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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510600 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Inflammation (1932); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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It was reported that on: (b)(6) 2007, the patient presented with pre-op diagnosis of :severe degenerative disk disease , multiple level lumbar spine.Spinal stenosis , lumbar spine.Neurogenic claudication.Lumbar radiculopathy.Severe structural back pain.The patient underwent following procedures: trans-abdominal extra peritoneal exposure of the spine.Mobilization of major vessels.Anterior discectomy at l2-3 , l3-4 , l4-5 , l5-s1.Anterior lumbar interbody distraction of the collapsed disc spaces at the l4-5 and l5-s1 using sequential wedge distractors.Anterior lumbar interbody fusion utilizing peek spacer supplemented by rhbmp-2 and graft matrix at l2-3 , l3-4 , l4-5 , l5-s1 levels.Buttress screw and washers at the l2-3 , l3-4 , l4-5 , l5-s1 levels.Other procedure performed were: total laminectomy at l3, l4, l5.Partial laminectomy at l2, s1.Intrathecal morphine instillation.Pedicle screw insertion at l2-s1 bilaterally for fixation of hypolordosis right and left side made by laguna allez spine.Rod insertion l2-s1 for correction and stabilization of spinal deformity.Per op-notes, ".The spacers were cleaned out of all disc material and gradually distracted.Following that , they were grafted with bmp soaked sponges and peek spacers filled with similar material.This was done at l2-3 and l3-4 levels." following the surgery, the patient suffered significant pain in the area of the fusion surgery and extremities.The patient underwent additional imaging that showed that the patient had developed bony overgrowth and inflammation.The patient has received significant medical treatment to care for the injuries caused by the original fusion surgeries.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: radiographic image review- post-op x-rays for thoraco pelvic fixation show a rod fracture bilaterally at the lumbar thoracic transition.The provided patient history dates to 2007/8 and multiple procedures are described.Patient saggital balance is difficult to assess and fusion status is unknown.Fracture level noted to be l1-2 or l2-3 at different points in the event summary.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: radiological image review results: ct scan of l spine (b)(6) 2015- l2-s1 solid bony fusion ct scan of t/l spine (b)(6) 2015- l5-t10 fracture of right l3 "connection or disconnection" only ct reviewed for this patient.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on: (b)(6)2008 : patient underwent x-ray of neck which revealed excellent alignment.(b)(6)2010 : patient presented for office visit.Assessment: cervical and lumbar stenosis.(b)(6)2012 : patient underwent x-rays in 5 views of cervical spine which reveal loss of lordosis, degenerative changes at c3-4.C5-6 fused nicely.Patient also underwent 5 view of lumber spine which reveal fusion from l1 to sacrum.There¿re degenerative changes at t12-l1 and t11-12.Assessment: status post cervical fusion with residual neck pain, stable.Status post l1-s1 fusion and pain directly over his right sacroiliac joint with tenderness and probable sacroiliac joint pain.(b)(6)2012: patient underwent x-ray of cervical spine which revealed good alignment and position of internal fixation.No hardware failure.X-rays of low back revealed l5-s1 fusion with degenerative changes above.Assessment: lumbar degenerative joint disease, stable, post multiple fusions.Cervical degenerative joint disease, stable.(b)(6)2014: patient underwent 5 view of cervical spine which revealed no evidence of hardware fracture.Patient also underwent 2 view of lumbar spine which revealed no fracture no compression fracture above or failure of hardware.Assessment: cervical and lumbar sprain superimposed onpre-existing multilevel degenerative disc disease and fusion.(b)(6)2014: patent presented with bilateral back pain.(b)(6)2014: patient presented for office visit.Assessment: patient has tenderness over right sacroiliac joint.(b)(6)2014: patient underwent mri of cervical spine.Impression: severely degraded exam due to anterior fixation hardware.Moderate to severe spinal stenosis at c3-4 is producing cord compression and cord edema.Moderate spinal stenosis c7-t1 is resulting in cord edema.(b)(6)2014: patient underwent mri scan of cervical spine which revealed moderate stenosis at c3-4 but severe stenosis at c7-t1 below c4-7 fusion.Assessment: this gentleman has no lower extremity complaints and no myelopathy but he does have severe weakness of left c8 nerve root.At this point his pain is gone.(b)(6)2014: patient presented for office visit.He has weakness of his c8 nerve root in his left hand but his neck has loosened up.(b)(6)2014: patient comes in for evaluation.Patient has significant weakness of his left c8 nerve root.Assessment: previous l2-s1 fusion.Patient underwent mri scan of lower back which revealed slight stenosis above fusion.There¿re no compression fractures and no severe stenosis.30 jul 2014: patient underwent mri scan of cervical spine which revealed moderate stenosis at c3-4 but severe stenosis at c7-t1 below c4-7 fusion.(b)(6)2015: patient underwent mri cervical spine without contrast.Impression: limited cervical spine mri due to extensive susceptibility artifacts associated with surgical hardware.Surgical decompression and internal fixation demonstrated from c1-t1 with no evidence of acute fracture.(b)(6)2015: patient underwent ct thoracic spine.Impression: no evidence of fracture or migration of hardware.Mild degenerative di scogenic disease and endplates irregularity at t9-10 through l1-2.
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Manufacturer Narrative
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Additional information: event, relevant tests/laboratory data, other relevant history medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
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Event Description
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It was reported that: on (b)(6) 2007: patient underwent ap and lateral views of lumbosacral spine.Conclusion:limited portable study without evidence of significant change.On (b)(6) 2007: patient underwent ap and lateral views of lumbosacral spine.Conclusion: stable exam status post fusion.On (b)(6) 2007: patient underwent two view lumbar spine.Conclusion: stable appearance of lumbar spine status post laminectomy and fusion of l2 through s1.On (b)(6) 2007: patient underwent radiograph lumbar spine.Conclusion: postsurgical changes of lumbar spine.Minimal retrolisthesis of l2 vertebral body with respect to l3 which decreases somewhat with flexion.On (b)(6) 2007: patient underwent lumbar spine films.Conclusion: status post fusion l2 through s1.Fixed retrolisthesis of l2 on l3 is seen.On (b)(6) 2007: patient underwent x-ray of cervical spine with flexion and extension.Conclusion: no acute abnormalities.On (b)(6) 2007: patient underwent ct cervical spine without contrast.Conclusion: fracture of inferior left screw at c6, otherwise intact appearance of cervical spine.No evidence of non-union.Patient underwent ct lumbar spine.Conclusion: post-surgical changes in lumbar spine with bone in stable, near anatomic alignment.No evidence of hardware failure.On (b)(6) 2007: patient underwent x-ray cervical spine.Conclusion: status post-surgery from c4-7.Degenerative narrowing at c6-7 with right sided osteophytes and right c6-7 foraminal stenosis.On (b)(6) 2008: patient underwent x-ray cervical spine.Conclusion: persistent degenerative narrowing at c6-7.There appears to be further fusion at fusion mass level of c5-6.On (b)(6) 2008: patient underwent chest pa and lateral views.Conclusion: status post prior cervical spine surgery.Otherwise negative.
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Manufacturer Narrative
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Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
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