Model Number TPL0059 |
Device Problem
Imprecision (1307)
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Patient Problem
Paralysis (1997)
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Event Date 12/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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A.Patient information, unavailable.Export data files have been received for review/analysis.Pending analysis at the time of submission of this report.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 a guidance system being used during a spinal procedure.It was reported that during a t8 l2 case with a solera voyager, the guidance system was attached using mist bridge with two pins in t10 and t12.Two ct to fluoro registration were done.One for t8 and t9 and one for l1 and l2.At the end of the surgery, all the screws were deviated to the right, causing breach in the canal.T8 was pathogen as the canal breach created an oedema.The patient was impacted and under surveillance with left leg paralysis symptom.The patient had a high bmi, the table was slightly tilted to the left at the beginning of the case before connecting the mist bridge to the guidance system but no patient movement was detected during the case and during the two registrations.Additional information received from a manufacturer representative reported that the deviation was between 3.5 and 10 mm.
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Manufacturer Narrative
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H3: export data files were reviewed for analysis.Based on all available information, considering the patient's high bmi, bed tilt and lack of cushioning in the bed, it was concluded the root cause of the deviation in the operating room was due to patient movement.The described setup of the high-bmi patient on the tilted bed without adequate restraining, caused the patient's body to slide by a few mm to the left in each trajectory independently, which, in turn, caused the right deviations.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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