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Clinical export data and log files were received and thoroughly inspected.Post operative ct scans were received and compared to the pre-operative planning that was prepared for the case.Deviations were noted at the t10 - t12 and l1 right levels.The deviation nature was consistent with the left trajectory appearing medial to the original plan and the right trajectory appearing laterally placed to the original plan.Upon review of the operation flow, the attempt at instrumenting the t10 to l1 region started at l1 left and continued up to t10 left, then down the right side.The t10-l1 segment was performed after the l2-s2 segment.The l2-s2 segment was deemed accurate intra-operatively and was confirmed to be accurate in post-operative scans.After reviewing all available information, no indication of malfunction of the system during the surgery was found.If information is provided in the future, a supplemental report will be issued.
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Section d3 was updated.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.
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Medtronic received information from the patient regarding a guidance system being used during a spinal procedure to treat multilevel non-unions in the lumbar spine.The surgery occurred on (b)(6) 2017.After the procedure to place the screws, the hcp stated that intra and post-operative scans looked good.The patient reported that a couple weeks after surgery, they were taken to the emergency room due to trouble catching their breath, trouble swallowing, they could not sleep, and other problems.The patient had a 95.5-degree temperature and felt they were going into shock.While at the emergency room, a ct scan was done of the patient¿s chest and the screws were found to be misplaced.The patient later reported that they had 18 screws placed in their spine, but their hcp had decided to remove them.Removing the screws left them with no fusion at multiple levels and they had pain and injury from the misalignments and non-unions that was excruciating and disabling.The patient further stated that two of the screws were placed in their spinal canal and that caused horrible pain reaching around their chest, and multiple other screws were ¿badly¿ misaligned.The patient also stated a nerve injury caused bladder and flaccid bowel incontinence and other issues exasperated with rolling out of bed, walking and standing.The patient¿s family health care professional (hcp) felt the neurogenic bladder was nerve related and prescribed oxybunitin, with moderate relief.Medical records indicated that during the on (b)(6) 2017 surgery, an area of a previous attempted fusion (l2-l5) was inspected and no fusion was found on visual and mechanical inspection.Decompression was performed at l5-s1 with a partial laminectomy, facetectomy and neuroforaminotomy.Stenosis was found and extensive ligament flavum hypertrophy was removed.A partial facetectomy and neuroforaminotomy with partial laminectomy at l5-s1 was performed.Pedicle screws were placed into the vertebral bodies t10 to s2/iliac wing.Rods were passed into the tulips of t10 through s1 pedicle screws bilaterally and bilateral s2/iliac pelvic fixation.Screw caps were attached and torqued.The hcp noted that x-rays confirmed excellent position of the interbody spacer and pedicle screws.There were no complications.According to the medical records, a ct scan of the patient¿s chest was done on (b)(6) 2017 and showed posterior spinal fusion was evident and the left pedicle screw at t11 appeared to enter the central canal and cross the left lateral recess.A ct scan of the thoracic spine was done on (b)(6) 2017.The scan found the hardware to be intact.At an office visit on (b)(6) 2017, the patient stated their hcp told them that some of the screws had an in-out-in¿ approach and there was a small breach of the spinal canal at t11, but that was not causing any clinical symptoms.The patient further stated that walking had become ¿all but impossible.¿ additional information from the patient was received reporting that after the fusion surgery, they had undergone additional scans and procedures including ct scans, mri scan, x-ray scans, pet scan, gastrologist consult for swollen lymph nodes following the abdomen approach to spine alif/plif 360 degree surgery, drainage of a reoccurring large fluid mass on arch of spine, corticoid injections around screw heads as the spine dynamics are pushing outward causing pain and one screw to be outside the vertebral body.Ap and lateral scans of the lumbar spine from on (b)(6) 2017 showed no change in position of screws and no evidence of any hardware fracture.A ct scan of the lumbar spine was completed on (b)(6) 2017.The scan was compared to a prior ct scan on (b)(6) 2017.The patient had back pain with radicular symptoms and hyperesthesia in the low back area.The scan showed the patient had excellent fusion at l2-l3, l3-l4, l4-l5 and l5-s1, but not above l2.The records further showed a breach of the screw on the right side at t10, and there may have been minor breach of t11 and t12.Screws at t12-l2 were noted to be entering the lateral aspect of the corresponding vertebral body.The hcp recommended hardware removal.On (b)(6) 2017, surgery was conducted to remove hardware from t10-s1 and iliac screws, inspect the fusion of t10-s2, and refuse areas of nonunion if noted.Apparent loosening of the si screws on lumbar and thoracic films were unchanged in alignment of the pedicle screw instrumentation.Visual and mechanical inspection revealed a good fusion at t10 to sacrum.There were no complications noted in the medical records.After the removal of the screws, the patient had a series of mri, x-ray and ct scans completed on (b)(6) 2018.In addition to imaging, the patient visited their hcp on (b)(6) and on (b)(6) 2018.The patient reported they followed up with a different hcp on (b)(6) 2018 who recommended a 12-level fusion with multiple levels of osteotomies as a revision to the prior procedures.The hcp also noted that the majority of his back pain appears to be axial and mechanical in nature, likely related to no significant fusion development following his prior procedures.A t 10¿ilium fusion was previously performed which did help with his back pain, but due to misplaced hardware it appears his surgeon removed his hardware at five months postop.Medical records from on (b)(6) 2018 report that the patient underwent a posterior osteotomy of l5-s1, anterior osteotomy of l4-s1, anterior lumbar interbody fusion of l5-s1, anterior plating of l5-s1 and insertion of machine biologic spacer at l5-s1.The operation notes indicate the patient had coronal plane deformity secondary to inappropriate reconstruction of the lumbar disk space especially at l4-l5 resulting in lateral listhesis at l3-l4 and l2-l3, and pseudarthrosis l5-s.The operation notes indicated the procedure was completed without complication.Medical records from on (b)(6) 2018 indicate the patient underwent a procedure to fuse l3 through s1 as part of a planned staged operation.Pedicle screws were placed at l4 and l5, but not placed at l3 as a result of fusion anteriorly.Iliac wing screws were then placed along with the rods and screw caps.The medical records indicate the procedure was completed with no complications.The patient made multiple visits to their hcp between on (b)(6) 2019 due to abdominal pain and abdominal pelvic fluid collection.Multiple imaging studies were done over that time and a procedure to drain fluid from the patient¿s abdomen was completed on (b)(6) 2019.The procedure was completed with no complications.Additional imaging studies and visits to their hcp were completed between on (b)(6) 2019 due to back pain while sitting and activity related pain.The patient reported that their next revision surgery was scheduled for on (b)(6) 2019.
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