Model Number 55750046540 |
Device Problems
Use of Device Problem (1670); Migration (4003)
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Patient Problem
Unspecified Nervous System Problem (4426)
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Event Date 10/17/2022 |
Event Type
Injury
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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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It was reported that after the procedure the screws were deviated.There is a possibility of l5 root symptoms after surgery and prolonged hospitalization to fix again through revision surgery.No further complications or symptoms were reported.Additional information has been received via manufacturer representative that all the reported screws were deviated after initial surgery and were explanted in the revision surgery.The lot numbers of the reported products are unknown.Additional information has been received via manufacturer representative that as a result of the verification, it became clear that it was a human error.In a lateral decubitus position, a cage was inserted using the olif at this hospital, and then the percutaneous pedicle screw (pps) was performed as is in a lateral decubitus position.Upon navigation after the cage insertion, the vertebral body moves due to the cage, so the o-arm imaging was performed again navigation was used; accidentally selected the o-arm imaging data before inserting the cage on the navigation even during pps, and the screw was inserted unnoticed as is.Therefore, it was decided that even though the screw insertion was accurate on the navigation system, it was actually deviating.Re-operation was completed successfully.
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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 has been received via manufacturer representative that the 3 dislodged screws were re-implanted in the revision surgery.The products will not be returned as they are implanted.
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Search Alerts/Recalls
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