reportedly underwent two procedures to remove hardware at the fusion site.It was reported that the patient continues to experience daily, disabling pain that prevents him from performing many basic activities of daily living.
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Manufacturer Narrative
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(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on, on (b)(6) 1989, the patient underwent x ray examination of right shoulder.No bony fracture was found.The patient also underwent examination of left clavicle.No fracture was identified at this time.The patient underwent x rays of the chest.Impression: no bony abnormality and normal chest.Radiographs of the cervical spine revealed normal cervical spine.On (b)(6) 1991, the patient underwent x rays of the left ankle.Impression: multiple well corticated ossific densities about the left ankle with findings suggesting associated joint effusion.These are believed to represent intra-articular fragments from previous trauma and clinical co-ordination.On (b)(6) 1991, the patient underwent x rays of the chest.Conclusion: normal chest.On (b)(6) 1993, the patient underwent ct scan of the lumbar spine.Impression: no definite evidence of herniated nucleus pulposus.Chronic changes at the left lateral recess l4-l5.On (b)(6) 1993, the patient presented for physical therapy initial evaluation.On (b)(6) 1993, the patient presented with complaints of increased low back soreness and pain.The patient had shooting pain in the low back and left buttock.The patient also reported tenderness and numbness.On (b)(6) 1998, the patient presented with chest pain.The patient reported that coughing, breathing, burping or moving causes pain.On (b)(6) 2003, (b)(6) 2004 the patient presented with chief complaint of having a foreign body in eye.The patient had blurry vision.Diagnosis: abrasion-corneal, left.On (b)(6) 2004, the patient also underwent x rays of the chest due to chest pain.Impression: normal chest portable.On (b)(6) 2004 the patient was discharged with the following diagnosis: 1.Atrial fibrillation converted to normal sinus rhythm.2.Hypercholesterolemia.On (b)(6) 2005 the patient presented for an office visit due to traumatic eye, pain, redness, tearing, scratchiness and photophobia.On (b)(6) 2006 the patient underwent x rays of the lumbar spine due to back pain.Impression: mild scoliosis.On (b)(6) 2006, (b)(6) 2007, (b)(6) 2008: the patient presented with chief complaint of back pain.The patient reported lower back pain on the left side with radiation down the leg.Patient's pain was dull and it aggravated with movement and decreased in certain positions.Patient also had some numbness.Examination revealed that the patient had pain, spasm in the left lower paravertebral musculature lumbar region and a limited range of motion.Diagnosis: low back pain.(b)(6) 2007, the patient underwent mri of the lumbar spine due to "l-s" strain.Impression: moderately large left lateral disk protrusion l4-l5.Of note the canal is somewhat small on a developmental basis with somewhat short pedicles.The patient also underwent "sinus paranasal" views.Result: no intraorbital metallic foreign body is identified.The sinuses appear clear.There is limited aeration of frontal sinuses.In addition, the patient underwent x rays of the lumbar spine.Impression: mild endplate spurring l3-l4 and l4-l5.Transitional segment on the left at the lumbosacral junction.(b)(6) 2008: the patient presented for an office visit due to chief complaint of left leg pain.On (b)(6) 2009 as per the patient exam history the patient underwent ct scan for lumbar spine.Impression: 1.Post operative changes of left partial facet removal at l4-l5 with effacement of fat within the left l4-l5 epidural space and neural foramen.2.Mild central canal stenosis at l3-l4 and l4-l5.3.Possible transitional anatomy.The patient also presented for an office visit due to left leg pain.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.Impression: degenerative disk disease at l3-l4 through l5-s1.There is no instability.On (b)(6) 2009 as per the patient exam history the patient underwent ct scan lumbar spine.Impression: postoperative changes of l4-5 posterior lumbar interbody fusion with no gross evidence of hardware complications the patient also underwent fluoroscopy.As per the billing records, patient used bone graft rhbmp-2 -c, rod-g, screw-f, screw pp.Patient presented with following preop diagnosis: mechanical low back pain, left leg pain, left l5 radiculopathy, history of previous l4-5 microdiscectomy on the left, resection of left l4-5 facet joint spinal instability l4-5 and underwent the following procedure: l4 laminectomy for decompression of the left l5 nerve root, posterior lumbar fusion l4-5 using interbody cage with bone morphogenic protein, locally harvested autograft, pedicle screw instrumentation.Per the op notes, the posterior lamina at l4 was removed with the leksell rongeur.A disc space scraper was placed in the interspace.The endplates were prepared using this.8 mm, 9mm, and 10 mm of this were used.The cage was then loaded with bone morphogenetic protein soaked sponge.Bit of autograft was taken and was placed within the disc space prior to placing the cage.After placing the autograft using 10 mm trial.Cage was then obtained with bmp and placed under fluoroscopic guidance into the interspace.Using legacy instrumentation, pedicle screws were placed at l4-5 using fluoroscopic guidance.All screws were 6.5 mm x45 mm in length which were placed on the right side.Bmp rolled sponges with autograft were then placed over the bleeding bone from the l5 lamina superiorly to the area of facet joints bilaterally.Bars were then placed to hold the bmp soaked sponges in place over the facet joint and caps replaced.Fluoroscopy confirmed good location of all screws.No patient complications were reported.On (b)(6) 2009 the patient was discharged with discharge diagnosis of low back pain , left leg pain, left l5 radiculopathy, history of previous l4-5 microdiscectomy on the left, resection of left l4-5 facet joint, spinal insatiability l4-5.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.Impression: 1.Transitional lumbosacral anatomy with stable appearance to posterior fusion of l5-s1.No evidence of hardware complications.The patient also presented for a postoperative visit due to radiating pain into the thighs and calves.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.Impression: post surgical changes status post l4-5 decompression and posterior body fusion with no radiographic evidence of hardware complication.No evidence of instability on lateral flexion-extension views.The patient also presented for a neurosurgery office visit.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.The patient presented for an office visit due to continued back and left leg pain.Impression: post surgical changes with no radiographic evidence of hardware complication.Limited range of motion on lateral flexion-extension views with focal change alignment to suggest a site of instability.On (b)(6) 2009 as per the patient exam history the patient underwent ct scan for lumbar spine.Impression: 1.Post-surgical changes of posterior lumbar interspace fusion at l4-5 with left l4/5 partial facet removal.Interval resolution of gas within surgical bed.2.Soft tissue density and effacement of fat within the left epidural space and lateral recessat l4-l5, likely scar tissue.3.Mild central canal stenosis at l3-l4 and l4-l5.On (b)(6) 2009 as per the patient exam history the patient underwent fluoroscopy.Patient presented with following preop diagnosis: history of posterior l4-5 instrumented fusion, continued left pain consistent with l4-5 radiculopathy, mild violation of medial pedicle wall with instrumentation.Procedure: removal of left sided instrumentation, l4-5 fusion.On (b)(6) 2009 the patient was discharged home with diagnosis of back pain and leg pain post lumbar fusion.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.Impression: post surgical changes with no radiographic evidence of hardware complication.Removal of left sided pedicle screws.The patient also presented with low back pain.On (b)(6) 2010 the patient presented with complaints of back and left leg pain.The patient had tenderness over his low back in the area of his scar.On (b)(6) 2010 as per the patient exam history the patient underwent xrays for lumber spine.Impression: 1.Post surgical changes from prior l4-l5 posterior decompression and interbody fusion without evidence of hardware complication or failure.2.There are no acute bone abnormalities.On (b)(6) 2010 as per the patient exam history the patient underwent mri for lumbar spine.Impression: 1.Postoperative changes of the posterior lumbar decompression and instrumented interbody fusion at l4-l5.Interval removal of hardware on the left side.2.Degenerative changes in the lumbar spine most prominent at l3-l4 with bilateral mild neural foraminal stenosis and mild central canal stenosis.On (b)(6) 2010 the patient presented with pre-op diagnosis of left leg pain, tinel sign over peroneal nerve at the fibular head and underwent decompression of the peroneal nerve on the left at the level of the fibular head.On (b)(6) 2010 the patient presented for an office visit and reported radiating pain.On (b)(6) 2010 as per the patient exam history the patient underwent xrays for lumbar spine.Impression: postsurgical changes from prior l4-l5 posterior decompression and interbody fusion without evidence of hardware complication or failure.The patient presented for a follow- up due to back pain.The right sided symptoms radiated to the calf and then to foot.(b)(6) 2010 the patient underwent decompression of the right peroneal nerve at the fibular head.The patient presented with pre-op diagnosis of right leg pain, right lower leg numbness, tinel sign over peroneal nerve at the knee.(b)(6) 2010 the patient presented for an office visit.The reason for visit was wound check and postoperative evaluation.On (b)(6) 2010 as per the patient exam history the patient underwent mri for lumbar spine.Impression: 1.Stable post-surgical changed from l4-5 posterior decompression and fusion.2.Slightly increased disc dessication at l2-3 and l3-4.3.No other significant interval change with mild to moderate scattered degenerative changes.On (b)(6) 2010 the patient underwent x-rays of the chest due to pneumonia.Impression: normal chest.On (b)(6) 2011 as per the patient exam history the patient underwent mri for lumbar spine.Impression: 1.Stable post surgical changes of posterior lumbar decompression and right sided instrumented inter body at l4-l5.2.Degenerative changes in the lumbar spine most prominent at l3-l4 with mild central stenosis and bilateral mild neural foraminal stenosis.(b)(6) 2011 the patient presented for a follow up visit complaining of low back and leg pain.The patient also underwent "emg" study.Interpretation: normal study.There was no electrodiagnostic evidence of a focal neuropathy, plexopathy or radiculopathy.(b)(6) 2011: the patient presented with follow-up with complaints of back pain going down the leg, lower backache, left lower extremity pain and right lower extremity pain.He describes the pain as burning and sharp.Pain has been continues and varies in intensity.Review of systems revealed decreased rom, joint swelling, muscle cramps, muscle tenderness, back pain, joint pain, leg pain, muscle pain, stiffness, localized weakness, numbness, seizures, tingling, tremors, depression, mood swings, nervousness, tension.The patient underwent the procedure of toxicology screen and left selective nerve root block at l2-3, l3-4, l4-5.No patient complications.On (b)(6) 2012 as per the patient exam history the patient underwent mri for thoracic spine.Impression: unremarkable mri thoracic spine examination.The patient also underwent mri for lumbar spine(impression: unchanged postsurgical changes of posterior lumbar decompression at l4-l5 and degenerative changes most conspicuous at l3-l4 compared to (b)(6) 2011.And xrays for lumbar spine.Impression: post-operative changes at l5-l6.No significant interval change from prior examination.There are no findings of instability.On (b)(6) 2012 as per the patient exam history the patient underwent 3 phase bone scanning of the lumbar spine.Impression: post surgical changes are present from laminectomy and fusion at l4-5; disc and degenerative changes are present at this level as well.There is evidence that some of the prior hardware was removed, however unilateral right-sided pedicle screws and a connecting rod remain.There is no evidence of hardware loosening or pseudoarthrosis formation.The sacroiliac joints appear unremarkable as well.(b)(6) 2012 the patient underwent "emg" study for evaluation of radiculopathy.(b)(6) 2014 the patient was discharged home with well healed lumbar fusion and diagnosis of painful instrumentation and back pain.(b)(6) 2014 the patient was presented for office visit with low back pain, intermittent pain, weakness and paresthesias.(b)(6) 2014 the patient presented for a post-op visit due to muscle spasms in lower back.(b)(6) 2014, patient presented with chief complaint of lower backache.Musculoskeletal examination findings: "stuck" in back with crane 15 yrs ago sustaining fractures.Muscle aches, muscle cramps, tenderness, back pain, pins and needles.Gait: the patient has awkward gait, has slowed gait, has an unsteady gait.Limited spinal flexion with associated lbp, denies radiation of pain.Neurological examination findings: headache, sleep difficulty.Sensation is intact to light touch.Deep tendon reflexes are 2/4, equal and symmetric bilaterally in the upper and lower extremities.On (b)(6) 2015 as per patient exam history the patient underwent mri for mri of lumbar spine due to back and left leg pain and numbness.Impression: 1.Interval removal of hardware at l4-l5 instrumented lumbar interbody fusion site.2.Intact and alignment and no nerve root compression.On (b)(6) 2015, the patient presented for a follow up of lower backache.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2007 the patient presented with complaints of constant pain with numbness, tingling and sharp pains down the lateral aspect of the left leg.He had very intense pain around the hip joint.On (b)(6) 2011 the patient presented with low back pain post surgery.He has tingling and numbness in the left leg to toes and lower back.On (b)(6) 2012 patient was presented for office visit with back and left leg pain.On (b)(6) 2012 patient was presented for office visit with back and left leg pain with numbness.The patient also underwent mri of the lumbar and thoracic spine.Impressions: the thoracic spine does not show any significant central canal stenosis.He does have a disc bulge at l3-4 eccentric to the left side.This may cause some moderate lateral recess narrowing.He has post-surgical changes at l4-5 with an instrumented fusion.On (b)(6) 2012 the patient was presented for office visit with lower back ache, bilateral lower extremity pain.Impressions: lumbar spondylosis, lumbar degenerative disc disease, paravertebral facet joint hypertrophy, lumbar spinal stenosis, lumbago, sciatica, lumbar or thoracic radiculitis, muscle spasms.On (b)(6) 2012 the patient was presented for office visit with right leg pain.The patient underwent ct scan of lumbar spine.Impressions: there was some mild increase in the facet joint on the left at the l3-4 level just above his fusion.On (b)(6) 2012 patient was presented for office visit lower back ache, left lower extremity pain and right lower extremity pain.Impressions: lumbar spondylosis, lumbar degenerative disc disease, paravertebral facet joint hypertrophy, lumbar spinal stenosis, lumbago, sciatica, lumbar or thoracic radiculitis, muscle spasms.On (b)(6) 2012 patient was presented for office visit with low back pain and leg pain.Also reported discomfort and weakness.On (b)(6) 2012 the patient was presented for office visit with lower back ache, left lower extremity pain.Impressions: lumbar spondylosis, lumbar degenerative disc disease, paravertebral facet joint hypertrophy, lumbar spinal stenosis, lumbago, sciatica, lumbar or thoracic radiculitis, muscle spasms.On (b)(6) 2013 the patient was presented for office visit.Impressions: lumbar degenerative disc disease; spinal stenosis.On (b)(6) 2014 the patient was presented for office visit with significant amount of mechanical low back pain in addition to bilateral leg symptoms.On (b)(6) 2014 the patient was presented for office visit with low back pain.On (b)(6) 2014 the patient was presented for office visit with back pain.On (b)(6) 2015 the patient was presented for office visit with continuous back and bilateral leg pain syndromes.Also reported numbness in the right leg.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that: (b)(6) 2007, patient underwent stress ecg.Interpretation: no chest pain associated with exertion ; negative ecg stress test.On (b)(6) 2007, the patient underwent some lab test -hematology, chemistry test , (b)(6) 2007 - the patient presented with chief complaint of low back pain with sciatica.He underwent physical examination.Impression: left l4-5 hnp , left leg weakness <(>&<)> paresthesias, low back pain with left radiculopathy (b)(6) 2007: patient underwent pathology test for disc tissue l4-5 and his admitted diagnosis was displacement of lumbar intervertebral disc without myelopathy (b)(6) 2008, the patient presented for cardiac checkup.(b)(6) 2008, patient underwent stress ecg.Interpretation: no chest pain associated with exertion; negative ecg stress test.On (b)(6) 2011, the patient presented with abdominal pain and epigastric.He underwent laproscopic cholecystectomy on (b)(6) 2011.Patient also underwent radiography examination.Conclusion: high rigt diaphragm as described.Otherwise negative chest.Impression from ct scan abdomen and pelvis with iv contrast: irregular gallblader wall with significant surrounding inflammation and fluid with moderate amount of fluid tracking into the pelvis.(b)(6) 2011, patient presented for general evaluation of his health and medicine refill.He underwent lab tests like cbc plus differential, bmp (basic metabolic profile) , urinalysis, (b)(6), transthoracic echocardiogram (b)(6) 2011, per op notes, patient presented for f/u post his surgery.On (b)(6) 11, the patient presented with gangrenous gallbladder.The patient tolerated the procedure well and was discharged in stable condition.On (b)(6) 2014: there was small amount of bleeding on dressing.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2010 the patient underwent decompression of the right peroneal nerve at the fibular head.(b)(6) 2010 the patient presented for an office visit.On (b)(6) 2010 as per the patient exam history the patient underwent mri for lumbar spine.The patient underwent decompression of the peroneal nerve at the fibular head, right leg.(b)(6) 2011 the patient presented for a follow up visit and complained of back and left leg pain.The patient underwent x-ray and mri tests.Impression: low back pain, lumbago.Lumbar post laminectomy, lumbar radiculitis, unspecified.Lumbar spinal stenosis, lumbar degenerative disc disease without myelopathy.Lumbar herniated nucleus pulposus without myelopathy, radiculitis.Lumbar spondylosis without myelopathy.Paravertebral facet joint hypertrophy.Sciatica.Spasm of muscle.(b)(6) 2011 the patient presented with lumbar selective nerve root block.He complained that the pain showed no improvement.The patient underwent x-ray and mri tests.Impression: low back pain, lumbago.Lumbar post laminectomy, lumbar radiculitis, unspecified.Lumbar spinal stenosis, lumbar degenerative disc disease without myelopathy.Lumbar herniated nucleus pulposus without myelopathy, radiculitis.Lumbar spondylosis without myelopathy.Paravertebral facet joint hypertrophy.Sciatica.Spasm of muscle.(b)(6) 2011, (b)(6) 2011 the patient presented for a follow up visit complaining of low back and leg pain.(b)(6) 2011 the patient presented for a follow up visit complaining of low back and leg pain.The patient underwent x-ray and mri tests.Impression: low back pain, lumbago.Lumbar post laminectomy, lumbar radiculitis, unspecified.Lumbar spinal stenosis, lumbar degenerative disc disease without myelopathy.Lumbar herniated nucleus pulposus without myelopathy, radiculitis.Lumbar spondylosis without myelopathy.Paravertebral facet joint hypertrophy.Sciatica.Spasm of muscle.(b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011 the patient presented for a follow up visit with the complaint of back pain going down the leg, lower backache, left lower extremity pain and right lower extremity pain.Impression: lumbago, lumbar post laminectomy, lumbar or thoracic radiculitis, lumbar spinal stenosis, paravertebral facet joint, hypertrophy, lumbar spondylosis without myelopathy, lumbar herniated nucleus pulposus, without myelopathy, lumbar disc degenerative disease without myelopathy, sciatica, muscle spasms.(b)(6) 2012 the patient presented for a follow up visit complaining of low back and leg pain.(b)(6) 2012 the patient presented for a follow up visit with the complaint of back pain going down the leg, lower backache, left lower extremity pain and right lower extremity pain.Impression: lumbago, lumbar post laminectomy, lumbar or thoracic radiculitis, lumbar spinal stenosis, paravertebral facet joint, hypertrophy, lumbar spondylosis without myelopathy, lumbar herniated nucleus pulposus, without myelopathy, lumbar disc degenerative disease without myelopathy, sciatica, muscle spasms.(b)(6) 2012 the patient presented for a follow up visit with the complaint of back pain going down the leg, lower backache, left lower extremity pain and right lower extremity pain.Impression: lumbago, lumbar post laminectomy, lumbar or thoracic radiculitis, lumbar spinal stenosis, paravertebral facet joint, hypertrophy, lumbar spondylosis without myelopathy, lumbar herniated nucleus pulposus, without myelopathy, lumbar disc degenerative disease without myelopathy, sciatica, muscle spasms.(b)(6) 2012 the patient presented for a follow up visit with continued low back and leg pain.(b)(6) 2014 the patient underwent removal of right sided l4-l5 pedicle screw instrumentation.(b)(6) 2014 the patient was discharged with the following discharge diagnoses: history of previous lumbar fusion, fusion appears well-healed on follow up ct scans, painful instrumentation, back pain.(b)(6) 2014 the patient presented for a post op visit.He felt that the muscle spasms in his lower back have been most bothersome for him and when the spasms flare-up, then his pain will also flare.(b)(6) 2014 the patient presented for postoperative visit.On (b)(6) 2004 the patient presented for an office visit.The following assessments were made : paroxysmal atrial fibrillation, possible holiday heart syndrome.Elevated ldl cholesterol.Review of systems: musculoskeletal: there is no history of muscle weakness or cramping.The patient has no peripheral neuropathy.Neurologic: there is no history of seizure disorder or epilepsy.There is no history of fainting or paralysis.There are no nervous disorders.Psychiatric: there is no history of depression or psychiatric illness.No mental health problems were elicited.On (b)(6) 2004 the patient presented to the office with complains of episodes of palpitations, chest tightness, heaviness and squeezing.On (b)(6) 2004 the patient underwent the nuclear imaging stress test.Impression: small fixed perfusion defect along the anterior wall without specific evidence of exercise induced myocardial ischemia.Hypokinetic septal wall motion.Abnormally low ejection fractions of 36% at rest and 50% at stress.On (b)(6) 2004 the patient presented for an office visit.On (b)(6) 2007, (b)(6) 2005, (b)(6) 2004 the patient underwent the following procedures: us echo transthoracic comp, us doppler echo colorflow, us doppler echocardiography.Impression: normal left ventricle function and ejection fraction.No cardiac chamber dilatation.Borderline left ventricular hypertrophy.Trivial mitral and tricuspid valvular insufficiency.On (b)(6) 2007 the patient underwent nuclear imaging stress test.Impression: normal myocardial perfusion spect images without evidence for pharmacological-induced ischemia.Normal left ventricular wall motion and thickening.Normal left ventricular ejection fraction of 52% post stress.(b)(6) 2007 the patient presented for cardiac checkup.On (b)(6) 2009 the patient presented for an office visit.On (b)(6) 2009 the patient presented to the office for a follow up.The patient underwent nuclear imaging stress test.Impression: normal myocardial perfusion spect images without evidence for pharmacological-induced ischemia.Normal left ventricular wall motion and thickening.Normal left ventricular ejection fraction of 47% post stress.On (b)(6) 2009 as per the patient exam history the patient underwent ct scan for lumbar spine.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.On (b)(6) 2009 as per the patient exam history the patient underwent ct scan lumbar spine.The patient also underwent fluoroscopy.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine on (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.On (b)(6) 2009 as per the patient exam history the patient underwent ct scan for lumbar spine.On (b)(6) 2009 as per the patient exam history the patient underwent fluoroscopy.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.On (b)(6) 2010 as per the patient exam history the patient underwent xrays for lumber spine.On (b)(6) 2010 as per the patient exam history the patient underwent mri for lumbar spine.On (b)(6) 2010 as per the patient exam history the patient underwent xrays for lumbar spine.On (b)(6) 2010 as per the patient exam history the patient underwent mri for lumbar spine.On (b)(6) 2011 as per the patient exam history the patient underwent mri for lumbar spine.On (b)(6) 2011, (b)(6) 2011, the patient presented with follow-up with complaints of back pain going down the leg, lower backache, left lower extremity pain and right lower extremity pain.He describes the pain as burning and sharp.Pain has been continues and varies in intensity.Review of systems revealed decreased rom, joint swelling, muscle cramps, muscle tenderness, back pain, joint pain, leg pain, muscle pain, stiffness, localized weakness, numbness, seizures, tingling, tremors, depression, mood swings, nervousness, tension.The patient underwent the procedure of toxicology screen and left selective nerve root block at l2-3, l3-4, l4-5.No patient complications.On (b)(6) 2012 as per the patient exam history the patient underwent mri for thoracic spine.The patient also underwent mri for lumbar spine and xrays for lumbar spine.On (b)(6) 2012 as per the patient exam history the patient underwent 3 phase bone scanning.The patient also underwent znmz blood flow test.On (b)(6) 2013 patient presented with pre-operative diagnosis of the lumbar radiculitis.Left selective nerve root block at l3-l4, l4-l5, l5-s1 no patient complications.On (b)(6) 2013 patient presented with pre-operative diagnosis of lumbar radiculitis.Right selective nerve root block at l3-l4, l4-l5, l5-s1.No patient complications.(b)(6) 2015 patient presented with chief complaint of lower backache.Musculoskeletal examination findings: "stuck" in back with crane 15 yrs ago sustaining fractures.Muscle aches, muscle cramps, tenderness, back pain, pins and needles.Gait: the patient has awkward gait, has slowed gait, has an unsteady gait.Limited spinal flexion with associated lbp, denies radiation of pain.Neurological examination findings: headache, sleep difficulty.Sensation is intact to light touch.Deep tendon reflexes are 2/4, equal and symmetric bilaterally in the upper and lower extremities.On (b)(6) 2015 as per patient exam history the patient underwent mri for mri of lumbar spine.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Current: age: (b)(6); height: (b)(6); weight: (b)(6).It was reported that on (b)(6) 2009 the patient underwent rhbmp-2/acs surgery and was also implanted with legacy system along with cage.Pre-op, the patient had back pain, numbness, leg pain and limited range of motion.From 2007 to present the patient diagnosed and treated for pain management.From 2009 to present patient diagnosed and treated for back pain.Post-op, the patient experienced additional weakness and the numbness that had spread to different areas such as the top of his foot and right thigh.The patient range of motion had gotten worse and experienced severe stiffness and pain in his back.The patient back pain and other symptoms were began to increase in (b)(6) 2009.The lower back pain and stiffness had spread to new locations.The patient was no longer able to walk or fish.The patient was not able to ride a motorcycle, 4-wheeler or use a push lawn mower.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that: on (b)(6) 2010: the patient presented with bilateral hand numbness.The patient underwent x-ray of cervical spine with flexion and extension lateral views.Conclusion: no acute cervical pathology is demonstrated.On (b)(6) 2010: the patient presented with a history of pain injection.The patient underwent noncontrast ct scan of head.Impression: no acute intracranial findings.On (b)(6) 2010: the patient presented with headache and leukocytosis.The patient underwent chest x-ray.Conclusion: ill-defined density is seen at the right lung and at the left lung apex.Infiltrates are not excluded.Mild cardiomegaly.On (b)(6) 2010: the patient presented with right lower lobe pneumonia.The patient underwent chest x-ray.Conclusion: segmental infiltrate is seen in the right lower lobe.On (b)(6) 2013: the patient underwent x-ray of left shoulder.Impression: unremarkable left shoulder.The patient underwent x-ray of left elbow.Impression: unremarkable left elbow.The patient underwent x-ray of left femur.Impression: unremarkable left femur.The patient underwent x-ray of left knee.Impression: unremarkable left knee.The patient underwent ct of chest without contrast.Impressions: no acute finding in the chest.No acute thoracic spine findings.The patient underwent ct of lumbar spine without contrast.Impressions: degenerative and post-operative changes.No acute findings appreciated.The patient underwent ct of head without contrast.Impression: no significant intracranial abnormality.The patient underwent ct of cervical spine without contrast.Impression: mild degenerative changes.No acute osseous abnormality.On an unknown date in (b)(6) 2007: the patient underwent disc surgery at the l4-5 level on the left side.On (b)(6) 2007: patient presented with following pre-op diagnosis: l4-5 lumbar disk herniation on the left.Patient underwent procedure: foraminotomy, discectomy l4-5 on the left.No patient complications were reported as a result of this event.On (b)(6) 2007: patient presented with mri of lumbar spine with and without contrast.Impressions: there is a transitional lumbosacral vertebra which is designated l6.Mild disc degeneration of l4-l5 with diffuse bulging of the discs into the neural foramina bilaterally and suggestion of annular tears.Mild disc degeneration of l5-l6.Previous left laminectomy at this level with a large amount of enhancing postoperative epidural fibrosis of the left side.No recurrent disc herniation.On same day, patient also underwent an x-ray of lumbar spine-four views.Impressions: there is a transitional lumbosacral vertebra which is designated l6.The left transverse process is sacralized.The l5-l6 level shows mild disc degeneration.Mild scoliosis and straightening of the normal lordosis.On (b)(6) 2007: patient presented for a follow-up visit and underwent physical examination.Impressions: recurrent biomechanical back pains after discectomy l4-5 on left on (b)(6) 2007.He has some epidural scar tissue, but no definite recurrent disc protrusion.On (b)(6) 2007: the patient presented for a follow-up visit and underwent a physical examination.Impressions: recurrent l4-5 disc on the left with super imposed epidural scar tissue.On (b)(6) 2008: patient underwent an mri scan which revealed epidural scar tissue at the level of his previous surgery on the left side, but no definite disc protrusion.There was mild segmental stenosis at the l4-5 level.Patient underwent multiple mri scans of the lumbosacral spine with and without iv gadolinium contrast.Impressions: mild circumferential bulging and facet degenerative changes at the l4 -5 level contribute to mild spinal stenosis without foraminal stenosis.The lumbosacral disc is labeled as the l6.There is a pseudoarthrosis between the l6 and s1 level on the left side.Such finding is best identified with ct and 3-d reconstructions.Postsurgical changes in the left paracentral location at the l5-6 level are not associated with spinal or foraminal recurrent disc herniation.On (b)(6) 2008: the patient underwent lumbar foraminotomy and discectomy at the l4-5 level on the left side.No patient complications was reported as a result of this event.On (b)(6) 2008: patient presented for a follow-up visit.Patient underwent a physical examination.Impressions: doing well after repeat discectomy l4-5 on left on (b)(6) 2008.On (b)(6) 2008: patient presented for a follow-up visit.Patient underwent physical examination.Impressions: recurrent left sided lumbago with some left sciatica, secondary to extensive epidural scar tissue l4-5 on left.On (b)(6) 2008: the patient underwent unknown radiology examination to re-explore l4-5 microdiscectomy.He also underwent x-rays of the lumbosacral spine due to microdiscectomy.Conclusion: probably discogenic disease at the l4-s1 disc levels.On same day, the patient also underwent a physical examination.Impressions: suspected l4-5 level as the pain generator.On (b)(6) 2008: the patient presented with left sided back and buttock pain.On (b)(6) 2010: patient presented with chief complaint of back pain <(>&<)> left leg pain.Review of neurological system: numbness, tingling, weakness, aura olfactory, aura visual, difficulty walking, focal weakness, hypersensitivity, tremors, recent seizure.Deep tendon reflexes are normal for the biceps, triceps, brachioradialis patellar and achilles regins bilaterally.Musculoskeletal examination findings: gait ans station examination reveals an antalgic gait which is moderate and that the patient ambulates with the use of an assistive device.On (b)(6) 2011, (b)(6) 2012 the patient presented with follow-up with complaints of back pain going down the leg, lower backache, left lower extremity pain and right lower extremity pain.He describes the pain as burning and sharp.Pain has been continues and varies in intensity.Review of systems revealed decreased rom, joint swelling, muscle cramps, muscle tenderness, back pain, joint pain, leg pain, muscle pain, stiffness, localized weakness, numbness, seizures, tingling, tremors, depression, mood swings, nervousness, tension.The patient underwent the procedure of toxicology screen and left selective nerve root block at l2-3, l3-4, l4-5.No patient complications.On (b)(6) 2012: the patient presented with chief complaint of back pain going down the leg, lower backache, left lower, left lower extremity pain and right lower extremity pain.Musculoskeletal examination: "stuck" in back crane 15 yrs ago sustaining fractures.Joint swelling, muscle cramps, muscle tenderness, back pain, joint pain, pain leg, muscle pain, stiffness.Neurological examination: localized weakness, numbness, tingling, tremors, seizures.On (b)(6) 2012: patient admitted with following diagnosis: left selective nerve root block l3-l4, l4-l5 and l5-s1 under fluoroscopy.No patient complications.On (b)(6) 2012, the patient presented for a followup with complaints of lower backache, left lower extremity pain and right lower extremity pain.He describes the pain as burning and sharp.Pain has been continues and varies in intensity.The patient had difficulty with large-scale movements such a bending and twisting.Review of systems revealed decreased rom, joint swelling, muscle cramps, muscle tenderness, back pain, joint pain, leg pain, muscle pain, stiffness, localized weakness, numbness, seizures, tingling, tremors, depression, mood swings, nervousness, tension.The patient underwent a procedure of saliva and urine toxicology screen.On (b)(6) 2013 patient presented with chief complaint of lower backache, left lower extremity pain and right lower extremity pain.He describes the pain as burning and sharp.Pain has been continues and varies in intensity.Musculoskeletal examination findings: back pain.Joint swelling, muscle cramps, muscle tenderness, back pain, joint pain, leg pain, muscle pain, stiffness.Patient has antalgic gait, is assisted by cane.Neurological examination findings: difficult walking, numbness, sleep difficulty, tingling.Motor testing limited by pain.Psychiatric examination findings: on examination of higher function, he is oriented to time place and person.Irritability, mood swings, poor sleep pattern, psychiatric or emotional difficulties.On (b)(6) 2013 patient presented with pre-operative diagnosis of the lumbar radiculitis.No patient complications.On (b)(6) 2013:.Patient presented with chief complaint of fall and down steps 2 times tonight.Neurological examination findings oriented x3.No motor deficit.No sensory deficit.Clinical impressions: fall, back pain: thoracic strain and lumbar strain, multiple superficial abrasion, neck strain, sprained left shoulder, left elbow, left knee, left knee sprain.On (b)(6) 2013 patient presented with chief complaint of lower backache, left lower extremity pain and right lower extremity pain.He describes the pain as burning and sharp.Pain has been continues and varies in intensity.Musculoskeletal examination findings: back pain.Joint swelling, muscle cramps, muscle tenderness, back pain, joint pain, leg pain, muscle pain, stiffness.Patient has antalgic gait, is assisted by cane.Neurological examination findings: difficult walking, numbness, sleep difficulty, tingling.Motor testing limited by pain.Psychiatric examination findings: on examination of higher function, he is oriented to time place and person.Irritability, mood swings, poor sleep pattern, psychiatric or emotional difficulties.On (b)(6) 2013 patient presented with pre-operative diagnosis of lumbar radiculitis.No patient complications.On (b)(6) 2013 and (b)(6) 2014 patient presented with chief complaint of lower backache, left lower extremity pain and right lower extremity pain.He describes the pain as burning and sharp.Pain has been continues and varies in intensity.Musculoskeletal examination findings: back pain.Joint swelling, muscle cramps, muscle tenderness, back pain, joint pain, leg pain, muscle pain, stiffness.Patient has antalgic gait, is assisted by cane.Neurological examination findings: difficult walking, numbness, sleep difficulty, tingling.Motor testing limited by pain.Psychiatric examination findings: on examination of higher function, he is oriented to time place and person.Irritability, mood swings, poor sleep pattern, psychiatric or emotional difficulties.On (b)(6) 2014 patient presented with pre-operative diagnosis of lumbar disc disease without myelopathy.No patient complications.On (b)(6) 2014 patient presented with chief complaint of lower backache, left lower extremity pain and right lower extremity pain.Pain has been present and ongoing for 7 years.Pain has been continues and varies in intensity.Musculoskeletal examination findings: back pain.Joint swelling, muscle cramps, muscle tenderness, back pain, joint pain, leg pain, muscle pain, stiffness.Patient has antalgic gait, is assisted by cane.Neurological examination findings: difficult walking, numbness, sleep difficulty, tingling.Motor testing limited by pain.On sensory examination, light touch sensation is patchy in distribution.Psychiatric examination findings: on examination of higher function, he is oriented to time place and person.Irritability, mood swings, poor sleep pattern, psychiatric or emotional difficulties.On (b)(6) 2014 patient presented with chief complaint of lower backache, left lower extremity pain and right lower extremity pain.Pain has been present and ongoing for 7 years.Pain has been continues and varies in intensity.Musculoskeletal examination findings: back pain.Joint swelling, muscle cramps, muscle tenderness, back pain, joint pain, leg pain, muscle pain, stiffness.Patient has antalgic gait, is assisted by cane.Neurological examination findings: difficult walking, numbness, sleep difficulty, tingling.Motor testing limited by pain.On sensory examination, light touch sensation is patchy in distribution.Psychiatric examination findings: on examination of higher function, he is oriented to time place and person.Irritability, mood swings, poor sleep pattern, psychiatric or emotional difficulties.On (b)(6) 2014 and (b)(6) 2015 patient presented with chief complaint of lower backache.Musculo skeletal examination findings: "stuck" in back with crane 15 yrs ago sustaining fractures.Muscle aches, muscle cramps, tenderness, back pain, pins and needles.Gait: the patient has awkward gait, has slowed gait, has an unsteady gait.Limited spinal flexion with associated lbp, denies radiation of pain.Neurological examination findings: headache, sleep difficulty.Sensation is intact to light touch.Deep tendon reflexes are 2/4, equal and symmetric bilaterally in the upper and lower extremities.On (b)(6) 2009 as per the patient exam history the patient underwent ct scan for lumbar spine.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.On (b)(6) 2009 as per the patient exam history the patient underwent ct scan lumbar spine.The patient also underwent fluoroscopy.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine on (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.On (b)(6) 2009 as per the patient exam history the patient underwent xrays for lumbar spine.On (b)(6) 2009 as per the patient exam history the patient underwent ct scan for lumbar spine.On (b)(6) /2009 as per the patient exam history the patient underwent fluoroscopy.On (b)(6) 2009 as per the billing records, patient used rhbmp-2/acs, rod-g, screw-f, screw pp.
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