Model Number TPL0059 |
Device Problems
Imprecision (1307); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2023 |
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 after registering a patient for a revision case, the small cannula tool used for verification was off by approximately 5 cm in the y-direction and floating in space when inserted it into the arm guide.However, when using the passive planar instrument to confirm the inaccuracy, they found the instrument to track 5 cm below the expected target.Since this was a revision case, the patient already had hardware in l4 and l5.Registration to l4 failed due to the hardware, so l3 was used for registration instead.They decided to reperform the registration process from scratch after the inaccuracy, and this time they went straight to l3 for registration.Registration was successful and the manufacturer representative noted that nothing looked different on the monitor from the first registration, but that every verification showed to be accurate.The case continued after the successful second registration and screws were placed accurately without issues.The delay was approximately 15 min.There was no impact to the patient outcome.
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Manufacturer Narrative
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H3: a manufacturer representative went to the site to test the system.The manufacturer representative performed calibrations on joint 3 of the surgical arm.The system then worked as intended.The surgical arm was not replaced.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: asm0206, serial/lot #: (b)(6).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) patient information provided.Weight unknown.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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