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Model Number 9560524 |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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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Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having med for lumbar disc herniation.It was reported that the dial (ring) connecting the flexible arm assembly and the tubular tractor was hard, so it could not be tightened.There were no problems with the pre-operative checkup before the operation, and it did not move when it was being used during the surgery.It was sterilized with a slight loosening, so the tubular tractor was able to be connected somehow.It was still hard after the surgery, but when it was washed for verification, it was reconfirmed and it returned to a smooth state. there was no patient symptom reported.There was a delay in the procedure by less than 60 minutes.There were no further complications reported regarding the event.
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Manufacturer Narrative
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Product analysis of part # 9560524, lot # my20e001: visual inspection revealed the flex arm was returned with no missing or disassembled components.Functional evaluation confirmed the flex was able to be tightened and loosened and the flex arm was able to maintain the position once tightened.The instrument functions as intended.No fault found.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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