Medtronic received information regarding a guidance system being used during a spinal procedure to treat degenerative disc with fixation.It was reported that during a l4-s1 revision case, the right l5 screw deviated from the planned trajectory.The screw was deviated approximately two mm inferior.The manufacturer representative thought surgical technique of working on the opposite side of screw placement caused the deviation.The patient did experience some discomfort and they had developed a cyst in the same area of the screw after the surgery.The screws were repositioned on (b)(6)2020 using navigation to assist with the discomfort.The surgeon indicated that it was unknown whether it was the screw, cyst or both that caused the problem.There was no patient harm and the procedure was delayed less than an hour.
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H3: software exports were analyzed and the complaint was confirmed.Clinical export data file was thoroughly inspected.The log file was examined with respect to all intraoperative fluoro images in order to inspect and understand procedure workflow.Analysis reviewed the planning of this case.In all the trajectories the screws midline which represents the drill pathway is planned through the facet and near a cortical slope.Though this did not cause the reported deviation, it is recommended to avoid planning through the facet as it can lead the drill to deviate from planning.As for l5 right, an inferior skiving potential does exist and can be seen from the lateral view.Analysis reviewed the provided ap and obl images.Registration was verified to be accurate.When reviewing the post-op images of this case, it was confirmed that l5 left indeed was subjected to inferior deviation.As can be seen in the post-op images, the screw has a more superior-to-inferior angle (from the lateral view) than was initially planned, which suggests skiving as the cause for the deviation.Executing trajectories from the contra-lateral side is less recommended and may have been a contributing factor to the reported deviation.Analysis reviewed all available information and concluded that the root cause for the deviation at l5 right was skiving of the surgical tools.The l5 screw was planned with an inferior skiving potential, which matches the actual deviation of the screw.The fact that the surgeon executed the left side screws from the contra-lateral side may serve as a contributing factor.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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