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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 Arthritis (1723); Headache (1880); Incontinence (1928); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Seroma (2069); Weakness (2145); Stenosis (2263); Injury (2348); Neck Pain (2433)
Event Type  Injury  
Manufacturer Narrative
(b)(4).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 (b)(6) 2005 the patient was presented for office visit with back pain and leg symptomatology.Diagnosis: l3-4 lateral listhesis.Thirty-five (35) degree lumbar curve.Right l4-5 and l5-s1 disc herniation.Right s1 radiculopathy.Severe foraminal stenosis at l1-2, l3-4, l2-3, l4-5.Discogenic back pain, severe foraminal stenosis, lumbar instability and dextroscoliosis.On (b)(6) 2006 the patient underwent mri of the lumbar spine due to severe back pain.Impression: degenerative disc disease is seen throughout.Lateral interforaminal herniation to the right at l3-4 and l4-5 causes marked neural foraminal compromise and nerve root impingement.At l5-s1, similar findings are seen with disc and spur narrowing the right-sided neural foramen and compromising the right l5 root.On (b)(6) 2006, patient underwent mri of lumbar spine due to severe back pain.Impression: degenerative disc disease is seen throughout.Lateral interforaminal herniation to the right at l3-4 and l4-5 causes marked neural foraminal compromise and nerve root impingement.At l5-s1, similar findings are seen with disc and spur narrowing the right sided neural foramen and compromising the right l5 root.No enhancing lesion is seen.On (b)(6) 2006, patient presented for office visit with chief complaint of back pain and leg symptomatology.Physical examination: constitutional: the patient was right handed.Patient was pleasant and looked the stated age.(b)(6); musculoskeletal and neurological: the patient's posture was normal.The patient's gait was normal.The patient had normal toe, heel and tandem walking.There were no non-organic signs.On (b)(6) 2006, patient presented for evaluation of low back pain radiating into her legs for past one year.Patient reported weakness in right lower extremity and bilateral feet numbness.Impression: lumbar radiculopathy.Patient underwent electromyographic examination due to low back pain and leg pain.Impression: this is a normal emg/nerve conduction study of bilateral lower extremities.By this test there is no evidence of neuropathy or radiculopathy.On (b)(6) 2006, patient underwent lumbar myelogram due to scoliosis.Impression: degenerative changes causing impressions on the contrast column at multiple levels.This will further be evaluated with ct of the lumbar spine to follow.Patient underwent ct of lumbar spine without contrast due to scoliosis.Impression: spondylotic changes cause mild to moderate impressions on the thecal sac as well as mild neural foraminal narrowing at multiple levels of the lumbar spine.There is no evidence of canal stenosis at any lumbar vertebral body level.On (b)(6) 2006 the patient underwent ct scan of the lumbar spine.Impressions: spondylotic changes as described above causing mild to moderate impressions on the thecal sac as well as mild neural foraminal narrowing at multiple levels of the lumbar spine as described above.There is no evidence of canal stenosis at any lumbar vertebral body level.On (b)(6) 2006 the patient underwent x rays of the lumbosacral spine due to back pain.Findings: there is marked scoliosis lumbar spine convexity to the right.There are considerable degenerative changes about the lumbar spine with narrowing of all of the intervertebral disc spaces.The body of l2 lies slightly ventral to l1 and the body of l3 lies slightly ventral to l2.The body of l5 lies slightly ventral to l4 and this is all felt to be related to the scoliosis.On (b)(6) 2006, patient underwent radiographic study of lumbosacral spine due to complaint of back pain.On (b)(6) 2006, patient underwent following procedure: far lateral decompressive discectomy, right l3-4 and right l4-5; lumbar de compressive laminectomy, l2, l3, l4, l5 and s1; single posterior incision anterior column and posterior column arthrodesis l2 to s1 with insertion of anterior biomechanical devices at each level from l2 to s1; posterolateral fusion, t12 to s1; pedicle screw instrumentation; local autograft utilization; ssep, emg monitoring for six hours; use of bone morphogenic protein; use of microscope; intrathecal administration of morphine; for pre-op diagnosis of: degenerative scoliosis; lumbar spinal stenosis; far lateral disc herniation, right l3-4, l4-5.Findings: far lateral disc herniation, right l3-4, l4-5; degenerative scoliosis with lateral recess stenosis.As perop-notes: ".Bilateral discectomy was subsequently performed from l2-3, l3-4, l4-5, l5-s1.We inserted three 15mm cages on the right l3-4, l4-5 and l5-s1 and on left at l2-3.Posterolateral fusion was subsequently carried out with decortication of facets and posterolateral gutters.We packed in local autograft bone and bmp to achieve posterolateral fusion from t12 to s1.Bmp was also used for interbody fusion and it was packed into the peek cages mentioned previously.The patient tolerated the procedure well." on (b)(6) 2006, patient underwent radiographic study of lumbosacral spine due to spine reconstruction.Impression: a t11 through s1 spinal fusion with no complication process identified.Patient underwent radiographic study, portable intraoperative lateral lumbar spine.On (b)(6) 2006, patient underwent following procedure: bilateral decompression with discectomy of l3-4 and l4-5, decompressive laminecntomy of l2 through s1, posterior lumbar fusion t12 to s1; for pre-op diagnosis of: degenerative scoliosis, lumbar spinal stenosis and bilateral disc herniation of l3-4 and l4-5.No complications were reported.On (b)(6) 2006 the patient presented for post-op follow-up.Patient underwent x rays of the lumbosacral spine.No complication reported.On (b)(6) 2006, patient underwent radiographic study of lumbosacral spine.On (b)(6) 2006, patient presented for office visit due to low back pain.Patient reported pain in low back, don both legs and in her buttocks and pain is worse at night.Patient underwent ct of lumbar spine without contrast due to back pain following lumbar and thoracic fusion procedure.Impression: prominent fluid collection, posteriorly in the region on the lumbar spine may represent seroma.The possibility of csf leak cannot be excluded; status post-op laminectomy and fusion procedure of t11-12 through s1 levels; mri may be of additional benefit.On (b)(6) 2006 the patient presented for post-op follow-up.Patient reported intermittent low back pain.Patient underwent x rays of the lumbosacral spine.Findings of posterior lumbar fusion noted at the levels of t12 through s1 with pedicular screws noted in place.No malalignment identified.On (b)(6) 2006, patient underwent radiographic study of lumbar spine two views.On (b)(6) 2006, patient presented for post-op follow-up.Patient reported back pain and incisional pain.On (b)(6) 2006 the patient presented for post-op follow-up.Patient underwent x rays of the lumbosacral spine.Impression: status post t12 transpedicular fusion.No change since (b)(6) 2006.On (b)(6) 2006, patient underwent x-ray of lumbar spine.Impression: status post t12 through s1 transpedicular fusion.On (b)(6) 2006, patient presented for post-op follow-up.Patient reported left sided muscle pain.Physical examination: musculoskeletal and neurological: there was normal spinal balance.Patient underwent x-ray of lumbar spine.Impression: status post fusion t12-s1.On (b)(6) 2006 the patient underwent x rays of the lumbosacral spine.Impression: postoperative changes are present.There is no change from prior exam.On (b)(6) 2007, patient underwent x-ray of lumbar spine.Impression: postoperative changes are present.There is no change from prior exam.On (b)(6) 2007 the patient underwent x rays of the lumbosacral spine.Impression: postoperative changes are present.There is no change from prior exam.On (b)(6) 2007, patient underwent ct of lumbosacral spine including sagittal and coronal reformatted images.Impression: there has been no significant changes in findings since (b)(6) 2006.Soft tissue along the left posterolateral thecal sac at l4-5 and l5-s1 is most likely related to epidural fibrosis.On (b)(6) 2007, patient presented for evaluation of ct scan of lumbar spine.Patient reported incisional pain.On (b)(6) 2007, patient presented for evaluation after physical therapy.Physical examination: musculoskeletal and neurological: there was normal spinal balance.Patient underwent radiographic study of lumbosacral spine due to pain and postop.On (b)(6) 2008 the patient was presented for office visit with low back pain.On (b)(6) 2008, patient presented for office visit due to back pain with incontinence.Patient underwent mri of lumbar an thoracic spine with and without contrast for history of incontinence.Impression: there is fluid collection at the laminectomy site.The spinal canal and conus medullaris cannot be evaluated secondary to the artifact from hardware.On (b)(6) 2008, patient underwent lumbar myelogram due to continued intractable back pain.Impression: non-complicated lumbosacral my elography; t12 through s1 spinal fusion with bony ankylosis at the l3-4, l4-5 and l5-s1 levels.Patient underwent ct of lumbar spine with contrast due to intractable back pain with previous spinal fusion.Impression: extensive thoracolumbar spinal fusion from the t12 through s1 level with mild levoscoliosis.There is no evidence for neural foraminal or central canal stenosis.On (b)(6) 2008, patient presented for post-op follow-up.Patient reported continued back pain.On (b)(6) 2008 the patient was presented for office visit with left sided low back pain.Diagnosis: status post thoracolumbar laminectomy and fusion from t12 to s1.On (b)(6) 2008, patient underwent following procedure: removal of pedicle screws and rods, nonsegmental left; exploration of lumbar fusion; use of fluoroscopy; for pre-op diagnosis of: post-laminectomy syndrome and chronic low back pain.Findings: completely fused segment, l5-s1.No complications were reported.On (b)(6) 2008 the patient was presented for office visit with postoperative appointment.Diagnosis: status post thoracolumbar fusion from t12 to s1.Status post percutaneous removal of hardware at left l5-s1.On (b)(6) 2008 the patient underwent removal of pedicle screw and rod, non segmental left.Exploration of lumbar fusion.Use of fluoroscopy.Preoperative diagnosis: post laminectomy syndrome and chronic low back pain.On (b)(6) 2008, patient underwent radiographic study of lumbar spine.The patient was presented for office visit with left-sided low back pain.Diagnosis: status post thoracic fusion to t12 to s1.Status post percutaneous removal of hardware on the left at l5-s1.On (b)(6) 2008, patient underwent electromyographic examination due to low back pain and status post spinal fusion 1.5 years ago.Impression: this is a normal emg/nerve conduction study of bilateral lower extremities.By this test there is no evidence of neuropathy or radiculopathy.On (b)(6) 2008, patient underwent ct of pelvis without contrast due to pain.Impression: post-operative and degenerative changes without evidence of acute fracture.On (b)(6) 2009, patient underwent mri of lumbar spine with and without contrast due to lumbar radiculopathy.Impression: post-operative changes related to thoracic, lumbar and sacral fusion.Previously demonstrated fluid collection within the surgical bed remains unchanged.Apparent right l5 nerve root abutment by the para pedicular /paravertebral body screw.On (b)(6) 2009, patient underwent ct of lumbar spine with and without contrast due t radiculopathy post-op lumbar fusions.Impression: 1.Interval revision of the posterior fusion at l5-s1.There is no evidence of residual central canal stenosis at any level.On (b)(6) 2009, patient underwent nm bone spect due to back pain s/p fusion disc stress fx.Impression: spect ct fusion examination reveals increased uptake at t11 and at the left pedicle of l4.I suspect a healing rib fracture involving the right anterior 8th rib.On (b)(6) 2009, patient underwent following procedure: excision of atrophic skin, excision of neuroma, sacroiliac joint injection; for pre-op diagnosis of: cluneal nerve neuroma.The patient tolerated the procedure well.On (b)(6) 2009, patient presented for reevaluation of seizures, headache and neck pain.Patient reported leg weakness and legs giving out.Impression: seizure disorder, stable; headaches, stable; neck pain with spinal stenosis by mri.On (b)(6) 2009 the patient was presented for office visit.Diagnosis: status post thoracolumbar laminectomy and fusion t12 to s1.Status post removal of hardware of l5-s1.Junctional deterioration at t11-t12.Possible left s1 joint dysfunction.On (b)(6) 2009, patient underwent ct of thoracic spine without contrast due to pain.Impression: postoperative changes are present.On (b)(6) 2009 the patient was presented for office visit for evaluation of imaging study.Diagnosis: status post thoracolumbar laminectomy and fusion t12 to s1.Status post removal of hardware of l5-s1.Junctional deterioration at t11-t12.Possible left s1 joint dysfunction.On (b)(6) 2009, patient underwent electromyographic examination due to low back pain.Impression: this is a normal emg/nerve conduction study of bilateral lower extremities.By this test there is no evidence of neuropathy or radiculopathy.On (b)(6) 2010, patient underwent mri of lumbar spine with and without contrast.Impression: posterior fusion and extensive metallic artifact without significant abnormality.On (b)(6) 2011, patient underwent radiographic study of lumbosacral spine.Impression: status post thoracolumbar laminectomy ad fusion from t12 to s1; status post removal of hardware at left l5-s1.On (b)(6) 2011 the patient was presented for office visit for evaluation after imaging study.Diagnosis: status post thoracolumbar laminectomy and fusion t12 to s1.Status post removal of hardware of l5-s1.Junctional deterioration at t11-t12.Possible left s1 joint dysfunction.On (b)(6) 2011, patient underwent ct of lumbar/thoracic spine with contrast.Impression: postsurgical changes are seen from t12 through s1.There is a mild dextrocurvature.There is no disc herniation.Mild disc bulging is seen at the t10-11 and t11-12 levels.There is right neural foraminal stenosis at l5-s1.Patient underwent ir myelography two or more regions due to clinical history of back pain/ post laminectomy syndrome.Impression: lumbar and thoracic myelogram for ct imaging.On (b)(6) 2011 the patient underwent ct scan of the pelvis due to pain.Impression: post operative and degenerative changes without evidence of acute fracture.On (b)(6) 2011, patient underwent mammogram screening digital bilat.Impression: no evidence of malignancy.A one year screening mammogram is recommended.On (b)(6) 2012, patient underwent mri of lumbar spine w/wo contrast due to radiculopathy, postlaminectomy syndrome.Impression: no significant change compared to (b)(6) 2010.On (b)(6) 2013, patient underwent mammogram screening digital bilat.Impression: no evidence of malignancy in either breast roentgenographically.On (b)(6) 2013, patient underwent x-ray of chest two views.Impression: no active disease of chest.
 
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 Key5603944
MDR Text Key43492711
Report Number1030489-2016-01165
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 03/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510400
Device Lot NumberM115009AAI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/28/2016
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) Required Intervention;
Patient Weight64
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