MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
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Model Number BI70000027120 |
Device Problems
Imprecision (1307); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problems
Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3) no parts have been returned to the manufacturer for analysis.Codes: b17, c20, d15.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.
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Event Description
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Medtronic received information regarding a navigation device being used intra-operatively during a sacroiliac and thoracolumbar procedure.It was reported that a 1st spin was taken and the surgeon was navigating and placing screws but it felt off, took another spin and all the screws were placed medial and inferior.When the site went to take a second spin the imaging system had an error message stating that a problem occurred that will cause inaccuracy.Eventually the site was able to take the spin and it was still inaccurate.Brought in another imaging system and issue was resolved.There was a surgical delay of less than one hour.No known impact to patient outcome.
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Event Description
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Additional information was received.The inaccuracy amount was approximately 5-10 millimeters medially and inferiorly.The site performed three spins due to the inaccuracy, after the first spin was inaccurate, the site used the same imaging system to do another spine and it was still off so the site did not use that spin for navigation then brought in a different imaging system and spun again with that one and used that spine to navigate and it was accurate.Two unused spins total.The screws were removed then replaced after making new plans off the imaging system spin because the screws were in the wrong location from the original imaging system spin.
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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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