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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 7510600
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Burning Sensation (2146); Tingling (2171); Stenosis (2263); Discomfort (2330); Neck Pain (2433)
Event Type  Injury  
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.
 
Event Description
Per medical records: implant date(s): (b)(6) 2009 patient demographics: gender: male, initials: (b)(6), dob: (b)(6) 1950, weight: (b)(6), height:(b)(6), race: black, history/comorbidities: asthma, hypertension, spinal stenosis, surgeries: hernia repair, knee surgery, leg repair, lung and chest surgery, finger attachment, exploratory scrotal surgery, tonsillectomy, allergies/intolerance: dust, feather/down, mold, pollen, ragweed.Family medical: cancer, diabetes mellitus, hypertension.Social history: drinker, former smoker, medication: loratadine, cozaar, amlodipine besylate, spironolactone, docusate sodium, advair diskus, gabapentin, prednisone, sennosides, hydrocodone-acetaminophen, tramadol, norvasl, amlodipine besylate, docusate sodium, loratadine, xopenex, saw palmetto, percocet, baclofen, koratadine, esomeprazole, ondansetron, cefazolin, gelfoam, fentanyl, midazolam, propofol, troponin, oxycodone, naloxone, esomeprazole, senna.It was reported that on (b)(6) 2009 the patient presented for an office visit due to spinal stenosis.Impression: lumbar spondylosis without myelopathy.Lumbar spinal stenosis.Mobile spondylolisthesis.(b)(6) 2009 the patient presented with lumbar spinal stenosis.Lumbar spondylosis.The patient underwent following procedure: l4-5 posterior spinal decompression.Left l4-5 transforaminal lumbar interbody fusion with peek, bmp, and local autograft.Insertion of interbody device at l4-5 (stryker reliance).L4-s posterior spinal fusion with local autograft and bmp.Posterior spinal instrumentation, l4-5 (stryker xia).Per op notes: the end plates were curetted back to healthy, bleeding bone.Simultaneous to this, a large bmp kit was prepared.All previously harvested bone was morselized for use as local autograft.Two of the six bmp sponges from a large bmp kit were wrapped around local autograft.This was then packed anteriorly in the disc space along the annulus fibrosis.More local autograft and t\vo further sponges were packed into our cage.Using fluoroscopic guidance, an appropriate-sized cage was chosen.Ultimately, a 14 x 25 mm cage was chosen.Previously decorticated surfaces were covered with remaining bmp sponges packed with local autograft, that is, one bmp sponge per side.Our remaining local autograft was then packed over our bmp sponges.(b)(6) 2009 the patient underwent x-rays of chest.Impression: no pneumothorax and no pneumonia seen on this portable study.(b)(6) 2009 the patient underwent xrays of the lumbar spine.Impressions: status post posterior spinal fusion, laminotomy and intervertebral bone graft placement at the level of l4-l5.(b)(6) 2009 the patient presented for follow up.X-rays revealed evidence of stable hardware and alignment as well as an evolving interbody and transverse fusion mass.Impression: status post l4-5 tllf and posterolateral fusion/instrumentation.The patient underwent physical therapy: diagnosis: s/p lumbar fusion.The patient underwent x-rays of lumbar spine.Impression: unchanged appearance following anteroposterior l4-s instrumented fusion and discectomy with unchanged residual anterolisthesis of l4 on l5.(b)(6) 2010 the patient complained of burning pain in his left side.He had weakness in his left hip.(b)(6) 2010 the patient presented for follow up of l4-5 posterior spinal decompression and fusion performed on (b)(6) 2009.Impression: status post l4-5 transforaminal lumbar interbody fusion and postero-iateral fusion/instrumentation.The patient underwent x-ray of lumbar spine.Impression: instrumented posterior spinal fusion at l4-ls, anterior spinal fusion and discectomy at l4-l5, with unchanged grade 1 l4-l5 anterolisthesis.Mild l3-l4 disc disease (b)(6) 2010 the patient underwent emg.Emg of the left medial gastrocnemius showed 3+ fibs and psws.(b)(6) 2010 the patient underwent lumbar myelogram and post myelogram ct.Impression: status post posterior spinal decompression at l4-l5 with partial fusion of the intervertebral disc at this level and no evidence of hardware complication.There is moderate central canal stenosis slightly superior to the l4-5 disc level behind the l4 vertebral body.Mild to moderate left neural foraminal narrowing at l3-l4, bilateral mild to moderate foraminal narrowing at l4-l5 and right mild to moderate neural foraminal narrowing at l5-s1.Mild to moderate central canal stenosis at t11-12 as well as mild central canal stenosis at l3-l4 due to degenerative changes.Some of the cauda equina nerve roots appear to be enlarged, which could be related to chronic inflammation in the setting of prior surgery.(b)(6) 2010 the patient presented for follow up of l4-5 posterior spinal decompression and fusion performed on (b)(6) 2009.Impression: status post l4-5 tlif, left.(b)(6) 2010 the patient underwent x-ray of lumbar spine.Impression: unchanged combined anterior and posterior spinal fusion with posterior decompression at l4-l5.Moderate unchanged l3-l4 and l5-s1 degenerative disc disease.(b)(6) 2010 the patient presented for follow up of l4-5 posterior spinal decompression and fusion performed on (b)(6) 2009.(b)(6) 2010 the patient underwent x-ray of lumbar spine.Impression: unchanged anterior and posterior instrumented spinal fusion of l4-l5, with no abnormal translatory motion upon bending.Mild degenerative disc disease at 13-14 and 15-s1.(b)(6) 2010 the patient underwent x-rays of lumbosacral spine.Impression: instrumented posterior spinal fusion and decompression of l4-l5, without motion at the fused segments.Unchanged grade 1 degenerative anterolisthesis of l3 on l4, which slightly worsened during flexion and reduces with extension.Unchanged mild l3-l4 and moderate l5-31 degenerative disc disease.(b)(6) 2010 the patient underwent-rays of cervical spine.Impression: mild c4 on c5 and c5 on c6 anterolisthesis, unchanged in flexion and extension.Mild c4-c5 and moderate c5-c6 and c6-c7 degenerative disc disease at c5-c6 central canal stenosis.Moderate bilateral facet joint osteoarthritis from c3-c4 to c6-c7.(b)(6) 2010 the patient presented for an office visit due to right knee pain.Impression/diagnosis: right medial compartment knee os teoarthritis.The patient underwent x-ray of knee.Impression: mild to moderate right knee medial compartment osteoarthritis.Bilateral healed proximal tibia fractures.(b)(6) 2010 the patient presented for follow up of l4-5 posterior spinal decompression and fusion performed on (b)(6) 2009.The patient underwent physical therapy.Diagnosis: s/p lumbar fusion (b)(6) 2010 the patient presented for follow up.X-rays: ap and lateral, flexion-extension l-spine films, which revealed evidence of stable implants and alignment as well as an evolving inter transverse and interbody fusion mass.Impression: status post l4-5 posterior spinal decompression and fusion.The patient underwent x-ray of spine.Impression: unchanged instrumented anterior and posterior fusion of ls-s1 in near anatomic position.Unchanged l3-l4 and l5-s1 degenerative disc disease.(b)(6) 2011 the patient presented for follow up.Impression: status post l4-5 posterior spinal decompression and fusion.X-rays: ap and lateral flexion-extension l-spine films, which revealed evidence of solid fusion mass extending from l4 to l5 without evidence of implant failure.The patient underwent x-rays of spine.Impression: unchanged posterior decompression with posterior and interbody fusion, l4-ls, with mild angular motion at the fused segments.Unchanged moderate ls-s1 degenerative disc disease.(b)(6) 2011 the patient presented for follow up.X-rays: imaging studies include ap and lateral, flexion-extension l-spine films, which revealed evidence of a solid fusion mass extending from l4 to l5.There were also x-rays of his left hip, which fail to reveal evidence of significant degeneration.Impression: status post l4-5 posterior spinal decompression and fusion.Left hip pain.Rule out bursitis.(b)(6) 2011 the patient underwent radiology test of hip.Impression: posterior spinal decompression and fusion of l4-l5.No appreciable motion at the fused segment with flexion or extension.Unchanged grade 1 anterolisthesis of l3 on l4, which does not change with flexion or extension.Unchanged moderate degenerative disc disease of ls-sl.Normal left hip.(b)(6) 2011 the patient underwent mri of the pelvis without contrast.Impression: bilateral greater trochanteric bursitis, more prominent on the left, with left gluteus medius tendinopathy and a partial thickness tendon tear.Bilateral proximal hamstring tendinopathy, more prominent on the right, with a partial thickness tear at the origin of the right hamstring tendons.Bilateral hip chondrosis with bilateral nondisplaced anterior/superiorlabral tears.(b)(6) 2012 the patient presented for an office visit.Mrl of the left hip per report showed gluteus medius tendinopathy with associated tear on the left.Also chondrosis of both hips is noted.Impression: left lateral hip pain-greater trochanteric pain syndrome with gluteus medius tendinopathy.Left neck and upper trapezius pain-myofascial pain.Status post lumbar fusion (b)(6) 2012 the patient presented with two-weeks of proximal left arm weakness.X-rays revealed mild c4-5 disc degeneration, moderate c5-6 disc degeneration with evidence of central canal stenosis, moderate c6-7.Moderate facet arthropathy at c3-4 and c6-7.Impression: nondirectional axial neck pain with left arm weakness and a c5-c6.(b)(6) 2012 the patient underwent mri of cervical spine.Impression: severe facet and uncovertebral joint osteoarthrosis and disc degenerative changes resulting in mild c3-c4 central canal stenosis, as well as multilevel bilateral neural foramina stenosis, as detailed above.(b)(6) 2012 the patient had numbness in left arm.Patient had neck injection back in (b)(6) 2012.(b)(6) 2012 the patient presented for follow up evaluation.Impression/diagnosis: progressive left arm pain and proximal weakness, possible parsonage turner syndrome (b)(6) 2012 the patient presented with numbness, tingling and weakness in the left upper extremity.Impression: left brachial plexopathy affecting primarily the upper trunk with denervation potentials in the left deltoid, biceps and infraspinatus.(b)(6) 2012 the patient underwent mri brachial plexus with and without contrast.Impression: no atrophy or signal abnormality of the biceps or deltoid muscles.Aside from a supraclavicular lymph node which appears separate from the brachial plexus as described above, no abnormality or impingement upon the brachial plexus is seen.(b)(6) 2012 the patient underwent emg.The patient complained of left upper extremity weakness and pain for the past 2 months.(b)(6) 2012 the patient presented for follow up evaluation.Impression: left upper extremity weakness with findings consistent with a brachial plexopathy.Patient mri showed only mild c3-c4 stenosis.(b)(6) 2012 the patient presented for follow up evaluation for brachial plexopathy.Impression: left brachial plexopathy consistent with parsonage-turner syndrome (b)(6) 2013 the patient presented for an office visit.Review of x-ray/studies: plain films of his left shoulder taken and reviewed today show glenohumeral and ac joint arthritis.Impression/diagnosis: left brachial plexopathy with some clinical improvement.Left glenohumeral osteoarthritis.(b)(6) 2013 the patient presented for follow up.Impression: status post l4-s posterior spinal decompression and fusion.Rule out rotator cuff injury on the left.Rule out juxtafusional stenosis.(b)(6)2013 the patient underwent mri of lumbar spine.Impression: interval anterior and posterior fusion at l4-l5 with increased spinal canal stenosis at l2-l3 and l3-l4.The spinal canal is patent at l4-l5.(b)(6) 2013 the patient underwent physical therapy.Diagnosis: l2-3, l3-4 juxtafusional stenosis.(b)(6) 2013 the patient underwent mri of upper extremity joint left without contrast.Impression: large, partial-thickness articular sided tear of the left supraspinatus tendon with delaminating extension into the infraspinatus with mild fatty atrophy of the supraspinatus muscle and undersurface retraction of the tendon.Moderate tendinopathy of the subscapularis tendon and long head of the biceps tendon.Subacute on chronic denervation of the deltoid and teres minor muscles, consistent with left axillary neuropathy.Severe osteoarthritis of the posterior glenoid with associated degenerative labral tear.Moderate acromioclavicular joint osteoarthritis.(b)(6) 2013 the patient presented with sharp pain in shoulder.Lumbar transforaminal epidural steroid injection (selective nerve root injection) at l2-3, l3-4 was injected.(b)(6) 2013 the patient presented with pain in hips.Impression:interval anterior and posterior fusion at l4-l5 with increased spinal canal stenosis at l2-l3 and lj-l4.The spinal canal is patent at l4-l5.(b)(6) 2013 the patient for an office visit.Mri showed a rotator cuff tear and arthritis in the shoulder.(b)(6) 2013 the patient presented for pain follow up evaluation.Patient complained of discomfort in bilateral hips when walking.Impression: interval anterior and posterior fusion at l4-l5 with increased spinal canal stenosis at l2-l3 and l3-l4.The spinal canal is patent at l4-l5.Musculoskeletal examination: antalgic gait.Neurologic exam: cranial nerves normal.Balance normal; psychiatric: oriented x3, memory intact, and alert.Normal mood and affect.Normal insight and judgment.(b)(6) 2013 the patient complained about discomfort in his right buttock.(b)(6) 2013 the patient presented with back pain and left shoulder/arm pain.Assessment: other chronic pain; lumbosacral spondylosis, w/o myelopathy; post laminectomy syndrome lumbar; spinal stenosis - lumbar region; enthesopathy - left shoulder.Lumbar transforaminal epidural steroid injection (selective nerve root injection) at bilateral l2-3, l3-4 was injected.(b)(6) 2013 the patient presented for follow up evaluation.Impression: left brachial plexopathy.History of c5-6 disc protrusion.Rotator cuff tear and posterior glenoid osteoarthritis seen on recent mri.(b)(6) 2013 the patient underwent mri of cervical spine.Impression: moderate multilevel degenerative disc disease resulting in mild spinal canal stenosis at c3-c4, c5-c6, and c6-c7.Foraminal stenosis are seen bilaterally at multiple levels.Overall, the degenerative changes have not significantly changed since the prior exam from (b)(6) 2012.(b)(6) 2013/(b)(6) 2014 the patient presented for follow up of priapism and urinary retention.
 
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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 Key5076922
MDR Text Key25772788
Report Number1030489-2015-02358
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 08/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/01/2011
Device Catalogue Number7510600
Device Lot NumberM110808AAP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/17/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/21/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight111
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