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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 7510200 |
| 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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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.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.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 the patient was pre-operatively diagnosed with l4-s2 pseudo arthrosis with broken spinal instrumentation, intractable back pain and underwent the following procedures: l4-l5 and l5-s1 anterior lumbar interbody fusion.Placement of peek cage screw construct l4-l5 and l5-s1, allograft bone matrix, bone morphogenic protein.Neuromonitoring.Removal of instrumentation l4 through s1, revision spinal instrumentation l4 to the ilium, revision posterolateral fusion, l4 to ilium, local morcellized autograft, allograft bone matrix, bone morphogenic protein, neuromonitoring, intraoperative o-arm ct scan with computer navigation, connection of fusion to prior t10-l4 instrumentation.As per op-notes,¿ the set screws from l4 down to the ilium were removed.The broken rod was removed and then the remaining rods were cut up above the l4 level.The loose screws at l4 through s1 were removed.O-arm registration was placed in the iliac crest.O-arm was brought in for intraoperative ct scan.Computer registration materials verified.Under computer guidance, new screws were placed from l4 down to the ilium.O arm brought back in to verify good placement of instrumentation, rods were then cut and contoured to appropriate shape and length, placed over the new screws from l4 to the ilium bilaterally and connected to the previously placed rods from t10 down to the l3, connected with side-to-side connectors.Set screws were placed and final tightened.A high-speed decorticating burr was used to decorticate the remaining bony surfaces l3 down to the ilium.Irrigation performed.Homeostasis achieved.Remaining local morcellized autograft, allograft bone matrix, bone morphogenic protein were packed over the decorticated surfaces at l 3 down to the ilium.Subfascial drain placed.¿ the operative findings were: pseudo arthrosis, l4-l5 and l5-s1, with broken spinal instrumentation.No sustained neuromonitoring alerts.On (b)(6) 2017: the patient was discharged from the facility.
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Manufacturer Narrative
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Results of additional x-rays received: new imaging for this case were provided.At the lumbar-sacral junction, there is transitional "overlay".Depending on the numbering convention, there is a spondylolisthesis present at l4-l5 (or l5-s1).This deformity appears to be the site of the unilateral rod fracture although fractured on the side with the iliac screw, it is difficult to see the fracture of the rod at l4-l5 on the left side of provided images.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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X-ray review results: post-op/pre-revision x-rays provided for t10-iliac posterolateral fusion.By report, there was a l4-s2 pseudoarthrosis revised with interbody grafts at l4-5 and l5-s1.These interbody grafts are not present in the provided x-rays.In provided images, a rod fracture is not obvious.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) 2017: physical examination, spine: well-healed posterior incision.No signs of infection.Final pathological diagnosis: spine, bone and tissue sacral area: fibrocartilage consistent with intervertebral disc.Soft tissue with fibroid degeneration and neurotic bone fragments-no acute inflammation seen.(b)(6) 2018: the patient went for a for a follow-up visit.The assessment was c4-7 disk disease and stenosis with progressive signs of myelopathy, cervical radiculopathy, failed conservative treatment.Physical examination: spine: decreased cervical motion.Imaging: mri scan was reviewed.The patient doesn¿t have c4-7 disk disease and stenosis.(b)(6) 2018: reviewed problems: displacement of thoracic intervertebral disc without myelopathy - onset: (b)(6) 2017; degeneration of cervical intervertebral disc - onset: (b)(6) 2017; degeneration of thoracic intervertebral disc - onset: (b)(6) 2017 ; degeneration of lumbar intervertebral disc - onset: (b)(6) 2017 ;foot pain - onset: (b)(6) 2017, bilateral ;pes planus - onset: (b)(6) 2017, bilateral; hallux valgus - onset: (b)(6) 2017, bilateral; scoliosis deformity of spine - onset: (b)(6) 2017 ; closed fracture of fifth metatarsal bone- onset: (b)(6) 2017, left; cigarette smoker - onset: (b)(6) 2017 review of systems: patient reports muscle pain, muscle weakness, and back pain but reports no joint pain.She reports no insomnia, no fever, and no chills.She reports normal vision.She reports no chest pain.She reports no shortness of breath, no sleep apnea, and no copd.She reports no fecal incontinence.She reports no incontinence.She reports no rashes.She reports no numbness, no seizures, no headaches, and no tingling.She reports no depression and no anxiety.She reports no night sweats.Physical exam: range of motion cervical spine is improved, deep tendon reflexes are 2/4 bilateral lower extremities.
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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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Event Description
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It was reported that on: (b)(6) 2017: the patient went for a follow up visit.The assessment/plan is: severe ddd lumbar spine.Severe lumbar scoliosis.Hnp t-spine t3-t4 with cord contract.Severe ddd with collapse c4-c7.(b)(6) 2017: the patient was pre-operatively diagnosed with neuropathy, left ear hearing loss, osteoarthritis, irritable bowel syndrome, asthma, chronic obstructive pulmonary disease, fibromyalgia, gastroenteritis, anxiety and depression, degenerative scoliosis, noted last menstrual period approximately one week ago, cervical disc disease and stenosis.(b)(6) 2017: imaging: imaging studies revealed a pseudoarthrosis at the l4-s1 level with broken rod.(b)(6) 2018: the patient presented for a follow up visit.The examination results were: inspection palpation: palpation of cervical spine reveals tenderness.Muscle testing: motor strength testing of the muscles innervated by the cervical spine is graded at 5/5.Inspection palpation: palpation of lumbar spine reveals tenderness.Muscle testing: motor strength testing of the major muscles innervated by the lumbar spine is graded at 5/5 bilaterally.The assessments were: 6 weeks status post c4-c7 acdf - was doing well until a fall 2 1/2 weeks ago.Status post t10-ilium fusion and l4-s1 alif.The plans were: lumbar and cervical spine trigger point injection in the office today.Percocet 5/325 mg., 1 po twice daily, #40.Follow up in 4 weeks.(b)(6) 2018: the patient presented for a follow up visit.The physical examination results were: lumbar spine: muscle testing: motor strength testing of the major muscles innervated by the lumbar spine is graded at 5/5 bilaterally.(b)(6) 2018: the patient presented for a follow-up visit.The assessments were: no stenosis on ct scan.Mild proximal kyphosis.Status post t9-ilium fusion for scoliosis.No acute changes.The ct of thoracic spine w/o contrast dated (b)(6) 2018 at prime imaging coc was reviewed.The impressions were: 12 degrees left convex curvature of the mid and lower thoracic spine.No acute process or thoracic spinal stenosis and no hardware complication in the thoracic component of the scoliosis correction hardware which begins at t9 and extends to the sacrum.Mild right neural foraminal stenosis at t8-t9 from costovertebral junction hypertrophy.The plans were: no surgery recommended.L3-l4 lesi and follow up in 2 weeks.(b)(6) 2018: the patient went for follow up visit.The physical examination results were: musculoskeletal: lumbar spine: inspection palpation: tenderness with palpation of lumbar spine left psis, right psis.Rang of motion: lumbar spine range of motion is limited in flexion extension side-bending due to pain and stiffness.Muscle testing: motor strength testing of the major muscles innervated by the lumbar spine is graded at 4/5 in the left lower extremity.Motor strength testing of the major muscles innervated by the lumbar spine is graded at 4/5 in the right lower extremity.Special tests: sitting straight leg raise is positive bilaterally faber's sign is negative bilaterally heel walk: unable to bilaterally due to unsteady gait toe walk: unable to bilaterally due to unsteady gait clonus is absent.16 apr 2019: the patient underwent examination of spine.The impressions were: cervical or thoracolumbar spine changes.No acute thoracic spine abnormality.Lumbar spine: there are posterior metallic rods, fixed with pedicle screws at s1, l5, l3, l2, l1, t12, t11, t10 and t9.Screws project obliquely across both sacroiliac joints into the posterior iliac bones bilaterally, anterior screws are present, projecting obliquely through the inferior endplate of l3, superior and inferior endplates of l4 and lb.Opaque surgical material is present within the l3-j4 and l4-l5 disc spaces.There is posterolateral bone graft material.There is laminectomy, which appears to include l1-l5.There in uncinate osteophyte formation, particularly at l2-l3, l3-l4.The vertebral heights are normal.There is no evidence of fracture, spondylolisthesis, focal lytic or blastic areas.Thoracolumbar/sacroiliac surgical.Changes as reported above.Degenerative disc changes.No acute lumbar spine abnormality.
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Event Description
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It was reported report that on: (b)(6) 2019: the patient underwent examination for thoracic lumbar spine.The impressions were: thoracic spine x-ray: stable thoracic spine x-ray without evidence of acute abnormality status post lower thoracic posterior fusion.Posterior low thoracic fusion t10 through the thoracolumbar junction with poor visualization of the thecal sac from t10 inferiorly.Mild broad-based disc bulge at t4-t5 without compressive sequelae.No other evidence of thoracic spondylosis or acute traumatic injury to the thoracic spine.Lumbar spine x-ray: extensive post-surgical change from the lumbosacral fusion with interval development of a transverse oriented nondisplaced fracture through the vertically oriented right-sided fusion rod at the l5 level.No evidence of acute complication of the transpedicular screws.Nondisplaced subtle appearing fracture in the left-sided vertically oriented lumbar rod also at the l5 level, best seen on coned down compression view, likely not significantly changed since (b)(6) 2019.No evidence of acute change in alignment to the lumbar spine or acute abnormality of the lumbar spine.Extensive susceptibility artifact in the field-of- view from the posterior lumbosacral fusion.There is decompression of the lumbar spine from l2 through l5 with laminectomies and a posterior midline fluid collection measuring 5.5 x 3.3 x 9.5 cm.No internal complexity to this to suggest abscess.This is most likely postoperative and seromatous.Poor visualization of the upper lumbar thecal sac due to the artifact.If there remains clinical concern for abnormality to the surgical hardware itself, follow-up x-rays might be considered.If there is clinical concern for compressive sequelae in the thoracolumbar region or involving the neural foramina, follow-up ct myelogram be considered.(b)(6) 2019: the patient underwent examination lumbar spine.The impressions were: fluoroscopic images demonstrate posterior spinal fusion hardware in place extending from the lower thoracic spine down to the iliac level bilaterally.There appears to be fracture of the spinal rods bilaterally at l4 as above.Successful intrathecal administration of 15 ml of isovue-m 200 via lumbar puncture at l3-4 as above.No obvious high-grade spinal canal narrowing is appreciated on preliminary fluoroscopic images.The patient underwent examination lumbar spine w/contrast.The impressions were: there appears to be lumbarization of the l5 vertebral body.For the purposes of this examination, the first nonrib-bearing vertebral body is labeled as l1 as above.Posterior fusion hardware in place extending from the lower thoracic spine to the upper sacrum with pedicle screws and posterior fusion rods in place.The lowest screws extend into the right and left ilium as above.There have been posterior laminectomies from l1 through l5 and interbody fusions from l3-4 through l4-5.The posterior fusion rods appear to be fractured bilaterally at the l4 level where no pedicle screws are present.This is best appreciated on fluoroscopic images during the contrast injection.No significant spinal canal stenosis appreciated within the lumbar spine or visualized lower thoracic spine.There is minimal bilateral neural foraminal narrowing at l3-4 and minimal left neural foraminal narrowing at l4-5 as above.Stable posterior paraspinal collection extending between and posterior to the fusion rods extending from l1 through l5.Again, this is likely to represent a seroma.Mild s-shaped thoracolumbar scoliosis.(b)(6) 2019: the patient underwent examination for back pain.The impressions were: x-rays do show a broken rod at l4-5 on the right side.Left side appears intact.There is a pseudoarthrosis at the l4-5 level.Ct myelogram did not show any significant neurologic compression.
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Manufacturer Narrative
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Additional information: correction: the aware date of regulatory rep #:1030489-2018-01450 was entered wrong.The correct aware date was (b)(4) 2019.Due to this the due date was incorrectly set as (b)(4) 2018 which should have been (b)(4) 2019.If information is provided in the future, a supplemental report will be issued.
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