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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 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
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 eve.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 through patient's medical records that: (b)(6) 2010: patient presented with chief complaint of scoliosis.X-rays of spine and long cassette ap and lateral reveal a main thoracic curve of approximately 59 degrees.Assessment: idiopathic scoliosis (b)(6) 2010: the patient underwent mri lumbar spine without contrast because of scoliosis.Impressions: mild multilevel degenerative disc disease as described.Question small annular tear l4-5.No focal disc herniation scoliosis.The patient underwent mri cervical spine without contrast.Impression: at c4-5 there is a small focal bulge in the posterior contour of the disc far laterally to the left.At c5-6 degenerative disc disease is noted with bulging of the disc posteriorly in the midline into the left, probably a degree of disc herniation, and with mild flattening of the ventral contour of the cord.On (b)(6) 2010: patient presented for follow-up of her mri of her cervical and lumbar spine.Follow-up result: her cervical spine shows mid cervical kyphosis with disc herniation at c5-6 that touches the ventral portion of the spinal cord but does not indent it nor does it cause any myelomalacia.She has no neuroforaminal stenosis at any level.Mri of the lumbar spine reveals at l3-4 on the right side she has facet hypertrophy and very slight disc bulging that result in right-sided greater than left-sided neuroforaminal stenosis and very slight lateral recess stenosis.L4-5 shows disc desiccation on the sagittal images with ever so slight broad-based disc bulging, no significant foraminal stenosis at that level.The l5, s1 disc appears to be well hydrated and without any degenerative changes.The facet joints at l5, s1 are also intact and without degenerative change.On (b)(6) 2010: the patient underwent chest pa and lateral.Impressions: severe scoliosis.Otherwise unremarkable exam.On (b)(6) 2010: patient presented for follow-up for preoperative discussion prior to undergoing posterior spinal fusion for scoliosis.Follow-up result: her physical examination reveals that her left shoulder clinically is a little low, her pelvis is level, skin is without lesions.Her x-ray shows her standing main thoracic curve to be 65 degrees and her lumbar curve to be about 39 degrees.When she bends to the right, her lumbar curve goes down to 11 degrees.When she lies supine, her main thoracic curve goes to 55 degrees and bending to the left, allows her curve to go down to 49 degrees.No other significant findings are noted on her x-rays.On (b)(6) 2010: the patient was presented with the following pre-op diagnosis: adult idiopathic scoliosis, progressive.She underwent the following procedures: posterior spinal fusion t2-l5.Posterior segmental spinal instrumentation t2-l5.Posterior osteotomies ti2-t2 (inferior facetectomies).Autograph bone grafting.Allograft bone grafting.Posterior iliac crest bone grafting.Application of gardner-wells tongs.Intraoperative cranial traction.Bone morphogenic protein use.Examination spine thoracolumbar ap <(>&<)> lat was performed because of scoliosis.Impression: bilateral harrington rods placed.As per op-notes ,¿ we then performed multilevel osteotomies in the thoracic spine to increase the flexibility of the spine, expose bony landmarks for screw placement allow for decortication and removal of cartilage from the facet joints as well as obtain autograph bone.Then, utilizing anatomic landmarks, we placed pedicle screws from l5-t2 in a sequential fashion starting on the left followed by the right.All screws were then confirmed radiographically as well as with pedicle stimulation and felt to be in acceptable position.We then measured, cut and contoured rods and reduced the spine to the rods.Following this we aspirated bone marrow from the patient's left iliac crest and placed that over a hydroxyapatite and infused sponge to act as a bone graft extender.In addition, we used multiple large kits of bone morphogenic protein as well as autographed and allographed bone.We decorticated the posterior bony elements as well as pulse lavage with copious amounts of antibiotic laden sterile saline.The overall correction was confused radiogra phically.We placed a bone graft over the decorticated posterior bony elements followed by placement of deep drain.The wound was closed in layers ¿.No intra-operative complications were reported.On (b)(6) 2010: the patient was presented with adult idiopathic scoliosis because of scoliosis.Impression: status post thoracolumbar fusion.No active disease.On (b)(6) 2010: patient presented for follow-up of her t2 to l5 posterior spinal fusion for progressive adult idiopathic scoliosis.Follow-up result: she is doing quite well.She has some right-sided low back pain at the lumbosacral junction but otherwise really is feeling quite well.Her pain is mostly at the end of the day.She feels like she is still pitching forward a little bit and a little bit off to the right.Physical examination reveals that her wound is well heated.Her tattoo lined up nicely.No evidence of infection.She does stand with both knees bent and slightly pitched forward however she corrects this when she is conscious of it.She can stand perfectly straight with no forward-pitched posture.Her x-rays reveal that she does stand in positive sagittal imbalance and coronal imbalance to the right.Her curve measurements are 7/20/30 from preoperative curve measurements of about 30/70/50.Overall all implant placements are in good position.No evidence of failure of instrumentation.On (b)(6) 2010: patient presented for follow-up of her t2 to l5 posterior spinal fusion for progressive idiopathic scoliosis.Follow-up result: she is slowly getting better.Her pain is at 4-5/10 and is primarily located in the interscapular region.She still feels like she is pitching slightly forward but her friends told that her right shoulder seems to droop.Overall her wound is well healed.She does stand with a bit of a knee flexion, hip flexion.I examined her hips and i was not able to get them to neutral or any beyond neutral for that matter.Her knees are without any evidence of flexion contractures.X-rays today show improvement of her overall coronal balance as well as sagittal balance and no evidence of failure of instrumentation.No other significant findings are noted.On (b)(6) 2010: patient presented for follow-up of her posterior spinal fusion from t2 to l5.Follow-up result: her physical examination today reveals no evidence of infection.Her wound is well healed.She does still have a little bit of a flexed knee gait likely compensating for her sagittal balance and coronal imbalance.Her x-rays today show that she is now in negative sagittal imbalance which is a dramatic improvement from several months ago.She does still tip off to the right side a little bit and does have a bit of a right-sided limb length discrepancy.On (b)(6) 2010: patient underwent ct t-spine without contrast because of scoliosis.Impression: idiopathic thoracolumbar rotatory scoliosis.Prior pedicle screw and rod fusion from t2-l5.On (b)(6) 2010: patient presented for follow-up of her adult deformity surgery and preoperative discussion prior to undergoing an l3 pedicle subtraction osteotomy, removal of instrumentation, exploration and fusion and caudal extension of her fusion to l5, s1 with iliac instrumentation and anterior lumbar interbody fusion at l5, s1 via tlif approach.On (b)(6) 2010: the patient was presented with the following pre-op diagnosis: adult idiopathic scoliosis.Lumbar degenerative disc disease.Coronal imbalance syndrome.Sagittal imbalance syndrome.She underwent the following procedures: removal of instrumentation l2-l5.Revision instrumentation l2-l5.Bilateral posterior smith-petersen osteotomies l5-s1.Bilateral posterior smith-petersen osteotomies l3-l4.Bilateral posterior smith-petersen osteotomies l2-l3.Exploration affusion l 1-l5.Instrumentation s1.Iliac instrumentation.Posterior spinal fusion l2-s1.Transforaminal lumbar interbody fusion, l5-s1.Placement of anterior interbody spacer l5-s1.Autograft bone grafting.Allograft bone grafting.Bone morphogenic protein use.Application of gardner-wells tongs.Intraoperative cranial traction.As per op notes,¿ dissection was carried out down to the level of the bilateral iliac and cranially up to t12.We exposed all implants and dissected out to the tips of the transverse processes at each level.It appeared that an attempt at fusion was being made at every level.The l4-l5 level appeared to be the most solidly fused.Intervening levels had varying degrees of attempts at fusion.T12-l 1 and l 1-l2 appeared to be well on the way to fusion.We then placed the iliac screws bilaterally and removed the screws from l2-l5 and replaced them upsizing them 1 diameter at every level except l3 where the screws were left out.We then performed bilateral inferior facetectomies and superior facetectomies l5-s1 followed by a complete foraminotomy on the patient's left side at l5-s1 in preparation for the transforaminal lumbar interbody fusion.We then placed s1 screws and confined the position of all screws radiographically followed by stimulation with pedicle via the nerve monitoring tech.We then began preparation for the pedicle subtraction procedure and with a high-speed drill, cut through the fusion mass at l2-l3 and l3-l4, all the way down to bilateral foramina.Once this was completed, we noted a significant amount of correction of her deformity and a decision was made at this point not to perform the pedicle subtraction procedure, but to stop with generous smith-petersen osteotomies at both levels.We then cut her old rods and measured, cut and contoured new rods, linked them up to the old rods with dominos, removed the left-sided screw to facilitate the dominos placement and placed dominos above and below the l2 screw on the right side.We then decorticated all posterior bony elements and placed 2-1/21arge kits of bone morphogenic protein with 1-1/2 of large kit being placed in the anterior interbody spacer at l5-s1 along with allograft bone.After complete discectomy and placement of a 13 mm medtronic boomerang peek cage to complete the transforaminal lumbar interbody fusion, the rods were measured, cut and contoured and reduced into the screws and all posterior bony elements were decorticated.The autograft bone and bmp were placed over the exposed bony elements as well as in the gutters bilaterally.A crosslink was placed at l2-l3 and a deep drain was placed.The wound was closed in layers, taking care to reapproximate her caudal tattoo.On (b)(6) 2011: patient presented for follow-up of her revision posterior spinal fusion extension to her pelvis.F/u results: she is doing much better now at the six week point than she was doing at the six month point after her first surgery.On (b)(6) 2011: patient presented for follow-up of her revision scoliosis surgery and extension to her pelvis.F/u results: her back pain is slowly abating.Her left knee is still bothering her.She got about one day of relief from her knee injection.An mri was ordered and according to janet the report was normal.On examination her wound has healed well her clinical balance appears to be perfect.Her knee still reveals significant tenderness to palpation around the anterior medial and lateral joint line.She does have what appears robe a bit of an effusion, but her strength is normal.She has a little bit of an extensor lag.She has no tenderness to palpation along the patellar ligament or quad tendon.No pain with attempted subluxation of the patella.On (b)(6) 2011: patient presented for follow-up of her revision posterior spinal fusion, extension to the pelvis and multilevel osteotomies.F/u results: she is doing reasonably well.She has pain over the left side of her low back she has not been wearing her heel lift at all.Her x-rays show no failure of instrumentation.She docs still have a right-sided limb length discrepancy that is about 1centimeter in height.On (b)(6) 2014: the patient was presented with the following pre-op diagnosis: sporadic lower back pain, more right sided.Radiographs results: long cassette standing ap and lateral scoliosis films reveal that all of her screws are intact, but her rods have fractured just above the s1 screws bilaterally.No other failure of instrumentation.She has lost some of her lumbar lordosis.Assessment: adult scoliosis: failure of instrumentation.Idiopathic scoliosis.On (b)(6) 2015: patient presented with the following chief complaint: f/u for lumbar scoliosis.The patient was presented with the following pre-op diagnosis: sharp pain.Her pain at rest is 7/10, achy, constant.Aggravated with activity, alleviated with rest.Radiographs results: long cassette standing ap and lateral scoliosis films reveal a failure of the rods at l5, s1 with no other obvious failure of instrumentation.Her sagittal and coronal planes are unchanged from prior to her failure of instrumentation.On (b)(6) 2015: patient presented with the following chief complaint: pre-op lumbar, instrumentation failure repair- removal of instrum entation of l1 with fourth rod construct across lumbosacral junction with replacement of screws.Dos: (b)(6) 2015).Radiograph results: radiographs reveal no new failure of instrumentation.No other obvious changes from her prior set of x-rays.The patient underwent xr chest 2v.Impression: scoliosis with harrington rod placement, lungs are clear.(b)(6) 2015: the patient was presented with the following pre-op diagnosis: adult scoliosis.Failure of instrumentation.She u nderwent the following procedures: removal of instrumentation.Exploration of fusion.Revision posterior spinal fusion l5-s1.Revision instrumentation t12-s1.Revision bilateral iliac instrumentation.Autograft bone grafting.As per op notes, ¿she was sterilely prepped and draped in the standard fashion.Her surgical scar was resected in total and dissection carried out down to the posterior elements.We exposed her prior instrumentation and fusion mass from t12 down to s1.We found what appeared to be a solid fusion throughout with both rods broken, the left rod within the l5 screw, the right rod between the l5 and the s1 screw.There appeared to be solid fusion mass the length of her lumbar spine.We removed the instrumentation from the dominoes roughly at l1 down to bilateral iliac bolts.We further explored the fusion and found no evidence for obvious pseudarthrosis suggesting that the rod failure was due to mechanics rather than a pseudarthrosis.We replaced the screws from l3 to s1 and bilateral ilia to leave the room for dominoes to both connect to the thoracic rods as well as placed two additional rods across the lumbosacral junction to hopefully prevent future rod failures.We measured, cut and contoured rods and reduced the spine to the rods followed by placement of 2 ad ditional rods for 4-bar construct from l3 to bilateral iliac bolts.Final intraoperative ap and lateral radiographs were obtained showing acceptable placement of all implants and overall position of the spine.Spine.The wound was then irrigated with copious amounts of antibiotic-laden sterile saline through a pulse lavage.The residual posterior bony elements were decorticated.Autograft bone and vancomycin powder were packed at the l5-sl junction where the fusion mass was decorticated to hopefully provide further fusion mass and additional strength at the junction.A deep drain was placed.The wound was closed in layers.The patient awoke without event and was taken to the recovery room in stable condition.¿no intra-operative complications were reported.On (b)(6) 2015: patient presented with chief complaint: status post revision posterior fusion l5-s1, instrumentation revision t12-s1, rev.Bilat iliac instrumentation dos: (b)(6) 2015.Radiograph result: ap and lateral long cassette radiographs were taken today showing no failure of her instrumentation.Assessment: status post revision lumbar fusion with wound stitch abscess (b)(6) 2016: patient presented with chief complaint: follow-up s/p revision posterior fusion l5-s1, instrumentation revision t12-s1, rev.Bilat iliac instrumentation dos: (b)(6) 2015, 42 days out.The patient was presented with the following pre-op diagnosis: other idiopathic scoliosis, site unspecified.(b)(6) 2016: patient presented with chief complaint: follow-up s/p revision posterior fusion l5-s1, instrumentation revision t12-s1 (dos: (b)(6) 2015).Assessment: idiopathic scoliosis (b)(6) 2016: patient presented with chief complaint: follow-up lumbar, s/p revision posterior fusion l5-s1, instrumentation revision t12-s1 (dos: (b)(6) 2015)- 2 months 1.5 weeks out, doing well, here for a wound check, pain 4/10 today.(b)(6) 2017: the patient was presented with chief complaint: follow-up revision at l5 s1 and instrumentation revision at t12-s1(dos: (b)(6) 2015).Pre-op diagnosis: idiopathic scoliosis, back pain, bilateral lower extremity symptoms, upper thoracis pain and lumbosacral junction pain since the time of injury.Radiograph results: long cassette standing ap and lateral scoliosis films reveal no failure of instrumentation.No adjacent level changes.
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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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Event Description
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It was reported per patient's medical records that on: (b)(6) 2011: patient presented for follow-up of her knee pain/left and osteoarthritis (follow-up visit), which began 1 month ago.Follows ortho, tx with coil injection, had x-rays & mri.(b)(6) 2013: patient presented for osteoarthritis, scoliosis and idiopathic (followup visit), which is chronic.Wax & wanes with overuse.(b)(6) 2014: the patient presented with the following pre-op diagnosis: low back pain, chronic.Range of motion: limited range of motion secondary to pain.The character of the pain is described as dull.The location of the pain: lower back.Exacerbating factors include bending, walking.Relieving factors include rest.Previous back problems known djd (degenerative joint disease).H/o scoliosis follows ortho spine.(b)(6) 2014: the patient presented for follow-up visit regarding knee pain/left, osteoarthritis, scoliosis and idiopathic which is chronic.S/p hyalgan with no sign of improvement.
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Manufacturer Narrative
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X-rays review: post-op x-rays for thoraco-lumbar fixation were provided.Date of imaging is (b)(6) 2015.By report, this is the date of one of the revision surgeries.By the description the initial rod fracture was identified in (b)(6) 2014 at l5/s1.These appear to be post revision films as there is the described 4-bar construct without evidence of rod fracture at l5-s1.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: x-ray review results: multiple x-rays and ct were provided for correction of adult idiopathic scoliosis.Initial x-rays show progression of scoliosis with first surgery 2010 at t2-l5.Post-op x-rays with adequate deformity correction and acceptable hardware placement.Revision surgery of (b)(6) 2010 - unclear why revision occurred and hardware failure could not be seen on provided images.Post-op x-rays (b)(6) 2014 show bilateral rod fractures at s1.Revision surgery 2015 with repeat of solid fusion throughout.An inter-body graft is present at l5-s1.Other imaging suggests the construct remains stable.Unclear reason for rod failure at l5 junction in setting of complete fusion by report.Provided ct (b)(6) 2019 shows bone fusion at l5-s1.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) 2015: patient presented with the following pre-op diagnosis: 1.Failure of scoliosis surgery in the past with removal of instrumentation and revision of spinal fusion l5-s1.2.Acute blood loss anemia.3.Rheumatoid arthritis.4.Anxiety.5.Chronic back pain.6.Hypothyroidism.The patient underwent the following procedure: the patient has had removal of instrumentation, exploration and fusion, revision of posterior spinal fusion l5-s1, revision of instrumentation t12-s1, revision of bilateral iliac instrumentation and autograft bone grafting.As per operative notes, ¿we exposed her prior instrumentation and fusion mass from t12 down to s1.We found what appeared to be a solid fusion throughout with both rods broken, the left rod within the l5 screw, the right rod between the l5 and the s 1 screw.There appeared to be solid fusion mass the length of her lumbar spine.We removed the instrumentation from the dominoes roughly at l 1 down to bilateral iliac bolts.We further explored the fusion and found no evidence for obvious pseudoarthrosis suggesting that the rod failure was due to mechanics rather than a pseudoarthrosis.We replaced the screws from l3 to s 1 and bilateral ilia to leave the room for dominoes to both connect to the thoracic rods as well as placed two additional rods across the lumbosacral junction to hopefully prevent future rod failures.We measured, cut and contoured rods and reduced the spine to the rods followed by placement of 2 additional rods for 4-bar construct from l3 to bilateral iliac bolts.Final intraoperative ap and lateral radiographs were obtained showing acceptable placement of all implants and overall position of the spine.The wound was then irrigated with copious amounts of antibiotic-laden sterile saline through a pulse lavage.The residual posterior bony elements were decorticated.Autograft bone and vancomycin powder were packed at the l5-s1 junction where the fusion mass was decorticated in order to hopefully provide further fusion mass and additional strength at the junction.¿patient presented with the following post-op diagnosis: 1.Revision of instrumentation t12-s1, revision posterior spinal fusion at l5-s1, revision of bilateral iliac instrumentation.2.History of scoliosis.Patient presented with xr spine thoracolumbar 2v.Impressions: postsurgical changes from harrington rod placement for known scoliosis without gross complication.07 feb 2019: the patient was presented with the following pre-op diagnosis: 1.Adult scoliosis.2.Failure of instrumentation.3.Th oracolumbar pseudoarthrosis.The patient underwent following procedures: 1.Removal of instrumentation t11 to l2.2.Exploration of fusion, t12-l2.3.Revision posterior spinal fusion, t12-l 1, l 1-l2.4.Revision instrumentation, t11-l2.5.Escharotomy.6.Application of incisional wound vac (prevena).As per operative notes, ¿she was sterilely prepped and draped in the standard fashion.Her surgical scar was resected to get fresh bleeding margins and dissection carried out down to the prior crosslink.We then exposed over each rod from the midline crosslink and exposed cranially up to the t10 screw and caudally down to the l2 screw.We noted the broken rod below the left t12 screw.The rod on the right side appeared to be intact at all levels.We then explored the fusion.After removal of the crosslink and found that the fusion appeared to be solid, but then over the areas explored from roughly t12 down to l2, i did not find any distinct cleavage through any level.We then removed the set screws in dominos on the left side followed by removal of the left t12 screw.We then connected the thoracic rod to the lumbar rod via a short rod and dominos above and below.We performed an intraoperative confirmatory ap and lateral radiographs showing acceptable placement of those implants.We then irrigated the wound with copious amounts of antibiotic-laden sterile saline, decorticated the residual posterior bony elements and packed a utograft bone obtained from the fusion mass above and below over the levels t12-l 1 and l 1-l2.¿ the patient underwent removal of instrumentation, exploration of fusion, revision of instrumentation and fusion of thoracic and lumbar spine with autograft, allograft.(b)(6) 2019: the patient felt a pop in her back in which outpatient imaging revealed left-sided broken rod of the thoracolumbar junction.She underwent following procedure removal of instrumentation t11 to l2, exploration of fusion, t12-l2, revision posterior spinal fusion, t12-l 1, l 1-l2, revision instrumentation, t11-l2.Patient underwent left t12 screw removal, thoracolumbar rod replacement (xr spine thoracolumbar 2v).Impressions: examination of the thoracolumbar spine demonstrates extensive rod and screw fixation.There is poor delineation of the l5 vertebral body on lateral projection.There is persistent s-shaped scoliosis of the spine with suggestion of multilevel spondylotic autofusion.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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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