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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 Aspiration Issue (2883)
Patient Problems Bowel Burn (1756); Stenosis (2263); Neck Pain (2433); Disc Impingement (2655)
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
It was reported that per medical records on (b)(6) 2006, the patient underwent a mri scan of cervical spine and lumbar spine with and without contrast due to c6-c7 degenerative disc disease and lumbar herniation nucleus pulposis.Impression: moderately severe degenerative disc changes c5-c6 with loss of disc height, (055 of disc signal, circumferential annular bulging and mild minimal spinal stenosis.Regular annular bulging principally centrally at c5-c6 without significant spinal stenosis.Impressions: advanced degenerative disc changes at l3-4 with loss of disc height, degeneration of the nucleus, associated discogenic sclerosis of the opposing vertebral bodies and minimal annular bulging.The remainder of the lumbar disc is intact and there is no evidence of spinal stenosis, herniated disc fragment, or nerve root compression.On (b)(6) 2006, the patient presented for followup with complaints of cough.On (b)(6) 2006, the patient underwent a whole body scan due to pain.Impressions: abnormality seen in thoracic spine and lumbar spine at the levels described which are associated with degenerative disc changes and reactive sclerosis on plain radiographs.No other significant areas of osteoblastic activity.The patient also underwent a mri of thoracic spine without contrast.Impression: focal left para-central disc protrusion.T7-8 which slightly deforms the left side of the cord at this level even though there is not significant spinal stenosis.Mild spondylosis and annular bulging at t8-9.Right para-central protrusion of disc material t9-10 without spinal stenosis or deformity of the cord.On (b)(6) 2007, the patient presented for followup with complaints of pain in her back with pain radiating down both legs, left greater than right alone with some weakness in her legs.Impression: lumbar disc disease; hypertension; history of hepatitis c; status post breast reduction; status post lumbar spine surgery; history of left shoulder surgery; history of carpal tunnel syndrome; family history of hypertension, stroke, cancer, and depression; history of sinusitis.History of pneumonia; history of rectal bleeding with negative colonoscopy; history of urinary tract infection; polyarthralgias; history of migraine headaches; history of depression.On (b)(6) 2007, the patient was admitted for treatment of thoracic spondylosis with facet arthropathy, neural foraminal stenosis from t7 to t10, disk herniation right t9-10 and degenerative disk disease t7 to t10 with bilateral thoracic radiculopathy.The patient underwent a surgery with diagnosis of thoracic degenerative disk disease, herniated nucleus pulposus, thoracic t9, t10, stenosis, thoracic.Procedure: t7 to t10 posterior thoracic fusion; t7 to t10 internal fixation with a roc plate system; bone graft harvest, local, plus bone marrow harvest, bilateral iliac crest.No patient complications.The patient also had an x-rays of thoracic spine in 1 view intra-op.On (b)(6) 2007, the patient underwent a ct pulmonary embolism with contrast with reason of "pe sob tachy".Impression: some limitations as above, but no definite evidence of pulmonary embolism; tiny bilateral pleural effusions and mild dependent atelectasis at the lower lobes; postoperative changes as above.Also, the [patient underwent an x-ray of chest for evaluation.Impression: no acute cardiopulmonary disease identified.Postoperative changes in the thoracic spine noted.On (b)(6) 2007, the patient presented for follow-up with complaints of pain and sensation to lower rib cage area.On (b)(6) 2007, the patient presented for review of x-rays of thoracic spine in 2 views.Impressions: postoperative findings with flexion/gibbous deformity as above.The patient presented for neurosurgical followup with complaints of pain along the lumbosacral spine.On (b)(6) 2007, the patient underwent x-ray of thoracic spine in 2 views due to lumbar disk displacement.Findings: there was a kyphotic deformity of thoracic spine which was unchanged.An anterior wedge deformity of the t10 vertebral body is unchanged.The patient also presented for followup with complaints of pain in mid to lower thoracic right paraspinal region which was constantly present, unable to fully erect.On (b)(6) 2007, the patient underwent a radiograph of spine dorsal thoracic in 2 views.Impression: -old fracture of t10 with severe kyphosis of the thoracic spine and fixation of the thoracic spine by pedicular screws and interlocking bars from t7 to t10 the patient also underwent an x-ray of lumbar spine in 2 or 3 views.Impressions: severe degenerative changes of the intervertebral disc at l3-l4.Otherwise negative lumbar spine.On (b)(6) 2007, the patient presented for orthopedic spinal evaluation with complaints of bas chest infection dn pain in the mid-thoracic region with a clearly increasing kyphotic deformity.On (b)(6) 2008, the patient underwent xray of lumbar spine in ap, lateral, flexion and extension views.Impression: focal degenerative disc changes at l3-4.The patient presented for neurosurgical followup with complaints of pain in lower thoracic and thoracolumbar region, neck and right shoulder.On (b)(6) 2008, the patient underwent a surgery with diagnosis of degenerative disk disease status post t7 to t10 thoracic fusion, compression fracture t10, kyphotic thoracic deformity.Procedure: partial explanation of internal fixation with exploration of fusion mass; anterior thoracotomy (t10) with hemicorpectomy of t10-t11, interbody fusion, t10-t11 with harms cage; internal fixation with depuy bowtie fixation; bone graft, auto graft structural rib; posterior lateral fusion, t9 to l2; internal fixation from t7 to l2 with the roc rod system; reduction of thoracic kyphotic deformity; bone graft local plus bone marrow harvest (240 cc).Per op-notes, bone marrow was harvested, a total of 240 cc, split between the two iliac crests.This was processed by the fusionary system for stem cell concentration.Stem cells were added to the crushed cancellous allograft.In addition, there was a small amount of local bone which had been debrided of soft tissue and morcellized.We also had used bone morphogenetic protein and put a single sponge into the anterior carpectomy site.An osteotomy was now carried out at the t10 level in order to facilitate correction of the kyphotic deformity.We had a partial correction after the anterior carpectomy and i then cut two quarter inch rods to appropriate length, bent them to the appropriate degree of kyphosis.I under bent the rods in order to utilize the rods as part of the correction of the kyphotic deformity.I then secured the rods to the inferior pedicle screws t12, l1 and l2 and then cantilevered them down into place, securing them to the upper pedicle screws with slotted connectors.Bone graft had been packed into the lateral gutters and the facet joints.This was local bone as well as stem cell bone.No patient complications.The patient underwent another surgery with diagnosis of anterior wedge compression; fracture, t10; kyphotic spinal deformity, severe, tl0-t11; previous t7 to t10 laminectomy, posterior spinal fusion with roc pedicle screw instrumentation system.Procedure: explanation of posterior segmental instrumentation t7 to t10, (roc plates); exploration of spinal fusion; right t10 thoracotomy, right t10 rib harvest, partial carpectomy, t10 and t11, anterior interbody fusion with harms cage, autologous rib grafts and bone morphogenic protein, t10-t11; re-exploration, foraminotomy, laminotomy, bilateral t10, pedicle suppression osteotomy, bilateral t10, posterolateral fusion with autologous bone marrow stem cells, t10 through l2, roc rod pedicle screw instrumentation t7 to l2 with complete correction of kyphotic spinal deformity.Per op- notes, dr.(b)(6) then performed an interbody fusion with a preformed medium/large cage packed with vertically oriented autologous rib graft pieces; this was impacted most securely.The points on the cages, very securely anchored the cage in place.Any further impaction may have resulted in fracture of the vertebral bodies; it was very secure.We packed the space between the cage and the posterior cortical shell of bone on the anterior aspect of the spinal canal with further rib struts.A pledget of bone morphogenic protein was placed in to this region also.Dr.Johnson then added a kick plate for security to keep the cage from migrating.No patient complications.The patient underwent another surgery with diagnosis of compression fracture with kyphotic spinal deformity of t10.Procedure: t10 carpectomy.Placement of harm's cage with autologous rib graft material with placement of bow-tie.Fluoroscopic confirmation.No patient complications.On (b)(6) 2008, the patient underwent an xray of lumbar and thoracic spine in ap and lateral view.Impression: status post extensive thoracolumbar fusion procedure with stable postoperative changes compared to previous examination.The patient also presented for followup with complaints of pain in hips.On (b)(6) 2008, the patient underwent xray of lumbar spine in 2 views and of thoracic spine in 2 views.Impression: status post extensive thoracolumbar fusion with stable postoperative changes compared to previous examination.The patient presented for neurosurgical follow-up with complaints of low back pain, pain radiating into the hips and into the lateral aspect of the right thigh.On (b)(6) 2008, the patient presented for a followup with complaints of low back pain, right sided leg pain in anterior and lateral thigh.On (b)(6) 2008, the patient underwent a surgery with diagnosis of degenerative disk disease, l3-4; facet arthropathy with lumbar radiculopathy; segmental instability.Procedure: partial exploration of fusion mass, l1-2; laminectomy l3, l4 with decompression of the neural elements; posterior lumbar interbody fusion at l3 -4 (10 mm tlif cage); lj, l4 posterolateral fusion with facet fusion; l3, l4 internal fixation with the roc plate system; bone graft local plus bone marrow as pi rate (180 cc).No patient complications.The patient also underwent a xray of lumbar spine ina single view intra-op.The patient was discharged the same day.On (b)(6) 2008, the patient underwent an x-ray of lumbar spine in 2 views due to lumbar and lumbosacral disk degenerative disease.Impression: status post extensive thoracolumbar fusion extending to the l2 level with recent addition of additional lumbar fusion l3-4.Exam is remarkable for suspected fracture involving the posterior superior aspect of the l3 vertebral body extending into the l3 superior endplate.The patient also presented for followup for radiograph evaluation.On (b)(6) 2009, the patient underwent x-ray of lumbar spine in 3 views due to lumbar and lumbosacral disc degenerative disease.Impression: multilevel thoracic and lumbar fusion procedures with stable appearance compared to (b)(6) 2008.The patient also presented for followup with complaints of back pain.On (b)(6) 2009, the patient underwent x-rays of lumbar spine in 3 views due to back pain.Impression: status post multilevel thoracic and lumbar fusion procedures with stable appearance compared to previous examination.The patient also underwent x-rays of complete cervical spine.Impression: multilevel degenerative changes most marked at c6-7.The patient also presented for follow-up with complaints of neck pain.On (b)(6) 2009, the patient underwent a surgery with diagnosis of status post fusion from thoracic down to l2 1 and l3 to l4; kyphotic deformity l2-l3; spinal stenosis; segmental instability.Procedure: partial explantation of internal fixation with exploration of fusion mass; laminectomy l2-3 and l3-4 with decompression of the neural elements; l2-l3 posterior lumbar interbody fusion using cages (12.0 x 12.0 x 2 5.0 111111 and 12.0 x 12.0 x 21.0 mm); l2 to l4 internal fixation with the roc-plate-rod system; correction of kyphotic deformity; bone graft local plus bone marrow aspirate (240 cc).The patient also underwent an x-ray of lumbar spine in lateral view intra-op during surgery.On (b)(6) 2009, the patient was discharged.On (b)(6) 2009, the patient underwent x-ray of lumbar spine in 2 views due to lumbar disk degenerative disease.Impression: status post extensive thoracolumbar fusion with recent surgical revision involving the l2 through l4 levels.The patient also presented for follow-up.On (b)(6) 2009, the patient presented for evaluation with complaints of pain.Review of systems showed positive for chronic constipation, painful bowel movement, chronic cough, decreased libido, and painful joints.Assessment: chronic low back pain after previous several back surgeries and thoracic surgeries; cervical radiculopathy.On (b)(6) 2009, the patient underwent a mri of cervical spine in sagittal and axial, partial flip, fse t2 and sagittal t1 views due to neck pain.Impression: posterior-central and right paracentral disc protrusion measuring 2.97 mm c5-c6 with thecal sac impingement; posterior central and right paracentral disc protrusion measuring 2.49 mm c3-c4 with thecal sac impingement; posterior central disc protrusion c4-c5 with thecal sac impingement; posterior central disc bulge c2-c3, and severe disc narrowing with posterior disc bulge c6-c7.On (b)(6) 2010, the patient underwent an x-ray of lumbar spine in ap, lateral and spot views due to stenosis.Impression: status post extensive thoracolumbar fusion procedure with stable appearing lumbar spine compared to previous examination.The patient also presented for followup with complaints of neck pain, pain radiating down into both arms, the right arm greater than the left.On (b)(6) 2010, the patient underwent a mri scan of left shoulder with indication of pain.Impression: low-grade partial-thickness undersurface tear suspected about the insertional fibers of the supraspinatus and infraspinatus tendons; interstitial degeneration f the intra-articular segment of the biceps tendon; acromioclavicular and glenohumeral joint osteoarthritis; questionable surgical artifact over the subcutaneous tissues of the shoulder joint.On (b)(6) 2010, the patient underwent xrays for lumbar region in ap, lateral and spot views.Impression: status post extensive thoracolumbar fusion with stable postoperative changes compared to previous examination.Also, the patient underwent a complete cervical spine xray.Impression: stable degenerative changes of c6-7.The patient presented for followup with complaints of pain developing into the right buttock and hip.On (b)(6) 2010, the patient underwent a mri scan of lumbar spine without and with iv contrast due to lumbar and lumbosacral and cervical disk degeneration.Impression: no definite acute abnormality; compromise of right lateral recess, moderate in degree, from hardware at l2-3 level, without definite change from prior plain film studies; epidural fibrosis along surgical pathways, particularly left lateral recess l3-4.This involves the traversing left l3 and originating left l4 nerve roots.Mri of the cervical spine showing mild spondylosis of the cervical spine.This is more pronounced at the c5-c6 where there is narrowing of the disc space and anterior and posterior spur formation causing mild impression on the anterior and right anterolateral aspect of the thecal sac.Minimal central spur formation is noted at the c4-c5 and c5-c6.This causes minimal narrowing of the neural foramina in the right side at the c5-c6.There is no evidence of myelomalacia.There is no central spinal canal stenosis.On (b)(6) 2010, the patient presented for followup with complaints of back pain.On (b)(6) 2012, the patient underwent a ct scan of the lumbar spine with reconstructions due to pain.Impressions: failed hardware and fusion are or at l1-2 and l2-3.Disrupted attachment pedicle screws and posterior instrumentation.Recommend plain radiographic correlation for details however there appears to be disruption of the right l2 pedicle screw attachment into steffey plate instrumentation and fracture of the fixation rod extending into the thoracic spine.Pseudo arthrosis of the posterior fusion at both l1-2 and l2-3 with gibbus deformity.Nonunion of the anterior fusion at l2-3 with retropulsion of the cage type implant at l2-3 on the right with compression of the right l2 and l3 nerve roots.On (b)(6) 2012, the patient presented for follow-up with complaints of pain in her neck, both arms, back, right and left leg.The patient's ct scan and x-rays were reviewed that showed a complete reversal of her lumbar lordosis to almost 60 degrees of kyphosis from her lower thoracic down to her sacrum.On (b)(6) 2013, the patient underwent x-rays of thoracic and lumbar spine with indications of low back pain radiating to the bilateral dorsal lower extremities.Impressions: moderate biforaminal stenosis at t10-t11, l2-l3 and l5-s1 and moderate narrowing of the right lateral recess at l2-l3.Status post thoracolumbar spine fusion with anterior wedge compression of the l1 vertebral body that is new since prior study.On (b)(6) 2013, the patient presented for followup with complaints of back pain and stenosis.The patients x-rays showed that the hardware had disassembled to some degree and she has a very significant upper lumbar kyphotic deformity which was leaving her bent forward almost 90 degree clinically.The patient's xrays were also reviewed and showed 55 degree kyphotic deformity between the lower endplate of l4 and the upper endplate of l1.The ct myelogram showed some neural foraminal stenosis at multiple levels in the lower thoracic region and also in the lumbosacral junction.The majority of her deformity occurred at l2-3 which was the level where her previous interbody fusion cage was placed.
 
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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 Key5052649
MDR Text Key24923814
Report Number1030489-2015-02193
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
Report Date 08/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Expiration Date03/01/2010
Device Catalogue Number7510600
Device Lot NumberM110610AAJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/03/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/31/2007
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) Other;
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