Model Number TPL0059 |
Device Problems
Imprecision (1307); Mechanical Problem (1384); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2023 |
Event Type
malfunction
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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 site aborted the use of the guidacne system during the case.The case was a single level percutaneous case to follow single level olif.At first they had difficulty registering and segmentation was off.They eventually got green values on the levels they were working on but when they sent the arm it l5-left went in the wrong direction.The path of the screw was at a completely incorrect angle.The path seemed to be vertically mirrored to the plan.They did not drill or place a screw.They did not complete an accuracy test as the surgeon decided to abort use of the guidacne system and to continue the case manually.No confirmation of the issue was completed.The issue extended the surgical time by less 1 hour.There was no impact on the patient outcome.
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Manufacturer Narrative
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H3: a manufacturer representative went to the site to test the system.The manufacturer representative performed calobrations on joint 3 of the surgical arm.The system then worked as intended.The surgical arm was not replaced.The export and log data files are currently under analysis.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: asm0206, serial/lot #: (b)(6).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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H2) the investigating team reviewed the export and log data files and all the available information and concluded the root cause of the inaccuracy of left l5 to be a platform shift due to poor attachment of the schanz pin to the bone.The offset and angle of trajectory fit an inferior movement of the platform.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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