Model Number TPL0059 |
Device Problem
Imprecision (1307)
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Patient Problem
Perforation (2001)
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Event Date 04/12/2023 |
Event Type
Injury
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Manufacturer Narrative
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H3, h6: the exports have been returned for clinical analysis.The analysis is still in progress.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 there was an alleged inaccuracy during a case.The scope of the case was from t5 to t10, but t7 was skipped.The patient was in a prior event that caused a complete spinal separation at t7 causing the patient to be permanently paralyzed.The surgeon has stated that there was nothing that could have been done to recover the patient's current spinal state.The case was a scan and plan procedure.The surgeon placed all the screws on the right and left sides from t5 to t10 and was about to confirm placement.However, after taking the ap scout shot, the surgeon immediately determined that all of the screws were not according to plan.All left screws were lateral and the right screws were medial.Some were worse than others.The surgeon only used the ap shot to determine that the screws were off.The manufacturer representative stated that some screws went straight into the spinal cord canal.The representative felt that they had kept close attention to the entire case and that everything was perfect.The surgeon decided to replace all screws using navigation.Once they completed the repair, they did not take a spin or scout shots to confirm the correct screw placement.
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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 procedure was delayed roughly an hour.The traj ectories were deviated between 3.5 and 10mm.There was no impact on patient outcome after the procedure.
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Manufacturer Narrative
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H2) the clinical investigating team reviewed all the available information and export/log data files and concluded that the probable root cause of laterally deviated left screws and medially deviated right screws is a patient shift due to the waterbed effect.It is possible that due to the patient's high bmi and since the surgeon operated on the patient's left side, the surgeon leaned on the patient and may have pushed the patient, resulting in all left screws deviating laterally and all right screws deviating medially.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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