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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); Chest Pain (1776); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Tingling (2171); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Anxiety (2328); Injury (2348); Numbness (2415); Neck Pain (2433); Chest Tightness/Pressure (2463); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
It was reported that the patient underwent spine fusion surgery on the lumbar region at levels l4-l5.During the surgery, the patient was implanted with only select parts of rhbmp-2 and collagen sponge.Post-op, the patient complained of continued low back pain with radiculopathy and burning pain into his left lower extremity.Patient still continues to experience chronic low back pain with radiculopathy down his left leg.Patient has difficulty walking and often falls due to numbness in his left leg.Patient injuries prevented her from practicing daily life activities and reportedly the patient has suffered serious and permanent injuries.
 
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.
 
Manufacturer Narrative
(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on (b)(6) 2013: patient presented with following pre-op diagnoses: adjacent segment degeneration, l4-5.Status post posterior spinal circumferential fusion, l5-s1.For which, patient underwent following procedures: exploration of posterior spinal fusion, l5-s1.Removal of instrumentation of l5-s1.Revision of bilateral l5 pedicle screws.Segmental instrumentation, l4-s1.Posterior spinal fusion, l4-l5.Patient tolerated the procedure well with no complications reported.Patient also presented with following pre-op diagnoses: lumbar degenerative disk disease, l4-l5.Bilateral facet arthropathy, l4-l5.Status post posterior spinal fusion and plif at l5-s1 by a different provider.For which, patient underwent following procedures: anterior lumbar interbody fusion at l4-l5.Placement of peek interbody cage, l4-l5.Patient was implanted with peek interbody cage, large.A 10 mm by 8 degree large footprint.A 30 cc cancellous allograft.Small bmp.Per op notes, once the diskectomy was complete to satisfaction, i then decorticated the inferior endplate of l4 and superior end plate of l5.A 10mm large footprint by 8 degrees perimeter peek cage filled with a small bmp and cancellous allograft, into the disk space in standard fashion.Lateral fluoroscopy demonstrated satisfactory positioning.Patient tolerated the procedure well with no complications reported.On (b)(6) 2013: patient presented with complaint of cough, shortness of breath.Impression: acute bronchitis.On (b)(6) 2013: patient presented with complaint of gout and pain in right big toe.Assessment: gout arthritis; lumbar radiculopathy with muscle spasms; anxiety disorder.On (b)(6) 2013: patient presented for a follow up visit status post anterior posterior spinal fusion at l4-5 above a previous fusion at l5-s1.Impression: six week's status post anterior posterior reconstruction at l4-5.New sided left leg pain.Patient also underwent x-ray of lumbar spine due to low back pain.Impression: minimal retrolisthesis at l4-5, otherwise normal alignment.On (b)(6) 2013: patient presented for a follow up visit status post anterior posterior spinal fusion at l4-5 above a previous fusion at l5-s1.Impression: two month's status post anterior posterior spinal fusion at l4-5 above a previous fusion, ls-51.Ongoing back and leg pain.Patient underwent x-ray of lumbar spine due to low back pain radiating left leg with numbness tingling.Impression: anterior/posterior fusion of l4-s1 with solid anterior/posterior bony fusion of the l5-s1.No evidence of suspicious high-grade central canal or foraminal narrowing.On (b)(6) 2013: patient presented with complaint of left lung/ chest pain - started last evening.Assessment: pleurisy.Impression: reproducible chest pain with pain on inspiration secondary to the pleurisy.On (b)(6) 2013: patient presented for a re-eval.Assessment: lumbar disc degeneration; lumbar radiculopathy.On (b)(6) 2013: patient presented with complaint of breathing troubles.Assessment: acute sinusitis; chronic obstructive pulmonary disease.On (b)(6) 2013: patient presented for a follow up visit status post anterior posterior spinal fusion at l4-5 above a previous fusion at l5-s1.Patient also underwent x-ray of lumbar spine due to low back pain.Impression: post l4-s1 ap fusions without evidence of complication or change.Degenerative changes as above.On (b)(6) 2013: patient presented for med refill.Assessment: persistent acute sinusitis.Lumbar radiculopathy with lumbar disk degeneration, status post surgery.On (b)(6) 2014: patient presented with complaint of chest tightness, breathing troubles.Assessment: exacerbation of copd.On (b)(6) 2014: patient presented for a hospital re-eval, med refill.Assessment: lumbar disc degeneration; lumbar radiculopathy.On (b)(6) 2014: patient underwent mri of cervical spine without contrast due to indication of neck pain and arm pain.Impression: normal alignment.No fracture or spondylolisthesis.Normal cord signal.Stable postoperative changes anterior fusion c5-6.4.At c6-7, broad-based disc osteophyte complex with moderate narrowing of the spinal canal.Moderate bilateral neural foraminal narrowing.This has worsened slightly from the previous exam.5.Stable mild narrowing of the spinal canal and neural foramina at c3-4 and c4-5.On (b)(6) 2014: patient presented with preprocedure diagnosis as neck and arm pain.Cervical radiculitis.For which patient underwent fluoroscopic-guided, contrast-controlled c7-t1 intralaminar epidural steroid injection.Patient tolerated the procedure well with no complications reported.On (b)(6) 2014: patient underwent x-ray of chest, "pa" and lateral.Impression: negative chest.On (b)(6) 2014: patient presented for a followup with chief complaint of neck and bilateral shoulder pain.Impression: adjacent segment degeneration at c4-5 and c6-7.Bilateral foraminal stenosis at c4-5 and c6-7.On (b)(6) 2014: patient presented for med refill.Assessment: cervical disc degeneration; lumbar radiculopathy, chronic pain syndrome.On (b)(6) 2014: patient presented for preoperative history and physical for cervical fusion.Impression: preoperative history and physical.Degenerative disc disease of the cervical spine.Status post cervical disc fusion c5-c6.Status post lumbar fusion l4-l5, l5-sl.Hypertension."copd".Intermittent colitis, stable.On (b)(6) 2014: patient presented with following pre-op diagnoses: 1.Cervical spondylosis, c4-c5, c6-c7.Status post anterior cervical decompression and fusion, c5-c6.Bilateral foraminal stenosis, c4-c6, c6-c7.For which, patient underwent following procedures: anterior cervical decompression and fusion, c4-c5.Anterior cervical decompression and fusion, c6-c7.Removal of instrumentation, c5-c6.Exploration of fusion, c5-c6.Anterior instrumentation, c4-c7.Placement of structural cortical cancellous allograft c4-c6 and c6-c7.Patient tolerated the procedure well with no complications reported.On (b)(6) 2014: patient underwent ct of chest due to indication of shortness of breath and recent spine surgery.Impression: suboptimal evaluation for pulmonary embolism.No significant central pulmonary embolism identified.If there is strong clinical concern for peripheral pulmonary embolism consider repeat exam.Mild discoid atelectasis or scar right lower lobe.No other acute cardiopulmonary disease appreciated.Patient also underwent ct of chest due to hypoxia.Impression: no pulmonary embolism.Postsurgical changes anterior inferior neck.On (b)(6) 2014: patient presented with complaint of swelling after neck surgery.Impression: revision of surgical fusion performed approximately 5 days ago.Swelling in the neck after surgery, resolved.Exacerbation of chronic obstructive pulmonary disease.On (b)(6) 2014: patient presented with refill request and for recheck regarding neck pain.Impression: degenerative disk disease cervical spine with radicular pain.De-generative disk disease lumbar spine with radicular pain.On (b)(6) 2014: patient presented with a refill request.Impression: chronic obstructive pulmonary disease with exacerbation.On (b)(6) 2014: patient presented for a follow up status post anterior cervical decompression and fusion at c4-5 and c6-7 above and below a previous fusion at c5-6.Impression: six weeks status post anterior cervical decompression and fusion at c4-5 and c6-7 above and below a previous fusion at c5-6.On (b)(6) 2014: patient presented with breathing problem and for refill request.Impression: degenerative disc disease of lumbar and cervical spine.Radiculopathy, neck and low back pain.Chronic obstructive pulmonary disease, chronic.On (b)(6) 2014: patient underwent cervical spine myelogram due to neck pain radiating to right shoulder and arm.Conclusion: anatomic alignment and preservation of the normal cervical lordosis status post interval extension of previously demonstrated c5-6 anterior discectomy, interbody fusion and anterior fixation to how include c4 through c7.Swollen or compressed c6 nerve roots bilaterally.Swollen or compressed c7 nerve roots bilaterally.Persistent spinal canal stenosis at the c6-7 level produced by a combination of ligamentous buckling and persistent endplate osteophytes without frank compression on the spinal cord.On (b)(6) 2014: patient presented for a recheck and complained of developing some seasonal allergies, congestion in his nose, and drainage in back of his throat.Impression: seasonal allergies.On (b)(6) 2014: patient presented with continued sinus congestion and rhinitis.Impression: chronic sinusitis with rhinitis.Chronic obstructive pulmonary disease requiring oxygen.Cervical discogenic disease status post laminectomy with persistent pain with radicular pain into his right arm.On (b)(6) 2014: patient presented with complaint of increasing shortness of breath.Impression: exacerbation of his chronic obstructive pulmonary disease.Chronic neck and back pain, with degenerative disk disease.On (b)(6) 2014: patient presented for a follow up visit with complaint of continued and significant neck and right shoulder pain.Impression: continued neck and shoulder pain status post anterior cervical decompression and fusion at c4-5 and c6-7 above and below the previous fusion at c5-6.On (b)(6) 2014: patient presented for a recheck regarding his chronic pain and neuritis associated with his neck and back disability.Impression: chronic obstructive pulmonary disease.Degenerative disk disease, cervical and lumbar spine.Osteoarthritis, multiple joints.On (b)(6) 2014: patient presented with continued shortness breath.Impression: exacerbation of his chronic obstructive pulmonary dis ease.Degenerative disk disease cervical and lumbar spine.Hypertension.On (b)(6) 2014: patient presented for a recheck regarding his "copd" and his chronic neck pain.Impression: degenerative disc disease cervical spine and lumbosacral spine, status posts diskectomy both areas.Chronic pain.Hypertension.Chronic obstructive pulmonary disease, improved with the daliresp 500 mcg daily.On (b)(6) 2014: patient presented for med refill.Impression: degenerative disk disease lumbar spine with radicular pain.Chronic obstructive pulmonary disease.Gastroesophageal reflux disease.On (b)(6) 2014: patient presented for a follow up visit with complaint of continued and significant neck and right shoulder pain.Anterior posterior and lateral views of the cervical spine demonstrated satisfactory positioning of implants.Impression: six months status post anterior cervical decompression and fusion at c4-5 and c6-7 above and below a previous fusion at c6-7.Patient underwent ct of cervical spine.Impression: stable appearance of postsurgical changes from c4-5, cs-6 and c6-7 discectomies with fusion.On (b)(6) 2014: patient presented for recheck regarding his copd and his chronic back pain.Impression: hyperlipidemia.Chronic obstructive pulmonary disease.On (b)(6) 2014: patient underwent ct of cervical spine without contrast due to indication of spondylosis/ radiculitis/stenosis.Impression: anterior fixation plate bridging c4-c7 is unchanged having satisfactory appearance.There is been mild interval resorption of the interbody fusion graft at the c4-5 with lucency interposed between the graft and superior endplate.Solidly incorporated interbody fusion grafts at c5-6 and c6-7 are unchanged.Minor multilevel spondylosis otherwise detailed above without significant central or foraminal stenosis.On (b)(6) 2014: patient presented for a follow up visit with complaint of ongoing neck pain.Impression: delayed union and impending pseudoarthrosis at c4-5 and c6-7.Loosening of instrumentation at c4 and c7.On (b)(6) 2014: patient presented for med refill.Impression: degenerative disk disease, lumbosacral spine.Degenerative disk dis ease of the cervical spine with nonunion fusion.On (b)(6) 2015: patient underwent x-ray of chest due to indication of shortness of breath.Impression: hyperinflation, otherwise grossly normal chest.On (b)(6) 2015: patient presented with increasing shortness of breath.Impression: exacerbation of chronic obstructive pulmonary disease.On (b)(6) 2015: patient presented for recheck after his hospitalization for an exacerbation of his copd.Impression: exacerbation of his chronic obstructive pulmonary disease.Chronic neck and back pain with radicular pain into the legs and into his arms.On (b)(6) 2015: patient returns for recheck regarding increasing shortness breath, along with continued neck pain.Impression: exacerbation of copd.Discogenic disease cervical spine.On (b)(6) 2015: patient presented for a pre operative exam.On (b)(6) 2015: patient presented with following pre-op diagnoses: pseudoarthrosis at c4-c5 and c6-c7.Loosening of instrumentation c4-c5.Status post anterior cervical decompression and fusion, c4-c5, and c6-c7 above and below previous fusion at c5-c6.For which, patient underwent following procedures: posterior cervical fusion c4-c7.Segmental instrumentation c4-c7.Neural monitoring.Patient tolerated the procedure well with no complications reported.Intraoperative neurophysiologic report showed: normal upper limb transcranial electrical motor evoked potentials; normal lower limb transcranial electrical motor evoked potentials; normal eeg under anesthesia; normal function of the neuromuscular junction; intact right and left ulnar nerves somatosensory evoked potentials.On (b)(6) 2015: patient underwent x-ray of cervical spine due to indication of neck pain.Impression: post c4-c7 "ap" fusions without evidence of complication or significant change.On (b)(6) 2015: patient underwent ct of chest due to indication of dyspnea.Impression: no acute abnormalities are identified in the chest.Mild copd including mild emphysematous changes as well as mild chronic peribronchial thickening in the lower lung fields.There are a few strands of scarring at both lung bases but no evidence for interstitial lung disease or acute infiltrates.On (b)(6) 2015: patient underwent mri of lumbar spine with and without contrast due to indication of back pain and lumbar surgery.Impression: normal alignment.No acute fracture or spondylolisthesis.Interval revision of postoperative changes of the lumbar spine as described above.No significant enhancing granulation tissue.At l5-s1, postoperative changes.Residual posterior endplate osteophytic ridging with no narrowing of the spinal canal.Focal narrowing of the bilateral subarticular recesses with possible encroachment of the traversing s1 nerve roots.Mild narrowing of bilateral neural foramina.No spinal canal or neural foraminal narrowing at the remaining levels.Patient underwent x-ray of cervical spine due to spondylosis.Impression: post c4-c7 ap fusion without evidence of complication or change.
 
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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 Key4894208
MDR Text Key6540461
Report Number1030489-2015-01386
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
Report Date 04/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2015
Device Catalogue Number7510200
Device Lot NumberM111302AAG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/08/2015
Initial Date FDA Received07/07/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/05/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/17/2013
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 Weight88
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