Model Number TPL0059 |
Device Problem
Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Export files have been received however, analysis has not yet been completed.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 there was an inaccurate screw placement.During a t9 down to l2 percutaneous case, they did two registrations because they split the ct up.The first was t9 to l1, then the second went down to l2.The first registration looked good but when they moved down to l2, the left screw was placed medial and the right screw was also placed medial (in the pedical, but medial).Troubleshooting involved recalibrating the c-arm.The issue extended the surgical time by less than 1 hour.The amount of deviation was unknown.
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Manufacturer Narrative
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H2) additional information: a1-a5) patient information provided.H3) after eliminating sub-optimal planning, patient or platform shift, and registration was verified to be accurate, the investigating team has reviewed all available information and concluded the most probable cause of the deviation of bilateral l2 trajectories sub-optimal surgical technique, which have resulted in medially deviated trajectories, as the tools were most probably subjected to soft-tissue pressure.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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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 received from a manufacturer representative reported that the screws were deviated between 3.5 and 10 mm.
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Search Alerts/Recalls
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