MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number 9735665 |
Device Problem
Imprecision (1307)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 09/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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Patient information not provided due to canadian patient privacy regulations.No parts have been received by the manufacturer for evaluation.Other relevant device(s) are: product id: 9735740, serial/lot #: (b)(4).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 navigation system being used during a t2-t5 scoliosis procedure.It was reported that a five millimeter imprecision was observed in the lateral direction at t2.It was noted that prior to the inaccuracy, screws were placed at t3-t5 without issue.A c-arm was brought into the operating room (or) to confirm the positioning of t2 screws as well as the other screws and the physician indicated they believed the screws were all inaccurate in the lateral direction.It was noted that the reference frame was placed at t5 and there were no indications the unit moved.The surgeon elected to revise all screws due to the imprecision. the surgeon opted to complete the procedure without the use of the navigation system. there was a reported delay to the procedure of less than 1 hour due to this issue.
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Event Description
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Additional information was received stating that it was the wrong disk and the system has software on it and was operating.
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Manufacturer Narrative
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Additional information was added to the event description.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: the logs from the navigation system were returned to the manufacturer for evaluation.Analysis found that the logs contained ins ufficient information to determine the relationship of the software to the reported issue.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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