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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 Neuropathy (1983); Pain (1994); Seroma (2069); Stenosis (2263); Numbness (2415); Neck Pain (2433); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2007 the patient underwent spine fusion surgery on the lumbar region at levels l5- s1.The patient was implanted with select parts of rhbmp-2/acs (i.E.Only the rhbmp-2 and collagen sponge) which was applied from a posterior approach.The rhbmp-2 collagen sponge was placed outside a cage (i.E.In the posterolateral gutters).Post-op, the patient complained of progressively worsening pain in his low back, groin, flank, and lower extremities, with associated radiculopathy into his lower extremities.Patient also underwent two revision surgeries due to severe pain and symptoms.Patient still continues to experience severe and unrelenting pain in his low back, pelvis, and bilateral lower extremities.Patient experiences difficulty standing and walking.These serious injuries prevent patient from practicing activities of daily life 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).
 
Event Description
It was reported that on: (b)(6) 2003: the patient underwent mri cervical spine.Impression: cervical spondylosis most pronounced from c5 through c7.Significant bilateral neural foraminal stenosis at c5-6.On (b)(6) 2003: the patient underwent spinal tap.The patient underwent mri angio brain wo contrast.Impression: no evidence.On (b)(6) 2003: the patient presented for a follow up for lower back pain.Impression: nonspecific headaches, post-lp headaches, improved, migraines.On (b)(6) 2006: patient underwent x-ray of the lumbar spine.Impression: status post l4-l5 disc arthroplasty and mild djd of the si joints.Patient presented with some numbness in the right toe.On (b)(6) 2006: patient presented for follow-up which reveals that facet had become big, arthritic with bone spur.On (b)(6) 2007: patient underwent ct of the lumbar spine without contrast.Impression: postsurgical changes at l5-s1 with no fracture.Artifacts emanating from the hardware make evaluation of the soft tissues.No obvious large disc herniation was noted.A small bulging disc was noted at l4-5.The remainder of the disc spaces was unremarkable.On (b)(6) 2007: patient underwent medial branch block lumbar spine at l4 bilaterally, l5 bilaterally (innervating the l5-s1 facet joint).On (b)(6) 2007: the patient underwent mri of lumbar spine w/wo contrast.Impression: increase of left sided annular tear with impingement upon the existing nerve root.Possible superimposed disc herniation.On (b)(6) 2007: patient presented with chronic back pain.On (b)(6) 2007: patient presented with pre-op diagnosis: degenerative disc disease l5-s1.Procedure: minimally invasive posterior spinal fusion l5-s1.Minimally invasive instrumentation l5-s1.Use of morselized allograft and bmp, use of fluoroscopy.Implants: expedium titanium(depuy-spine).Per-op notes: ¿¿¿.The bmp which has been prepared ahead of time with the sponge and some allograft is placed laterally to the bone and second layer of allograft is placed on the top.The final x-ray ap and lateral confirm the good positioning of the implants¿¿.No intra-operative complications were reported.On (b)(6) 2007: through telephonic conversation, patient complained of fever, pain.On (b)(6) 2007: patient presented for follow-up.Impression: severe pain.On (b)(6) 2007: the patient presented for a follow up.Impression: severe pain two weeks status post fusion, doing well though.On (b)(6) 2007: patient presented with pain across the incision.Patient underwent x-ray of the lumbar spine.Impression: stable postoperative changes at l5-s1.On (b)(6) 2008: patient underwent x-ray of the lumbar spine.Impression: stable postoperative changes at l5-s1.On (b)(6) 2008: the patient underwent radiology.Impression: increased activity involving bilateral facet joints of l5-s1 which may represent a form of pseudoarthrosis.Increased activity at the insertion of the surgical screws with no evidence of hardware loosening.On (b)(6) 2008: patient presented with failed fusion at l5-s1.Procedure: exploration of fusion.Removal of hardware.Posterior spinal fusion.Instrumentation at l5-s1 and iliac bone graft.The patient was brought to the recovery room in stable condition.On (b)(6) 2008: patient underwent x-ray of the lumbar spine.Impression: no significant interval change.On (b)(6) 2008: patient presented with severe pain in right groin area through telephonic conversation.On (b)(6) 2008: patient presented with discomfort in lower back incision area, pain over the right hip that radiates onto the right groin and right thigh area.On (b)(6) 2008: patient underwent physical therapy, but the pain was still there.Patient underwent ct scan of the lumbar spine.Impression: increased activity involving bilateral facet joints of l5-s1 which may represents pseudoarthrosis.No evidence of hardware loosening or failure.On (b)(6) 2008: patient presented with decrease in the accumulation of the fluid.There is soreness around the incision line.On (b)(6) 2008: patient presented with follow-up.Patient underwent x-ray of the lumbar spine.Impression: spinal fusion of l5-s1, unchanged.On (b)(6) 2008: the patient presented for a follow up.Impression: status post lumbar fusion, doing better.On (b)(6) 2008: patient presented with some intense pain and swelling at the site.On (b)(6) 2008: patient presented with acute back pain, swelling in the surgical area.Swelling has resolved now.X-rays showed no loosening of the screws, bone placed posterolaterally seems to be totally healed.Patient underwent x-ray of the lumbar spine.Impression: spinal fusion of l5-s1, stable examination.On (b)(6) 2008: patient presented with acute pain in his low back.On (b)(6) 2008: the patient presented for a follow up.Impression: left si joint pain post fusion.Otherwise doing well.Still high dose narcotics.On (b)(6) 2008: the patient underwent sacroiliac joint injection left with fluoroscopy.On (b)(6) 2008: patient presented for follow-up.Patient presented with some left sacroiliac joint pain.X-rays showed perfectly healed fusion on both sides.Patient underwent x-ray of the lumbar spine.Impression: spinal fusion of l5-s1, unchanged.On (b)(6) 2008: the patient presented for a follow up.Impression: post- laminectomy fusion syndrome, stable.On (b)(6) 2009: the patient presented for a follow up.Impression: severe chronic pain, improved.On (b)(6) 2009: the patient underwent radiofrequency ablation sacroiliac joint, left, under fluoroscopic guidance.On (b)(6) 2009: patient presented with new back pain.On (b)(6) 2010, (b)(6) 2009, (b)(6) 2007: the patient presented for a follow up.Impression: severe chronic pain.22 jun 2010: the patient presented for a follow up.Impression: failed back fusion syndrome.On (b)(6) 2010: the patient underwent mri cervical spine w/o contrast due to neck pain.Impression: mild moderate multilevel cervical spondylosis.On (b)(6) 2010: the patient underwent ct lumbar spine, post myelogram.Impression: unremarkable postoperative ct study, status post laminectomy and fusion at l5-s1.Correlation with surgical history is necessary to determine if the lucent and sclerotic lesion in the left iliac bone is iatrogenic or possibly represents a neoplasm of the cartilaginous or osseous origin.On (b)(6) 2010: the patient presented for a follow up.Impression: severe chronic pain post multiple back surgeries.On (b)(6) 2011: the patient presented for a follow up.On (b)(6) 2011, (b)(6) 2010: the patient underwent trigger point injections.On (b)(6) 2011: the patient presented for a follow up.Impression: severe and chronic pain.On (b)(6) 2012: patient developed increasing pain on the, left flank greater than right flank, as well as pain travelling down the posterior aspect of his lower extremities in a claudication-type fashion.On (b)(6) 2012, (b)(6) 2010: the patient presented for a follow up.Assessment: severe chronic back pain status post lumbar laminectomy and lumbar fusion.On (b)(6) 2012: the patient underwent mri thoracic spine without contrast.Impression: mild diffuse disc degeneration in the thoracic spine.No thoracic disc herniation or other compressive lesion.Degenerative disc changes in the cervical spine.On (b)(6) 2012: the patient underwent trigger point injections left upper thoracic spine.On (b)(6) 2012: the patient underwent trigger point injections, left low back.On (b)(6) 2012: patient underwent ct scan of the pelvis without contrast.Impression: computed tomography of the pelvis demonstrates lumbosacral fusion with instrumentation.There is no fracture.Patient underwent ct spine lumbar without contrast.Impression: mild to moderate canal stenosis.L4-5 : united bilateral lateral spine fusion with instrumentation without hardware complication.Total disc prosthesis in anatomic position without radiographic abnormality.Patient underwent ap and lateral view of the lumbar spine.Impression: bilateral lateral spine fusion at l5-s1 with instrumentation.Total disc prosthesis in anatomic position in l5-s1.Patient underwent ap of the pelvis.Impression: bilateral lateral spine fusion and total disc prosthesis at l5-s1.Donor graft site in the posterior medial aspect of left iliac bone.The patient underwent x-ray of lumbar spine.Impression: bilateral lateral spine fusion at l5-s1 instrumentation.Total disc prosthesis in anatomic position in the l5-s1.The patient underwent x-ray of pelvis.Impression: bilateral lateral spine fusion and total disc prosthesis at l5-s1.Donor graft site in the posterior medial aspect of the left iliac bone.The patient underwent ct of pelvis.Impression: computed tomography of the pelvis demonstrates the lumbosacral fusion with instrumentation.The patient underwent ct spine lumbar w/o contrast.Impression: l4-5- mild to moderate canal stenosis.L5-s1- united bilateral lateral spine spine fusion with instrumentation without hardware complication.Total disc prosthesis in anatomic position without radiographic abnormality.On (b)(6) 2013: patient underwent mri of the lumbar spine.Impression: moderate left and mild facet joint arthrodesis without stenosis.L5-s1: operative changes related to the disc replacement and instrumented posterior fusion.There is no stenosis or nerve root impingement.The position of the hardware and integrity of the arthrodesis are better evaluated on the recent scan.On (b)(6) 2013: patient presented with back pain, left flank greater than right flank pain.Bilateral lower extremity claudication-type pain from posterior thighs to calf.Patient has the great toe numbness.Radiographs reveal arthrodesis at l5-s1 with significant lateral bridging bone.Patient has mild degenerative changes at l4-5.On (b)(6) 2013: the patient presented for a follow up.Assessment: severe back and leg pain status post multiple spine surgeries.On (b)(6) 2013: the patient presented for a follow up.Assessment: severe primarily low back pain status post lumbar fusion.On (b)(6) 2013: the patient underwent trigger point injection left paraspinous thoracic muscles.On (b)(6) 2013: the patient presented for a follow up.Assessment: severe primarily low back pain status post lumbar fusion.On (b)(6) 2013: the patient underwent trigger point injection left quadratus lumborum.On (b)(6) 2013: the patient presented for a follow up.Assessment: severe chronic failed back syndrome on moderate narcotic, worsening.The patient underwent mri lumbar w/wo contrast.Impression: straightening of the lumbar lordosis with a mild disc herniation of l1-l2 lateralizing toward the left with indentation on the ventral left aspect of the sac with no evidence of the compromise of the cauda equine.The patient underwent mri lumbar flexion and extension.Impression: mild disc herniation of l1-l2 lateralizing toward the left with no evidence of the compromise of the cauda equine.On (b)(6) 2014: the patient presented for a follow up.Assessment: severe left low back/flank pain-unclear etiology.On (b)(6) 2014: the patient underwent facet injections, left l5-s1 and l4-l5 with fluoroscopic guidance.Impression: severe left low back pain, flank pain as well.On (b)(6) 2014: the patient presented for a follow up.Assessment: severe left low back and hip pain.New l1-2 disc herniation on mri.On (b)(6) 2014: the patient underwent transforaminal epidural left at l1-l2 with fluoroscopic guidance due to mild to left back, buttocks pain.Impression: new lumbar disc herniation.On (b)(6) 2014: the patient underwent left transforaminal epidural at l1-l2 with fluoroscopic guidance due to mild to left back, buttocks pain.Impression: new lumbar disc herniation.On (b)(6) 2014: the patient presented for a follow up.Assessment: severe left flank pain, disc herniation l1-2.On (b)(6) 2014: the patient underwent mr lumbar / sacral spine.Impression: post surgical changes within the lumbar spine at l5-s1.Shallow left paracentral disc herniation l1-2 with deformity on the thecal sac.Annular disc bulging at l4-l5 with encroachment of the inferior neural foramina.On (b)(6) 2014: the patient presented for a follow up.He complained of significant back pain.Assessment: severe chronic failed back syndrome maintain on narcotic analgesic, undergoing therapy.On (b)(6) 2014: the patient underwent ct lumbar spine w/o contrast.Impression: since (b)(6) 2010 redemonstrated is the posterior metallic fixation between l5 and s1 without evidence for a screw fracture, migration or loosening.There is also bony fusion between the l5-s1 facet joints.Redemonstration of the l5-s1 intervertebral disc prosthesis in the slight grade 1 anterospondylolisthesis at l5-s1.No disc herniation.New since the prior study is mild loss of height with endplate osteophyte formation at l4-5 and erosions into the adjacent endplate more severely involving the inferior endplate of l4 than the superior endplate of l5.These finding raise the possibility of infection(discitis).On (b)(6) 2014: the patient presented for a follow up.Assessment: severe failed back syndrome, question of endplate erosion.On (b)(6) 2015: the patient presented for a follow up for severe chronic pain.Assessment: severe chronic back pain, question of loosening pedicle screws.On (b)(6) 2015: patient presented with degenerative disc disease.Junctional syndrome.Procedures: anterior lumbar discectomy.Anterior lumbar spinal fusion (left lateral approach).Insertion of a cage anterior instrumentation.Use of allograft and bmp.Levels: l4-l5.Per-op notes: ¿¿.The cage is packed with bmp and allograft and inserted under visual control until the distal part of the cage is well placed between cortic bones on the other side¿¿.Patient was brought to recovery room in stable condition.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on: (b)(6) 2007: the patient presented with the facet arthritis.The patient underwent posterior spinal fusion at l5-s1 with instrumentation, rhbmp-2/acs and autograft cancellous chips.
 
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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 Key4893732
MDR Text Key20037275
Report Number1030489-2015-01368
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
Report Date 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/01/2010
Device Catalogue Number7510200
Device Lot NumberM110701AAA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/21/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/11/2007
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) Required Intervention;
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