Model Number TPL0059 |
Device Problem
Imprecision (1307)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2022 |
Event Type
malfunction
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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 the navlocks showed to be slightly inaccurate, approximately 1 mm.The manufacturer representative re-registered the guidance system and reoriented the camera to resolve the issue.The issue extended the surgical time by less than 1 hour.There was no impact on the patient outcome.No new information.Additional information was received stating that four navlocks were showing inaccurate.The cause or suspected cause of the navlocks showing inaccurate was not determined.Once the guidance system was reregistered and the camera was reoriented the navlocks were still showing to be slightly off.The surgery was able to be completed successfully.Navigation was slightly off on the screen only, but the surgeon was using fluro to check the accuracy.The case was completed with the same navlocks under fluoro check.
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Manufacturer Narrative
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The surgical arm was replaced and returned for analysis.Analysis determined that multiple hardware and electrical failures were found with the surgical arm.Other relevant device(s) are: product id: asm0206-01s, serial/lot #: (b)(4), product id: 9736060k, serial/lot #: unk, product id: 9736061k, serial/lot #: unk, product id: 9734907, serial/lot #: unk, product id: 9734914, serial/lot #: unk.Fda codes: b01, c13 pertain to product id: asm0206-01s fda codes: b17, c20 pertain to product id: 9736060k, 9736061k, 9734907, 9734914.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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H2: a1, updated.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9736060k, lot#: 190801 product id: 9736061k, lot#: 190718, product id: 9734907, lot#: 111201, product id: 9734914, lot#: 200407.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.
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Search Alerts/Recalls
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