Model Number BI70002000 |
Device Problems
Imprecision (1307); Data Problem (3196)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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System checkout hasn't been performed.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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Medtronic received information regarding an imaging system during an open spinal fusion procedure.It was reported that during a case, the site took two spins, one for l4, l5, s1, and iliac and the other for l2 and l3.The surgeon navigated the first spin for l5, s1, and iliac and everything was accurate, he did start at the vertebral body closest to the perc pin instead of furthest away.When the surgeon went to navigate the spin for l2 and l3, they noticed right away there was 1 cm shift.The left side of the anatomy looked 1 cm later while the right looked 1 cm medial, but they remained congruent.The surgeon went ahead and placed the screws without navigation for l2 and l3 because it was an open spinal fusion.They went ahead and took another spin before placing the interbodies, and everything was accurate and they were able to place the interbodies with navigation.The probable cause was noted to be an anatomy shift or bumped perc pin.There was no delay in surgery.There was no impact on patient outcome.
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Manufacturer Narrative
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Continuation of d10: section d information references the main component of the system.Other relevant devices are: product id bi-500-01145, software version: 4.2.0.H3, h6: a system checkout was performed, the tracking procedure was completed and verified as accurate.There was no failure found.B01, c19, and d14 are applicable.H3, h6: software analysis was completed.No failure was found.B01, c19, and d14 are applicable.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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