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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Bronchitis (1752); Infarction, Cerebral (1771); Cyst(s) (1800); Dyspnea (1816); Edema (1820); Bone Fracture(s) (1870); Headache (1880); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Renal Failure (2041); Scarring (2061); Swelling (2091); Visual Disturbances (2140); Weakness (2145); Tingling (2171); Hypernatremia (2242); Stenosis (2263); Distress (2329); Depression (2361); Sore Throat (2396); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Nerve Proximity Nos (Not Otherwise Specified) (2647); Foreign Body In Patient (2687)
Event Type  Injury  
Event Description
It was reported that the patient underwent a spine fusion surgery at l4 to l5 using rhbmp-2/acs.Patient's post-operative period has been marked by increasing pain radiating from his lower back to his legs.
 
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
Add'l info.
 
Event Description
It was reported that on (b)(6) 2005: patient underwent mri of lumbar spine w/o contrast.(b)(6) 2014: the patient presented for follow- up with chief complaint of low back pain, s/p hemilaminectomy and facetectomy at l5-s1 with right cystectomy.Ros revealed: musculoskeletal: back pain, arthritis; psychiatric: depression; neurologic: tingling, memory loss.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2002 the patient presented with complaint of kidney stone, pain to right flank area, some burning and pain with urination.On (b)(6) 2003 the patient presented with pain between shoulder blades.On (b)(6) 2004 the patient presented with complaint of pain in lower back and swelling in left hand.On (b)(6) 2004 the patient presented with complaint of pain in right lower back, kidney region.Patient has history of stones.On (b)(6) 2004 the patient presented with complaint of right flank pain and underwent radiological tests.Impression: normal abdomen.On (b)(6) 2004 the patient presented with complaint of pain in middle back.On (b)(6) 2004 the patient presented with complaint of pain in upper and lower back.On (b)(6) 2005 the patient presented with complaint of hypertension, gout, lumbago, osteoarthritis.On (b)(6) 2005 the patient presented with pain in lower and upper back, odor to urine.On (b)(6) 2006 the patient presented to the office for re-evaluation of pain in neck back and shoulders.On (b)(6) 2006 the patient presented for re-evaluation of arthritis pain and pain in neck and spine.On (b)(6) 2007 the patient presented with complaint of pain between shoulder blades, chest congestion, cough, wheezing sore throat and hoarseness.On (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, (b)(6) 2011, (b)(6) 2012 as per billing record the patient was presented for office visit and underwent an injection procedure.On (b)(6) 2007 the patient presented with complaint of pain and swelling in right wrist , pain in left shoulder, hypertension, lumbago.On (b)(6) 2007 the patient presented with complaint of joint pain die to arthritis.On (b)(6) 2008 the patient presented with chief complaint of pain in feet, shoulders, right second toe swelling, red/blue in color, soreness and pain in spine area.On (b)(6) 2008 the patient presented for check up and complaints of edema in left foot and ankle, osteoarthritis and hyper tension.On (b)(6) 2008 the patient presented for checkup and complaints of hypertension and osteoarthritis.On (b)(6) 2009 the patient presented for re-evaluation of arthritis , back pain, hypertension and complaint of right hand pain.On (b)(6) 2009 the patient presented to the office for checkup, refill on meds, hypertension, osteoarthritis, painful knot on palm of rt.Hand, pain in rt.Middle and ring finger.On (b)(6) 2010 the patient presented with complaints of pain in right hand and fingers, osteoarthritis and lumbago.On (b)(6) 2010 the patient presented for check up and chief complaint of gout, osteoarthritis, lumbago, hypertension and difficulty closing right index finger.On (b)(6) 2010 the patient presented with chief complaint of degenerative disk disease and hypertension.On (b)(6) 2011 the patient presented to the office to re-evaluate hypertension, disk joint disease and pain.On (b)(6) 2012 the patient underwent x-ray of lumbosacral spine due to lumbar spondylosis and lumbar degenerative disk disease.Impression: l.Postoperative changes from prior l4-l5 fusion.The hardware is stable in position.The fusion appears more solid on today's exam; no acute osseous abnormality is demonstrated; mild degenerative endplate changes within the lumbar spine which is not significantly changed from the prior exam.On (b)(6) 2012: the patient presented with back pain, arthritis pain.On (b)(6) 2013, (b)(6) 2014, (b)(6) 2015 as per billing record the patient was presented for office visit.On (b)(6) 2013 the patient presented for follow up on chronic back pain.On (b)(6) 2013 the patient presented with chief complaint of lesions to the face.On (b)(6) 2013 the patient presented for an office visit to re-evaluate multiple health problems.On (b)(6) 2013 the patient presented for follow up visit.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Per medical records it was reported that on (b)(6) 2006: the patient presented with chief complaint of low back pain.The patient underwent x-rays of lumbar spine.Impression: very mild degree of curvature of the lumbar spine with convexity toward the right in the ap view which is questionable for a mild degree of rotoscoliosis although this may simply be positional; otherwise negative exam.The patient underwent mri of lumbar spine due to low back pain.Impression: mild degree of spinal stenosis at l4-l5 level secondary to posterior element configuration.Mild hypertrophic degenerative joint disease in the posterior facet joint and mild hypertrophy of the ligamentum flavum.On (b)(6) 2007: the patient presented with low back pain.The patient underwent x-ray of lumbosacral spine.Impression: no acute fracture; status post posterior fusion at l4-l5 with left sided transpedicular screw and plate apparatus with mild retrolisthesis at the level of fusion.Status post anterior fusion at l4-l5 with interbody fixation apparatus; mild endplate osteophyte formation without significant spondylotic changes.On (b)(6) 2008 patient presented for follow-up due to arthritis and reduced back pain.On (b)(6) 2008 patient presented for follow-up due to arthritis, severe pain in wrist, ankle.On (b)(6) 2009 patient presented due to arthritis pain, deep pain.On (b)(6) 2009 patient presented for x-ray in right hand.On (b)(6) 2009 patient presented due to pain and stiffness to right hand, increase pain and stiffness.On (b)(6) 2010 patient presented due to pain and swelling.On (b)(6) 2011 patient presented due to increased pain, edema, right hand- chronic low back pain.On (b)(6) 2011 patient continued with pain in right hand and pain to the low back after falling from bulldozer.On (b)(6) 2011 patient presented due to increased arthritis pain.On (b)(6) 2011 patient presented due to increased pain to low back after having accident.On (b)(6) 2011 patient presented with chronic arthritis pain and back pain.On (b)(6) 2011 patient presented due to back pain.On (b)(6) 2012 patient presented for follow-up due to arthritis pain, high bp, (b)(6) 2012: patient also presented with pain in back and hands.On (b)(6) 2013 patient presented due to hypertension/headache, elev bp/headache (b)(6) 2015, the patient presented for radiological examination.On (b)(6) 2015 patient presented due to foreign body in left ear, lt ear complaints.On (b)(6) 15 , the patient presented for bilateral s1 joint injection under fluoroscopy (b)(6) 2015 patient underwent ct head without contrast.Impression: no change with no evidence of acute pathology; stable arachnoid cyst adjacent to the left frontal and parietal lobes.On (b)(6) 2015, the patient presented for office visit and underwent few evaluations.On (b)(6) 2015 , the patient presented for cmp, cbc, ecg (b)(6) 2015, the patient presented with unsp inflammatory spondylopathy, and spinal instabilities in lumbosacral region.On (b)(6) 2015, the patient presented for follow up.On (b)(6) 2015, the patient presented for office visit for fusion of sacroiliac joint using screw system with one 40mm screw, two 35 mm s crews, one 30 mm screw, dbm 5ml.On (b)(6) 2015, the patient presented with pre-op diagnosis : prior lumbar fusion @ l4-5.; residual or recurrent spinal stenosis, l4-5.Primary spinal stenosis , l5-s1.; lumbar radiculopathy ; neurogenic claudication.; l5-s1 grade ii spondylolisthesis with spinal instability.Per op notes, the patient underwent following procedures: instrumented posteolateral fusion l5-s1; posterior lumbar interbody fusion l5-s1; revision posterior bilateral decompression l4; primary bilateral decompression at l5, s1; removal of segmental spinal hardware l4-5.Exploration of spinal fusion l4-5.Placement of bioomechanical fixation device l5-s1.Placement of bonegraft for fusion l5-s1.Bone marrow aspiration left posterior iliac crest.Repair of intraoperative durotomy with primary repair.Intraoperative neural monitoring system.Per notes, the procedure was performed using using four pedicle screws , four locking screws, one peek biomechanical cage , 5ml of osteocel pro, 15ml of cancellous bone graft, 5ml of dbm, autograft for local harvest.On (b)(6) 15, the patient presented for follow up.On (b)(6) 2014 the patient presented with complaint of low back pain , lumbar radiculitis , ddd , spondylolisthesis, stenosis.On (b)(6) 2014 <(>&<)> (b)(6) 2015 the patient presented with preop diagnosis : lbp, lumbar radiculopathy, ddd, bulging disk , s/p lumbar fusion , post lumbar laminectomy syndromeand underwent following procedure : l5-s1 intralaminar es1 ( x 3) (b)(6) 2015, the patient presented with chief complaint of low back pain , hip pain and underwent evaluation of his lumbar spine.On (b)(6) 2015, the patient presented for radiological examination (b)(6) 2015, the patient presented for pre-operative education regarding the procedure.
 
Manufacturer Narrative
(b)(6).(b)(4).
 
Event Description
It was reported that on (b)(6) 2006: the patient resented with chief complaint of low back pain.On (b)(6) 2006: the patient underwent x-ray of lumbar spine w/flex <(>&<)> evt.Impression: very mild degree of curvature of the lumbar spine with convexity towards the right in the ap view which is questionable for a mild degree pf rotoscoliosis although this may simply be positional.On (b)(6) 2006: the patient underwent mri, lumbar spine w/o contrast.Impression: 1.Mild degree of spinal stenosis at the l4-l5 level secondary to posterior element configuration , mild hypertrophic degenerative joint disease in the posterior facet joint and mild h ypertrophy of the ligamentum flavum (b)(6) 2007, (b)(6) 2006: the patient presented with chief complaint of low back pain.On (b)(6) 2007: the patient underwent hemogram.On (b)(6) 2007: the patient underwent ct: lumbar spine w/o contrast.Impression: postoperative change was seen with left posterior fusion of l4-l5 with pedicle screws and stabilization bar.No evidence of loosening or breakage of the hardware was seen.Interbody fusion device also seen in place.On (b)(6) 2007: the patient presented with chief compliant of back pain.The patient underwent examination.Musculoskeletal: examination of spine is normal.Lumbar flexion and extension is normal.Straight leg raising is normal bilaterally.Neurological/psych: reflexes are intact and symmetrical station/gait is normal.The patient diagnosed with anterolisthesis l4-5, stenosis l4-5, segmental instability l4-5, lumbar disk degeneration and chronic low back pain.The patient underwent 1.Minimally invasive transforaminal decompression and microdiskectomy, l4-l5 on the left2.Interbody fusion, l4-l5.3.Placement of interbody device at l4-5.4.Nonsegmental fixation, l4-5 left.Other implants that were used in this surgery were: globus 17mm peek plif, pedicle screws and plates.Per-op notes: the patient was brought to operating room and turned to prone position.Exposed the neutral foraminal.Used a high speed drill to remove the superior facet of l5 and a good portion of pars and inferior facet of l5 exposing the left side of the canal.A little bone above and below.The surgeon was being very carefully not to remove any more bone than necessary because this was already a very tall disc space.Then, while surgeon was cleaning out the disk space, a kit of bmp-2 was prepared and a strip of bmp-soaked collagen was placed in a 16x25mm novel device.So we removed the novel device and turned attention to getting another device which we knew was somewhat larger, so we used a globus plif interbody device.Surgeon took the remaining 1x2 inch piece of bmp-soaked collagen, which surgeon had taken out of the novel device.Surgeon placed the fresh 1x2 inch piece of bmp-soaked collagen device into the globus device before inserted.Surgeon took final ap and lateral fluoroscopic images which looked good.The patient underwent ct of lumbar spine w/o contrast.Impression: postoperative change is seen with left posterior fusion of l4-l5 with pedicle screws and stabilization bar.No evidence of loosening or breakage of the hardware is seen.Interbody fusion device also seen in place.On (b)(6) 2007: the patient underwent spinal localization (b)(6) 2007: the patient presented with bilateral and hip pain.On (b)(6) 2007: the patient presented with low back pain the patient underwent lumbosacral spine x-ray.Impression: no acute fracture.Status post posterior fusion at l4-l5 with left-sided transpedicular screw and plate apparatus with mild retrolisthesis at the level of fusion.Mild endplate osteophyte formation without significant spondylotic changes.On (b)(6) 2009: the patient presented with arthritis and chronic pain.On (b)(6) 2010, (b)(6) 2009: the patient presented with arthritis and hyperuricernia (b)(6) 2011, (b)(6) 2010, (b)(6) 2009: the patient presented with arthritis.On (b)(6) 2011, (b)(6) 2008: the patient presented with back pain and arthritis.On (b)(6) 2011: the patient presented with arthritis, swelling and pain.On (b)(6) 2011: the patient presented with arthritis and hyperuricernia.On (b)(6) 2011: the patient presented with arthritis.On (b)(6) 2012: the patient presented with arthritis and increased bp.On (b)(6) 2012, (b)(6) 2011: the patient presented with back pain, arthritis.On (b)(6) 2012: the patient presented with back pain, hyperuricernia and arthritis.On (b)(6) 2012: the patient underwent mri, lumbar spine w/o contrast.Impression: interval surgery with l4-l5 fusion with resulting signal artifact obscuring the left neural foramen.Scattered degenerative change without canal stenosis.Mild right l4-l5 and bilaterally l5-s1 neural foraminal stenosis similar to the prior study.Remaining neural foramina are patent.On (b)(6) 2012: the patient presented with back pain.On (b)(6) 2012: the patient presented with back pain, hip pain and difficulty in walking.On (b)(6) 2012: the patient presented with low back pain that radiate to legs and tingling.On (b)(6) 2013: the patient presented with back pain and radiculopathy.On (b)(6) 2013: the patient presented with back and right leg pain.Ros revealed: musculoskeletal: joint pain, back pain, stiffness, muscle weakness, arthritis, gout, loss of strength, muscles aches.Neurologic: difficulty with concentration, poor balance, disturbance in coordination, numbness, falling down, tingling, visual disturbances, weakness, memory loss.Psychiatric: depression.On (b)(6) 2013: the patient underwent mri lumbar spine with/without iv contrast.Impression: previous fusion in and laminectomy at l4/l5 with a small amount of epidural and perineural granulation tissue.There is degenerative disc disease and arthritis change which produce neuroforaminal narrowing left-sided nerve root impingement at l4/l5 and bilateral nerve root impingement at l5/s1, mild annular disc bulge and arthritis change at l3/l4.The patient underwent us, extremity venous doppler right.Impression: negative right leg venous ultrasound.On (b)(6) 2013: the patient presented with chief complaint of lumbar stenosis with mri lumbar, dvt study and after pt.Ros revealed: mu sculoskeletal: back pain, arthritis.Neurologic: difficulty with concentration, poor balance, numbness, falling down, tingling, memory loss.Psychiatric: complaint of sense of great danger, depression.On (b)(6) 2013: the patient underwent x-ray, spinal localization.The patient diagnosed with preoperative facet joint cyst facet arthropathy right side l5-s1, with severe nerve root compression.Prior fusion transforaminal lumbar interbody fusion (tlif), l4-5 via the left side.The patient underwent left subtotal facetectomy with decompression and foraminotomy, l5-s1 right.On (b)(6) 2013: the patient presented with chief complaint of hemilaminectomy and facetectomy at l5-s1 with right cystectomy.Ros revealed: ros revealed: musculoskeletal: back pain, arthritis.Neurologic: difficulty with concentration, poor balance, numbness, falling down, tingling, memory loss.Psychiatric: complaint of sense of great danger, depression.On (b)(6) 2013: the patient underwent mri head without iv contrast.Impression: lef41t cerebral perirolandic cystic encephalomalacia most consistent with a remote area of infarction.No acute ischemia, acute intracranial blood breakdown products or hydrocephalus.Mild right maxillary sinus mucosal thickening without acute air-fluid levels.The patient underwent ct, head without iv contrast.Impression: area of hypodensity seen left superior posterior frontoparietal region primary within the cortex and immediate subcortical region and is felt consistent with an area of infarction most likely subacute to old.The patient underwent mri head without iv contrast.Impression: left cerebral perirolandic cystic encephalomalacia most consistent with a remote area of infarction.No acute ischemia, acute intracranial blood breakdown products or hydrocephalus.Mild right maxillary sinus mucosal thickening without acute air-fluid levels.The patient underwent x-ray, chest portable.Impression: mild decreased lung volumes bilaterally without evidence of acute parenchymal or pleural pathology.2, very mild cardiomegaly.The patient underwent us, renal.Impression: unremarkable renal ultrasoung.2.Urinary bladder wall measure up to 4 mm in thickness.Again this may be seen secondary to non-distention or in cystitis.The patient underwent us, carotid artery.Impression: mild stenosis on the proximal right ica with estimated diameter reduction of loss than 40%.No significant stenosis in the proximal left ica.Antegrade vertebral artery flow bilaterally.On (b)(6) 2013: the patient underwent ct, head without iv contrast.Impression: no acute intracranial finding or significant change compared to prior mri examination.On (b)(6) 2013: the patient underwent x-ray, chest portable.Impression: no active disease, consolidation, pleural effusion, pneumothorax.Mild cardiomegaly normal pulmonary vessels.On (b)(6) 2013: the patient underwent mri head without iv contrast.Impression: stable appearance unchanged from the prior study of (b)(6) 2013 with a benign stable extra axial cystic lesion overlying the left parietal lobe.On (b)(6) 2013: the patient underwent x-ray videofluoroscopy swallow/speech.Impression: normal study.(b)(6) 2013: the patient presented with chronic back pain and hip pain.On (b)(6) 2013, (b)(6) 2011: the patient presented with chronic back pain.On (b)(6) 2013: the patient underwent mri lumbar spine.Impression: 1.Small residual or recurrent synovial cyst off the right l5-s1 facet without significant lateral recess stenosis or nerve root compression following laminectomy.2.Intact posterior surgical fusion on the left at l4-l5 in anatomic alignment.3.Chronic degenerative disc and facet disease primary resulting in foraminal stenosis.On (b)(6) 2013: the patient presented with lower back pain (b)(6) 2013: the patient underwent us, extremity venous doppler bilateral.Impression: venous sonogram within normal limits.On (b)(6) 2013: the patient presented with chronic back pain and arthritis.On (b)(6) 2014: the patient presented for follow- up with chief complaint of low back pain, s/p hemilaminectomy and facetectomy at l5-s1 with right cystectomy.The patient underwent x-ray, c-arm vma.Impression: 4 mm anterolisthesis of l5 on s1 this reduces in the supine resting position.No abnormal motion at the fused l4-l5 level (b)(6) 2014: the patient underwent ct, spine, lumbar without iv contrast.Impression: intact intervertebral and left posterior un ilateral surgical fusion l4-l5 in anatomic alignment with partial osseous fusion posteriorly on the left.Left l4-l5 and right l5-s1 foraminal stenosis with decreased perineural fat.Remote l5 facet fracture with progressive degenerative facet disease and th ickening of the right ligamentum flavum with a small facet.Multilevel disc bulging.The patient underwent x-ray, lumbar spine, flex and ext only.Impression: 4 mm anterolisthesis of l5 on s1 this reduces in the supine resting position.No abnormal motion at the fused l4-l5 level.The patient underwent x-ray, c arm vma impression: 4 mm anterolisthesis of l5 on s1 this reduces in the supine resting position.No abnormal motion at the fused l4-l5 level.The patient underwent nuc med, bone scan.Impression: no significant increased radiopharmaceutical accumulation to suggest acute fracture, infection, inflammation or osseous metastatic disease.On (b)(6) 2014: the patient presented with chronic back pain that radiates down to leg.On (b)(6) 2014: the patient presented for follow-up with chief complaint of low back pain and leg pain.On (b)(6) 2014: the patient underwent ct, spine lumbar with iv contrast.Impression: grade 1 spondylolisthesis, disc bulge, facet arthropathy contributes to right lateral recess stenosis with partial effacement of the right s1 nerve root.Disc bulge and facet disease contributes to mild foraminal stenosis.2.Spinal canal and foraminal patent otherwise.The patient underwent xr, myelogram lumbar.Impression: 1.Lumbar myelogram performed without complication.Left posterior fusion l4-l5.Orthopedic hardware intact.On (b)(6) 2014: the patient presented for follow up with chief complaint of myelogram for bilateral leg pain and low back pain.On (b)(6) 2014: the patient diagnosed with pre-operative.Adjacent level disease to lumbar fusion at l4-5.Bilateral facet arthropathy and foraminal stenosis.The patient underwent lumbar decompression with bilateral medial facetectomy, foraminotomy.Ros revealed: neuro musculoskeletal: pinched nerve in back, arthritis, back problem, bilateral leg pain, mini strokes.On (b)(6) 2014: the patient underwent xr, spinal localization.On (b)(6) 2014: the patient presented for follow up with chief complaint of post of lt l5/s1 lumbar decompression.On (b)(6) 2014: the patient presented with chronic back pain, leg pain, cough and chronic bronchitis.On (b)(6) 2014: the patient presented with chief complaint of back and right leg pain.Ros revealed: musculoskeletal: joint pain, back pain, stiffness, muscles weakness, arthritis, gout, loss of strength, muscle aches.Neurologic: difficulty with concentration, poor balance, disturbance in coordination, numbness, falling down, tingling, visual disturbances, weakness, memory loss.Psychiatric: depression.On (b)(6) 2014: the patient presented with chronic back pain and leg pain.On (b)(6) 2014: the patient presented with low back pain and depression.On (b)(6) 2014: the patient presented with chronic back pain.On (b)(6) 2014: the patient presented with arthritis, chronic back pain and bp.On (b)(6) 2014: the patient presented with arthritis, chronic back pain that radiated down legs.On (b)(6) 2014: the patient underwent ct, spine lumbar with iv contrast.Impression: grade 1 spondylolisthesis, disc bulge facet arthropathy contributes to right lateral recess stenosis with partial effacement of the right s1 nerve root.Disc bulge and facet disease contributes to mild foraminal stenosis.Spinal canal and foramina patent otherwise.On (b)(6) 2014: the patient presented with low back pain that radiates down to legs and failed back syndrome.On (b)(6) 2014: the patient presented with back pain, arthritis and knee pain.On (b)(6) 2014: the patient presented with back pain, leg pain, arthritis and knee pain.On (b)(6) 2014: the patient presented with back pain and leg pain.On (b)(6) 2014: the patient presented with back pain.On (b)(6) 2015: the patient presented with pain.On (b)(6) 2015: the patient presented with complaint of chronic back pain and sinusitis.On an unknown date in (b)(6)2015, the patient underwent hardware removal surgery.On (b)(6) 2015: the patient presented with low back pain and leg pain.On (b)(6) 2015: the patient presented with chief complaint nmmc-also needs repeat labs for renal failure.Ros revealed: musculoskeletal: pain to back and legs, osteoarthritis, gout, lumbago, limitation of motion of thoracic and lumbar spine.Neurological: cranial nerves ㇒ossly intact.The patient presented with chief complaint of checkup, refill on meds, gout, osteoarthritis, lumbago, and hypertension.Since the rhbmp-2/acs surgery, the patient has been suffering from the following injuries: two revision surgeries including the one to remove hardware in (b)(6) 2015.The symptoms also includes: severe back pain that radiates into lower extremities and both legs.The patient also has difficulty standing or sitting for long periods of time.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on, (b)(6) 2014 the patient presented with complaint of low back pain, lumbar radiculitis, ddd, spondylolisthesis, stenosis.The patient was administered epidural steroid injection.Preoperative diagnosis: low back pain, lumbar radiculopathy, lumbar degenerative disc disease, lumbar bulging disc, lumbar facet arthropathy, status post lumbar fusion.The patient also underwent x rays of the lumbosacral series.On (b)(6) 2015, the patient presented with chief complaint of low back pain, hip pain and underwent evaluation of his lumbar spine.The patient also underwent mri of the lumbar spine.On (b)(6) 2015 the patient was presented for office visit.Assessments: spondylolisthesis stenosis lumbar radiculopathy.The patient also underwent x rays of the lumbar spine.Impressions: intact intervertebral and left posterior unilateral surgical fusion l4-5 with anatomic alignment with partial osseous fusion posteriorly on the left.Left l4-5 and right l5-s1 foraminal stenosis with decreased peroneal fat.Remote l4 facet fracture with progressive degenerative facet disease and thickening of the right ligamentum flavum with small facet osteophyte, resulting in right lateral recess stenosis.Multilevel disc bulging.Prior lumbar fusion l4-5 with a grade 1 spondylolisthesis l5-s1 with severe degenerative disc disease and foraminal stenosis causing severe low back pain and radiculopathy.On (b)(6) 2015 the patient underwent mri of the lumbar spine.Impressions: status post tlif at the l4-5 level.There is 5mm of anterolisthesis of l5 on s1 with some right neuroforaminal narrowing.Epidural scar at the l5-s1 level as described and to a lesser degree on the left at the l4-5 level.Bilateral facet joint fluid at the l5-s1 level which may be associated with some instability.Spondylosis at the l3-4 level with mild associated acquired canal stenosis.On (b)(6) 2015 the patient underwent x rays of the chest.Impressions: no active disease.On (b)(6) 2015: the patient presented with low back pain and leg pain.The patient was reviewed with exos spine bracing system.Assessments: lumbar foraminal stenosis, lumbar radiculopathy, spondylolisthesis.On (b)(6) 2015 the patient underwent cbc, cmp, ekg and chest x rays.On (b)(6) 2015, the patient presented for follow up.The also underwent x rays of the lumbar spine.Assessments: spondylolisthesis, stenosis and lumbar radiculopathy.On (b)(6) 2015, the patient presented for radiological examination.The also underwent x rays of the lumbar spine.The patient was presented for office visit for post op follow up.Assessments: spondylolisthesis, stenosis, lumbar radiculopathy.On (b)(6) 2015 , the patient presented for bilateral si joint injection under fluoroscopy.Preoperative diagnosis: low back pain, lumbar radiculopathy, lumbar degenerative disc disease, status post lumbar fusion, bilateral si joint pain, sacroilitis.On (b)(6) 2015, the patient underwent repeat caudal epidural steroid injection.Preoperative diagnosis: low back pain, lumbar radiculopathy, lumbar degenerative disc disease, status post lumbar fusion, bilateral si joint pain, sacroilitis, lumbar bulging disc, lumbar facet arthropathy.(b)(6) 2015 the patient underwent bilateral si joint injection under fluoroscopy.Preoperative diagnosis: low back pain, lumbar radiculopathy, lumbar degenerative disc disease, status post lumbar fusion, bilateral si joint pain, sacroilitis, lumbar bulging disc, lumbar facet arthropathy.On (b)(6) 2015, the patient presented for office visit and underwent few evaluations.The also underwent x rays of the lumbar spine.Assessments: spondylolisthesis, stenosis, lumbar radiculopathy, si sacroiliac joint dysfunction, si sacroiliac pain, si joint arthritis.Assessments: status post lumbar fusion with development of bilateral sacroilitis, si joint pain secondary to end-stage bilateral si joint arthritis.On (b)(6) 2015, the patient presented for cmp, cbc, ecg, ekg and chest x rays.On (b)(6) 2015 the patient was presented for 18 days post op follow up of bilateral sacroiliac joint fusion.Assessments: spondylolisthesis, stenosis, lumbar radiculopathy, severe chronic bilateral sacroiliac joint dysfunction unresponsive to treatment, severe chronic bilateral sacroiliac pain worsening, severe bilateral sacroiliac joint arthritis worsening.On (b)(6) 2015 the patient was presented for office visit with low back pain bilaterally around the lumbosacral junction.Assessments: status post lumbar fusion with development of bilateral sacroilitis, si joint dysfunction, severe si joint pain secondary to end stage bilateral si joint arthritis.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on, (b)(6) 2005: patient presented with complaint of back pain and underwent mri of lumbar spine w/o contrast.Impression: there is mild disk desiccation and posterior disk bulges and facet and ligamentum flavum hypertrophic changes within the lumbar spine, the lower thoracic spine, and more prominent at l4-5 with relative mild canal stenosis and mild left lateral recess and foraminal encroachment and mild bilateral foraminal encroachment at l5-s1 as described above.On (b)(6) 2010: patient with a several year history of recurrent right hand pain, underwent electromyography and nerve conduction studies.Conclusion: needle emg of the listed muscles revealed no abnormalities.There is no evidence of carpal tunnel syndrome at present or other peripheral neuropathology to account for the patient¿s symptoms.Musculoskeletal factors are more likely responsible for his symptoms.On (b)(6) 2010: patient presented for an office visit.On (b)(6) 2012: patient presented with chief complaint of altered mental status and back pain.On (b)(6) 2013 the patient was presented for office visit with hypertension, back pain that radiates to his leg on the right.Diagnosis : acute renal failure; hypertension; hypernatremia; status post recent fall with bruising and swelling in the area of the right eye; cva; hard of hearing; chronic back pain; status post cholecystectomy; status post back surgery; status post hernia surgery; history of kidney stone removal; status post right hand surgery; arthritis; gout; history of basal skin carcinoma; anemia; mild proteinuria.On (b)(6) 2013 the patient was presented for office visit.Diagnosis: acute renal failure; hypertension; hypernatremia; status post recent fall with bruising and swelling in the area of the right eye; cva; hard of hearing; chronic back pain; status post cholecystectomy; status post back surgery; status post hernia surgery; history of kidney stone removal; status post right hand surgery; arthritis; gout; history of basal skin carcinoma; anemia; mild proteinuria.On (b)(6) 2013: the patient presented with complaints of worsened bilateral pain to lower legs and was diagnosed with edema.Patient underwent electrocardiogram, ultra-sound, extremity venous doppler bilateral.Impression: venous sonogram within normal limits.On (b)(6) 2014 the patient was presented for office visit.Diagnosis: acute renal failure; hypertension; hypernatremia; status post recent fall with bruising and swelling in the area of the right eye; cva; hard of hearing; chronic back pain; status post cholecystectomy; status post back surgery; status post hernia surgery; history of kidney stone removal; status post right hand surgery; arthritis; gout; history of basal skin carcinoma; anemia; mild proteinuria.On (b)(6) 2014: patient presented with complaints of headache, and hypertension.On (b)(6) 2015 the patient presented with preop diagnosis : low back pain, lumbar radiculopathy, ddd, bulging disk , s/p lumbar fusion , post lumbar laminectomy syndrome and underwent following procedure: left l4-5, l5-s1 transforaminal steroid injection.On (b)(6) 2015 the patient presented with preop diagnosis : low back pain, lumbar radiculopathy, ddd, bulging disk , s/p lumbar fusion , post lumbar laminectomy syndrome and underwent following procedure: lumbar epidural block l5-s1.On (b)(6) 2015 the patient was presented for office visit.Diagnosis: acute renal failure; hypertension; hypernatremia; status post recent fall with bruising and swelling in the area of the right eye; cva; hard of hearing; chronic back pain; status post cholecystectomy; status post back surgery; status post hernia surgery; history of kidney stone removal; status post right hand surgery; arthritis; gout; history of basal skin carcinoma; anemia; mild proteinuria.On (b)(6) 2015: the patient presented with preop diagnosis : low back pain, lumbar radiculopathy, ddd, bulging disk , s/p lumbar fusion , bilateral si joint pain, sacroilitis and underwent following procedure: bilateral sacroiliac joint steroid injection.On (b)(6) 2015: the patient presented with preop diagnosis : low back pain, lumbar radiculopathy, ddd, bulging disk , s/p lumbar fusion , lumbar facet arthropathy, lumbar stenosis, bilateral si joint pain, sacroilitis and underwent following procedure: caudal epidural steroid injection.On (b)(6) 2015: patient presented for an office visit and was diagnosed pre-operatively with sacroilitis.Patient was provided sacroiliac steroid injection.No complications were reported in the procedure.On (b)(6) 2015: patient presented for follow up on low back pain, sacro-iliac pain, pain management.Patient also reviewed for the following problems: opioid dependence, chronic pain, sacroiliac joint inflamed, osteoarthritis of spinal facet joint, lumbago-sciatica due to displacement of lumbar intervertebral disc, degeneration of intervertebral disc, lumbar-post laminectomy syndrome, spinal stenosis of lumbar region, fracture of vertebral column.Patient¿s review of systems (ros), revealed: back pain.Patient¿s physical examination revealed: joints, bones, muscles: limited range of motion.On (b)(6) 2015 the patient was presented for office visit with incomplete recovery from acute renal failure.Diagnosis: acute renal failure; hypertension; hypernatremia; status post recent fall with bruising and swelling in the area of the right eye; cva; hard of hearing; chronic back pain; status post cholecystectomy; status post back surgery; status post hernia surgery; history of kidney stone removal; status post right hand surgery; arthritis; gout; history of basal skin carcinoma; anemia; mild proteinuria.On (b)(6) 2015: patient presented with low back pain bilaterally around the lumbosacral junction.Patient underwent x-rays of his lumbar spine.Impression: bilateral sacroilitis, s1 joint dysfunction, severe si joint pain secondary to end stage bilateral si joint arthritis.On (b)(6) 2015: patient presented with preop diagnoses: bilateral sacroiliac joint arthritis, bilateral sacroiliac joint dysfunction bilateral sacroilitis severe.Procedure: bilateral percutaneous sacroiliac joint bone fusion with instrumentation.On (b)(6) 2015: patient underwent ct head without iv contrast for ams.Impression: ¿persistent area of hypodensity left superior posterior frontoparietal region consistent with arachnoid cyst as has been previously documented with mri scan.There are no acute abnormalities.¿ patient also underwent chest x-ray.Impression: single frontal image of the chest was performed.There are small lung volumes which accentuate cardiac contours and pulmonary vasculature.Allowing for this, no definite focal consolidation, pneumothorax, or pleural effusion is seen.Cardiac silhouette and mediastinal contours are felt to be within normal limits.On (b)(6) 2015: patient was admitted and diagnosed with altered mental status and metabolic encephalopathy.Patient underwent various physical examinations, the assessments for which are the following: hld (hyperlipidemia), htn (hypertension), lumbago, obesity (bmi (b)(6)).Patient underwent mri head without iv contrast for aphasia.Findings: there is no diffusion abnormality.Impression: negative for acute infarction.Patient also underwent routine eeg using modified 10/20 electrode placement system.Impression: ¿the patient became agitated and pulled off his leads during the recording.However, background activity showed a moderately severe diffuse encephalopathy with the presence of triphasic waves suggestive of metabolic etiology.No clear epileptiform activity was seen.¿ impression: delirium related to initiation/adverse reactions to morphine administration; hypokalemia; hypernatremia; chronic kidney disease stage iii; chronic back pain; bilateral presbycusis (b)(6) 2015: patient was discharged from the facility.On (b)(6) 2015, (b)(6) 2016: patient presented with chief complaint of low back pain, and also for pain medication refill and pain management.Patient was also reviewed for the following problems: opioid dependence, chronic pain, sacroiliac joint inflamed, osteoarthritis of spinal facet joint, lumbago-sciatica due to displacement of lumbar intervertebral disc, degeneration of intervertebral disc, lumbar-post laminectomy syndrome, spinal stenosis of lumbar region, fracture of vertebral column.Patient¿s review of systems (ros), revealed: sleep apnea, back pain.Patient¿s physical examination revealed: joints, bones, muscles: limited range of motion.
 
Event Description
It was reported that on (b)(6) 2015 patient underwent x-ray of lumbar spine ap, due to l5-s1 plif, bilateral decompression, l4-l5 ¿roh¿.On (b)(6) 2015 : patient underwent x-ray pelvis, 1 or 2 views.On (b)(6) 2016: patient presented for office visit.Assessment: severe chronic bilateral si joint dysfunction,pain, severe bilateral si joint arthritis.Patient underwent x-ray pelvis, 1 or 2 views.The implants are well positioned.There appears to be fusion mass incorporating across the si joints around the screws.There are no signs of hardware loosening.Patient complains of insomnia at night.On (b)(6) 2015, (b)(6) 2016:patient presented for office visit.
 
Event Description
It was reported that on (b)(6) 1987: patient presented with complaint of chest pain was admitted to the hospital.The patient was diagnosed of chest pain and upper abdominal pain.On (b)(6) 1987: patient also underwent a radiology exam due to chest and epigastric pain.Impressions: small intermittent hiatal hernia with not other abnormalities noted on upper gi series.On same day patient also underwent an ultrasound examination of the gallbladder.Impressions: solitary gallstone seen.On (b)(6) 1987: patient was discharged with following diagnosis: cholelithiasis.Hiatus hernia, intermittent.On (b)(6) 1990: patient presented with an ultrasound exam of the gallbladder and x-ray due to abdominal pain.Impressions: solitary gallstone, unchanged.Patient also underwent an esophagogastroduodenoscopy and esophageal dilatation.Impressions: esophagitis.Hiatal hernia.Lower esophageal ring.Gastritis.On an unknown date, patient presented for a follow-up with complaint of back pain.Patient underwent a physical examination.Impressions: upper thoracic pain, etiology undetermined.On (b)(6) 1991: patient was admitted as was presented with following diagnosis: infection of the right finger.Catfish fin injury with secondary infection and cellulitis of the right middle finger.Impressions: marked soft tissue swelling of the middle finger od the right hand with evidence of soft tissue foreign body, which is partially opaque in the soft tissues of the middle phalanx area of the right third finger.This appeared to lie on the dorsal surface.On same day, patient also underwent a surgery: incision and drainage of right hand, middle finger.On (b)(6) 1983: patient presented radiology examination of the nose due to nasal fracture.Impressions: depressed comminuted fracture of the nose and nasal septum.Patient also underwent a surgery with an open reduction of the fracture with septoplasty.On (b)(6) 1993: patient was admitted due to a neck injury/ hematoma, pharynx/ displacement of trachea.Patient underwent a tracheostomy, direct laryngoscopy surgery.Patient was discharged on (b)(6) 1993.Impressions: laryngeal injury with marked edema and hematoma of the left pyriform sinus and arytenoid.On same day patient also underwent a radiology exam of the lateral cervical spine due to history of injury.Impressions: essentially negative ap and lateral cervical spine.On (b)(6) 1993: patient presented for a ct exam of the neck due to laryngeal injury.Impressions: fracture is noted on the cricoid cartilage on the left side.There is slight separation of the thyroid cartilage and asymmetry suggesting that the thyroid cartilage has also been injured.Considerable soft tissue swelling was also noted.On (b)(6) 1993: patient presented for a physical exam due to pneumonia.Impressions: atelectasis versus pneumonia bilaterally in the lower lung fields.Patient also underwent a follow-up check due to history of neck trauma.Impressions: status post tracheostomy, placement and basilar alveolar disease most characteristic of atelectasis.On (b)(6) 1993: patient presented with radiology exam of the chest due to dyspnea.Impressions: interval development and increase of infiltrate right lower lobe with some slight improvement in the atelectatic changes in the left lower lobe area since (b)(6) 1993.On (b)(6) 1993: patient presented with a physical examination due to fever, vomiting and headache.Impressions: viral syndrome.On (b)(6) 1998: patient presented with a complaint of mid back pain.Patient underwent an x-ray pf chest and back due to back pain on same day.On (b)(6) 1999: patient presented with a kub exam.Impressions: double-j stent seen in the left collecting system.On same day patient presented with following pre-op diagnosis: left renal stone and underwent a cystoscopy stent and extracorporeal shock wave lithotripsy surgery.Patient tolerated the surgery and was in good condition.On (b)(6) 1999: patient presented with complaint of left flank pain.Patient underwent a physical exam.Impressions: left renal stone.On (b)(6) 1999: patient was diagnosed with left renal stone and left flank pain and underwent left percutaneous nephrostolithotomy surgery.Patient was discharged.Impressions: successful percutaneous left nephrostomy.The calix containing the lower pole calculus was entered and two tubes were placed.Patient tolerated well with no complications.On (b)(6) 2005: patient underwent mri of lumbar spine w/o contrast.Impression: there is mild disc desiccation and posterior disc bulges and facet and ligamentum flavum hypertrophic changes within the lumbar spine, the lower thoracic spine, and more prominent at l4-5 with relative mild canal stenosis and mild left lateral recess and foraminal encroachment and mild bilateral foraminal encroachment at l5-s1 as described above.On (b)(6) 2006: patient presented with chief complaints of redness, swelling, and pain in left foot, hypertension.Assessment: gouty arthritis deteriorated.On (b)(6) 2006: patient presented with chief complaints of pain and swelling in left foot and pain between shoulders.Assessments for gouty arthritis, lumbar spondylosis, ddd, thoracic pain, hypertension and osteoarthritis, were found unchanged from previous visits.On (b)(6) 2006: patient presented with chief complaints of worsened pain in lower back pain, hypertension, and osteoarthritis.Assessment: pain control deteriorated.On (b)(6) 2006: patient presented with chief complaints of lumbago, hypertension, and osteoarthritis.On (b)(6) 2006 patient presented with chief complaint of low back pain.On (b)(6) 2006: patient underwent mri of lumbar spine with flex and ext.Impression: mild degree of spinal stenosis at the l4-l5 level secondary to posterior element configuration , mild hypertrophic degenerative joint disease in the posterior facet joint and mild hypertrophy of the ligamentum flavum.The patient also underwent x-ray of lumbar spine w/flex and evt.Impression: very mild degree of curvature of the lumbar spine with convexity towards the right in the ap view which is questionable for a mild degree pf rotoscoliosis although this may simply be positional.On (b)(6) 2007: the patient underwent hemogram.Patient admitted with following diagnosis: lumbar disk degeneration.On (b)(6) 2007: patient presented with chief complaints of pain in all joints, toeson rt.Foot drawn over, osteoarthritis, hypertension.Assessments for gouty arthritis, lumbar spondylosis, ddd, thoracic pain, hypertension and osteoarthritis, were found unchanged from previous visits.On (b)(6) 2009: patient presented for evaluation for colon.On (b)(6) 2010: patient underwent colonoscopy.Patient presented with screening.Impression: diverticulosis in the sigmoid colon.Small internal hemorrhoids.On (b)(6) 2010: patient presented with chief complaint of right hand pain.On (b)(6) 2010: patient presented with chief complaint of osteoarthritis, hypertension, lumbago.Assessment: gouty arthritis improved.On (b)(6) 2010 patient presented with following diagnosis: hand pain and swelling.On (b)(6) 2012: patient presented with chief complaint of altered mental status and following diagnosis: adverse drug effect, back pain with radiculopathy.Review of constitutional system: drowsy/sleeping, but awakens to light touch and verbal stimulation.Review of psychiatric system: drowsy, but awakens, oriented to person, place and time.On (b)(6) 2012: patient underwent x-ray of chest.Impression: no acute cardiopulmonary pathology detected.On (b)(6) 2013: the patient presented with chief complaint of lumbar stenosis with mri lumbar, dvt study and after pt.Ros revealed: musculoskeletal: back pain, arthritis.Neurologic: difficulty with concentration, poor balance, numbness, falling down, tingling, memory loss.Psychiatric: complaint of sense of great danger, depression.Spectral and color-flow imaging along with compression augmentation techniques were performed through the right leg venous system.Impression: negative right leg venous ultrasound.Patient also underwent mri of the lumbar spine with and without contrast.Impression: previous fusion in and laminectomy at l4/l5 with a small amount of epidural and perineural granulation tissue.There is degenerative disc disease and arthritic change which produce neuroforaminal narrowing left-sided nerve root impingement at l4/l5 and bilateral nerve root impingement at l5/s1.On (b)(6) 2013: the patient was admitted.On (b)(6) 2013: the patient was presented for office visit with stroke symptoms.Impression: the patient had some expressive and cognitive impairment.On (b)(6) 2013: the patient was discharged from the hospital.Principal diagnosis: encephalopathy suspected secondary to medication, possibly secondary to not taking as prescribed.History of old stroke.Dyslipidemia with triglycerides.Acute on chronic kidney disease stage 3 most likely.Acute renal failure likely secondary to dehydration.Hypertension.Gout.Seasonal allergies.On (b)(6) 2013: the patient was presented for office visit with altered mental status.Assessments: altered metal status, hyperlipidemia, lumbago, obesity and hypertension.Mri impressions: stable appearance, unchanged from the prior study, benign stable extra axial cystic lesion overlying the left parietal lobe, suggesting an arachnoid cyst.The patient also underwent x rays of the chest due to cough.Impression: no active disease consolidation, pleural effusion, pneumothorax.Mild cardiomegaly.Normal pulmonary vessels.On (b)(6) 2013: the patient underwent ultra sound of renal due to renal failure.Impression: unremarkable renal ultrasound.Urinary bladder wall measure up to 4 mm in thickness.Again this may be seen secondary to nondistention or in cystitis.On (b)(6) 2013: the patient underwent mri head without iv contrast.Impression: stable appearance unchanged from the prior study of on (b)(6) 2013 with a benign stable extra axial cystic lesion overlying the left parietal lobe, suggesting an arachnoid cyst.The patient underwent xr, myelogram lumbar.Impression: lumbar myelogram performed without complication.Left posterior fusion l4-l5.Orthopedic hardware intact.Grade 1 spondylolisthesis l5-s1 without translation during flexion-extension.Spinal stenosis l5-s1 partial resolves during flexion without further translation of the lumbar vertebral elements.On (b)(6) 2015: patient underwent ct scan of head without iv contrast.Impression: no change with no evidence of acute pathology.Stable arachnoid cyst adjacent to the left frontal and parietal lobes.On (b)(6) 2015: patient underwent x-ray of chest.Impression: clear lungs with no focal infiltrate or pulmonary edema.Mild cardiomegaly.No pleural effusion or pneumothorax.Patient also underwent ct scan of head without iv contrast.Impression: no acute intracranial hemorrhage, mass effect or midline shift.On (b)(6) 2015: patient underwent ct scan of the chest with iv contrast, due to shortness of breath.Impression: there is no definite evidence of pulmonary emboli or aortic dissection.There is no significant mediastinal or hilar adenopathy.There is very mild patchy interstitial pathology in the lung bases bilaterally felt to be chronic without definite acute parenchymal or pleural pathology.Patient also underwent ct scan of head without iv contrast for tia.Impression: stable area of hypodensity and encephalomalacia, left superior posterior frontal lobe that has been described as arachnoid cyst on prior studies without evidence of interval acute abnormalities.Patient also underwent x-ray of chest.Impression: no active chest disease.On (b)(6) 2015: patient underwent ct scan of head without iv contrast for aphasia.Impression: persistent area of hypodensity left superior posterior frontoparietal region consistent with arachnoid cyst as has been previously documented with mri scan.There are no acute abnormalities.Patient also underwent x-rays of chest due to chest pain.Comparison study was made with result dated (b)(6) 2015.Impression: there are small lung volumes which accentuate cardiac contours and pulmonary vasculature.Allowing for this, no definite focal consolidation, pneumothorax, or pleural effusion is seen.Cardiac silhouette and mediastinal contours are felt to be within normal limits.On (b)(6) 2015: patient underwent mri of head without contrast for aphasia.Impression: negative for acute infarction.On (b)(6) 2015: patient got admitted in the hospital with altered mental status.On (b)(6) 2015: patient got discharged from the hospital.
 
Event Description
It was reported that on: (b)(6) 2015: patient presented for office visit with chief complaint of "sob/congestion".Patient reports fever.On (b)(6) 2016 patient presented for office visit with complaint of low back pain.Review of constitutional system: level of distress: chronically ill.Ambulation: limited ambulation, ambulation with cane, and abnormal tandem gait test (unable to heel, walk).Review of neurological system: "ble weakness", bilaterally throughout.Review of musculoskeletal system: joints, bone and muscles limited range of motion, lumbar spine: extension decreased by 30 deg, tenderness over the spinous process from l2-l5, lumbar atrophy, limited range of motion, tenderness, extensive scarring.On (b)(6) 2016 patient presented for office visit.Review of constitutional system: level of distress: chronically ill.Ambulation: limited ambulation, ambulation with cane, and abnormal tandem gait test (unable to heel, walk).Review of neurological system: "ble weakness", bilaterally throughout.Review of musculoskeletal system: joints, bone and muscles limited range of motion, lumbar spine: extension decreased by 30 deg, tenderness over the spinous process from l2-l5, lumbar atrophy, limited range of motion, tenderness, extensive scarring.
 
Event Description
It was reported that on (b)(6) 2010: the patient presented with a chief complaint of pain in right hand and underwent x-ray.Impression: probable right ring trigger finger.On (b)(6) 2010: the patient underwent mri of right hand due to right hand pain.Impression: short segment longitudinal split type tear of the flexor digitorum profundus tendon of the index finger at the level of the proximal interphalangeal joint.Suggestion of premature splaying of the extensor digitorum superficials tendon of the index finger, which may represent a partial thickness longitudinal type tear prior to the normal split of the tendon.Fluid signal intensity about the flexor tendons of the index fingers suggesting superimposed tenosynovitis with proximal extension as described.Slight displacement of the flexor tendons of the index finger in relation to the proximal phalanx such that partial a2 pulley injury is not excluded.Mild edema between the proximal phalanges and flexor tendons of the ring and long fingers as described such that mild tenosynovitis is not excluded.On (b)(6) 2015: the patient presented with chief complaint of low back pain, "si" pain, injection evaluation.On (b)(6) 2015: the patient presented with chief complaint of low back pain, si pain, injection evaluation.
 
Event Description
It was reported that on (b)(6) 2016: the patient presented 8.5 months post-op bilateral si joint fusion.Assessment: severe chronic bilateral severe chronic bilateral si (sacroiliac) joint dysfunction.Unresponsive to treatment.Severe chronic bilateral severe chronic bilateral si (sacroiliac) pain improving worsening improving worsening.Severe bilateral severe bilateral si joint arthritis improving worsening improving worsening.
 
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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 Key3600553
MDR Text Key15113446
Report Number1030489-2014-00326
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 09/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2009
Device Catalogue Number7510200
Device Lot NumberM110602AAE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/26/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/02/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Weight99
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