Model Number TPL0059 |
Device Problem
Imprecision (1307)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/04/2021 |
Event Type
malfunction
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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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Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that the left side of a l2/l3 procedure was completed without issue.When the surgeon was navigating with the drill on right l3, the drill was 3 mm inferior and the patient started "jumping".The event may have impacted the patient's motor function, but they were stable.The surgeon exposed further, but then decided to abort the use of the guidance system.The procedure was completed freehand.The procedure was delayed less than an hour.The manufacturer representative was not sure what caused the trajectory and drill to be inferior.An accuracy test after the procedure was done and the system passed.
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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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Event Description
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After noticing the drill was 3mm inaccurate, the surgeon did not continue to use the robot.The left sided screws were done first before the right sided screws.Once drilling for the right sided l3 the patient jumped and the surgeon stopped drilling.He then exposed further so that he could see where the hole was.After exposing further was when he noticed the hole was 3mm inaccurate.At that point the surgeon aborted robotic use.
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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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Event Description
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Additional information was received stating that no c-arm images were taken.There was also no impact on the patient outcome.The patient woke up okay with full motor function.
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Search Alerts/Recalls
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