Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that navigation of the cannula and dilator was off during a l2-l4 right psis fixation procedure.After registration was completed, the patient had a coughing fit which caused movement.A new snapshot was done and navigation and guidance system accuracy was confirmed.The surgical arm was sent to the first trajectory and the cannula and dilator were placed down the arm guide, but navigation was off.Navigation of the drill was accurate.The issue occurred with all trajectories, but the screws were able to be placed accurately.After the procedure, the instruments were checked and they were not damaged.The instruments were able to be navigated accurately during the next procedure.The cause of the navigation inaccuracy was not determined.There was no patient harm and the procedure was delayed less than an hour.
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H3: analysis of the software exports and logs found there was insufficient information to determine whether a software anomaly contributed to the reported behavior.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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