Model Number TPL0059 |
Device Problem
Imprecision (1307)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2021 |
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 during a percutaneous t11-l3 fusion procedure, there was a screw deviation.There were no issues with setting up the guidance system for the procedure.The surgeon placed the screws on the right side without issue.The surgeon moved to t11 on the left side and navigation was a little deep; however, the surgeon was not concerned and placed the screw.The surgeon proceeded to t12 and navigation looked deep again.Another snapshot was taken and navigation looked good.No confirmation images were taken at this point and the surgeon finished placing screws.Once all of the screws were placed, a confirmation image was taken and all four screws on the left side were lateral to plan by 10 mm and into the transverse process.The surgeon removed the left sided screws, took an o-arm spin and placed the screws freehand.The cause of the deviation was not determined.There was no patient harm and the procedure was delayed over an hour.
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Manufacturer Narrative
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H3: a medtronic representative went to the site to test the equipment.Testing revealed that the surgical arm failed the stress test at j3.The surgical arm was recalibrated, but the test failed at j5.Additional troubleshooting and calibrations were done, but the surgical arm failed the stress test at j2.The surgical arm was replaced.The system then passed the system checkout and was found to be fully functional analysis results of the surgical arm were not available as of the date of this report.A follow up report will be submitted when analysis is complete.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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Manufacturer Narrative
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H3: analysis of the surgical arm found the complaint was confirmed.Visual/physical examination and functional testing found the jig test failed, the j2 bearing failed and the camera was the old version.The surgical arm was repaired, recalibrated and passed all testing.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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Search Alerts/Recalls
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