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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 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Muscle Spasm(s) (1966); Neuropathy (1983); Weakness (2145); Burning Sensation (2146); Stenosis (2263); Numbness (2415); Neck Pain (2433)
Event Type  Injury  
Manufacturer Narrative
(b)(6).(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
It was reported that on: (b)(6) 2005: patient got admitted for opiate abuse/ dependency and depression.Patient underwent psychiatric evaluation and physical examinations.Diagnosis: chronic low back pain syndrome, chemical dependency to opiates as well as benzodiazepine, hyperlipidemia, gastroesophageal reflux disease.On (b)(6) 2005, patient underwent psychiatric evaluation.On (b)(6) 2005: patient was discharged from the hospital.On (b)(6) 2005: patient presented with complaint of low back pain and bilateral lower extremity pain.Patient's x-ray of lumbar spine showed an l5-s1 grade ii spondylolisthesis with a pars defect bilaterally.Mri from (b)(6) 2005 showed l5-s1 grade 2 spondylolisthesis with bilateral foraminal stenosis.On (b)(6) 2005: patient underwent x-ray of chest preop lumbar laminectomy.Impression: no evidence of acute disease or interval change.On (b)(6) 2005: patient admitted to facility with following pre-op diagnoses: l5-s1 spondylolisthesis grade 2; l4-5 facet hypertrophy; l5 radiculopathy on the left.For which patient underwent following procedure: l5 laminectomy (gill procedure) decompression; bilateral foraminotomy of l5-s1; l4-5 posterior interbody fusion; l5-s1 posterior interbody fusion; posterior lateral fusion l4-5 and l5-s1 using local bone graft; posterior instrumentation l4-5 and l5-s1 segment using legacy; application of cages, l4-5, dmp; application of cage l5-s1 bmp; local bone graft.Per op notes, at l5-s1 level, the disk was instrumented with cages with two sponges of bmp.One from each side was inserted into disk space.The middle of the disk space was packed with local bone graft.Attention was placed on the l4-l5 level.14 x 26 mm was driven obliquely into the disk space, packed with two sponges of bmp underneath the cage.Surgeon put an additional two sponges and local bone graft.Positions of these cages were monitored with c-arm intensifier.Then with the unibolts in the posterior lateral aspect with the spinal process was already decorticated surgeon placed a local bone graft and two sheets of bone matrix.Patient tolerated the procedure well with no complications reported.Patient underwent x-ray of lumbar spine intra-op.Impressions: transpedicle screws and posterior rods were seen bilaterally fusing l4, l5 and s1 levels.There were also fusion devices within the interspaces at these levels.There was mild anterior subluxation of l5 in relationship to s1.Hardware appeared intact and the vertebral bodies otherwise appear in good alignment.On (b)(6) 2005: patient got discharged from facility.On (b)(6) 2005: patient presented with complaint of lower back soreness.On (b)(6) 2005: patient presented with complaint of muscle spasms.Patient underwent x-ray of lumbar spine which showed screws in good position.On (b)(6) 2007: patient presented for an evaluation of his shoulder.Impression: type 2-3 acromion, ac joint pain, cuff pain.Impingement, partial thickness rotator cuff tears.On (b)(6) 2007: patient underwent mri of lumbar spine without and with contrast.Impression: there was postsurgical change at the l5-s1 level with mild grade i anterior spondylolisthesis of l5 upon s1 and some enhancing fibrosis about the thecal sac.No significant stenosis was present.Post surgical changes at l4-5 are present with no significant stenosis.Patient also underwent mri of left shoulder.Impression: chronic spurring and degenerative changes of the acromioclavicular joint.Focal partial thickness tear of the distal supraspinatus tendon at the level of insertion on greater tuberosity of the humerus.Paralabral cyst along the anterior inferior margin of the glenoid labrum.Some degenerative change of the glenoid with mild spurring and subchondral bony changes seen at this level as well.On (b)(6) 2007: patient presented for a followup visit with history of back and leg pain.On (b)(6) 2007: patient presented with pre-op diagnosis of: left shoulder impingement syndrome.Left shoulder internal derangement.Left shoulder ac joint arthritis and pain.For which patient underwent following procedure: left shoulder arthroscopic decompression.Left shoulder debridement of glenohumeral joint, including the cuff and the glenoid arthritic changes.Left shoulder distal clavicle excision, complete.Patient tolerated the procedure well with no complications reported.After which patient had following post-op diagnoses: left shoulder anterior glenoid arthritic changes along the anterior labrum, grade iii and iv but in a small area along the edge of the labrum without instability.A 10% rotator cuff undersurface tear.On (b)(6) 2007: patient presented for an office visit.Impression: status post decompression, distal clavicle excision and debridement of a partial thickness cuff tear, doing well.On (b)(6) 2011: patient presented with complaint of low back pain.X-rays of lumbar spine showed well healed fusion at l4-5 and l5-s1.And very mild disc space narrowing at l3-4.Also, there were some bilateral sacroiliac joint changes.Impression: acute lumbar strain.Likely s1 joint dysfunction.Previous fusion at l4-5 and l5-s1.On (b)(6) 2012: patient presented for a recheck with complaint of neck and pain in right arm.Patient also underwent x-ray of cervical spine which showed disk space collapse at c4-5, c5-6 and c6-7, with anterior osteophyte formation.Impression: "ddd" of the cervical spine.Cervical spondylosis.Possible right cervical radiculopathy.Previous lumbar fusion of l4-5 and l5-s1.On (b)(6) 2012: patient underwent mri of cervical spine without contrast due to neck pain and right arm radiculopathy.Impressions: multilevel advanced degenerative disc disease cervical spine most notable at c4-c5 and c5-c6 with associated uncovertebral hypertrophy and severe right-sided neural foraminal stenosis.On (b)(6) 2012, (b)(6) 2013: patient presented for a recheck with complaint of neck pain.Impression: "ddd" of the cervical spine.Cervical spondylosis.Uncovertebral joint arthritis of the cervical spine.Foraminal stenosis of the cervical spine.On (b)(6) 2013, patient presented for follow-up.Patient reported constant neck pain.Mri of cervical spine showed degenerative changes at several levels, with narrowing of the central canal.On (b)(6) 2013: patient presented for a recheck with worsening of neck and arm pain and also underwent hepatitis/hiv testing.Worsening neck and arm pain, with neck pain radiating posteriorly behind the scapular area and into shoulder blade.Patient underwent x-ray of chest.Impression: normal chest.Mri from (b)(6) 2012 showed disc degeneration at c4-5 and c5-6, worse at 5-6, producing central stenosis.Patient described numbness and tingling in left middle finger.Impression: degenerative disk disease of c4-5 and c5-6."hnps" of c4-5 and c5-6.C6 radiculopathy bilaterally.Central stenosis of the cervical spine.Bilateral foraminal stenosis at c4-5 and c5-6.Patient also underwent x-ray of chest.Impression: normal chest.On (b)(6) 2013: patient presented with pre-op diagnoses as: c5- 6 and c4- 5 disk herniation.Bilateral foraminal stenosis at c4- 5 and c5- 6.Bilateral foraminal stenosis at c4-5 and c5-6.Right c6 radiculopathy.Degenerative disk disease cervical spine.For which, patient underwent following procedures: anterior cervical fusion at c5- 6 and c4- 5.C5 corpectomy decompression with bilateral foraminotomies.Anterior instrumentation c4-5 and 6 using the snowcap plate from lanx medical.Application of a cage at the c5 corpectomy site using harms cage 10x30 mm cut at length from depuy spine.Local bone graft from the corpectomy site at c5.C-arm image intensifier two hours.Patient tolerated the procedure well with no complications reported.On (b)(6) 2013: patient presented for a recheck, status post cervical fusion at c4-5 and c5-6 with complaint of low back and right leg pain with numbness and burning sensation.Impression: solid lumbar fusion.Disk bulge of l3-4.L3 radiculopathy on the right.Bony overgrowth at the l4-5 foramen.Status post acf.On (b)(6) 2013, patient reported back pain and low back pain.Burning pain that radiates into right leg with occasional numbness in leg.Impression: l3 radiculopathy on the right, lumbar strain, six weeks post-op two level acf.On (b)(6) 2013, patient presented for evaluation of mri of lumbar spine which showed instrumented fusion at l4-5 and l5-s1, both levels appear to be well healed.The level above l3-4 was in good condition.The patient had disc desiccation at l1-2, with a mild bulge, but overall the levels above the fusion looked good.L4-5 looked good as well.At l5-s1 there appears to be bony overgrowth in the foramen on the right side.Patient underwent mri of lumbar spine due to low back and right leg pain.Impression: mild lumbar spine convexity to the left which can be consistent with mild levoscoliosis.Broad based right paracentral degenerative l1-2 disc bulge with mild diffuse l2-3 and l3-4 disc bulges.No evidence for lumbar disk herniation nor significant central canal stenosis.Post surgical changes of bilateral l4-s1 plif.Grade 1 spondylolisthesis of l5 on s1.On (b)(6) 2013: patient underwent ct scan of lumbar spine without contrast.Impression: patient is status post posterior fusion from l4-s1.Endplate changes at l5-s1 are presumed positive in nature.Otherwise, mild degenerative changes were seen without evidence for significant central canal stenosis or neural foraminal narrowing.(b)(6) 2013, patient presented for evaluation of ct scan of lumbar spine which showed disc bulge at l3-4, fusion appeared healed but patient had bony overgrowth entering foramina at l4-5 bilaterally, worse on right side.On (b)(6) 2013, patient presented for follow-up, three months post-op acf of c4-5 and c5-6.Patient reported pain in right leg.On (b)(6) 2013, patient presented for follow-up on continued leg pain.Patient reported back pain and right leg pain.On (b)(6) 2013: patient presented for a recheck with complaint of minimal neck pain.Impression: six months post-op from two-level acf, now likely solid fusion.Disk bulge of l3-4.L3 radiculopathy on the right.Bony overgrowth at l4-5.On (b)(6) 2014: patient presented for a recheck with complaint of increasing bilateral back pain.Impression: nine months post-op from two-level acdf.Disk bulge of l3-4.Right l5 nerve root irritation.Bony overgrowth at l4-5.Lower back pain.On (b)(6) 2014: patient underwent mri of lumbar spine without contrast.Impression: status post fusion l4-l5 and l5-s1 without evidence of complicating process; mild broad-based protrusion/disc bulges l1-l2 through l3-l4.On (b)(6) 2014: patient presented for the results of his updated mri of lumbar spine.Impression: almost one year postop from two-level acf.Degenerative disk disease of l1-2 and l2-3.Disk bulge of l1-2.Annular tear of l1-2.Status post lumbar fusion of l4-5 and l5-s1.Foraminal stenosis at l4-5 and l5-s1 due to bony overgrowth.Si joint dysfunction on the left.On (b)(6) 2014, patient presented for follow-up for continued back and bilateral leg pain.Impression: almost one year postop from two-level acf.Degenerative disk disease of l1-2 and l2-3.Disk bulge of l1-2.Annular tear of l1-2.Status post lumbar fusion of l4-5 and l5-s1.Foraminal stenosis at l4-5 and l5-s1 due to bony overgrowth.Si joint dysfunction on the left.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5537557
MDR Text Key41528442
Report Number1030489-2016-00858
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,Followup
Report Date 03/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510400
Device Lot NumberM114004AAC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/09/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age00043 YR
Patient Weight91
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