MSD DEGGENDORF MFG CLYDESDALE PTC¿ SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
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Model Number 4986850 |
Device Problems
Break (1069); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2021 |
Event Type
malfunction
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Event Description
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Information was received from healthcare provider (hcp) via a manufacturer representative regarding an event happened during intra-op for a patient undergoing l2-l5 olif.The pre-op diagnosis was mentioned as "degenerative lumbar scoliosis".It was reported that, in the case of l2-5 olif, after the olif was performed at l4 / 5 and l3 / 4, the cage did not enter at all from the middle during the olif of l2 / 3.The cage could no longer be tapped and inserted, and the inserter could not be attached because the thread part of the cage was broken.They used a remover, but the cage did not move at all. finally they grabbed the cage with luer and managed to remove it.They replaced it with a new cage, but the second cage had the same event and was removed by the same means.There was a delay of more than 60 minutes reported as a result.No fragments of broken cages remained in patient.There were no symptoms to patient or physician were reported.No further complications reported regarding the event.
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Manufacturer Narrative
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Evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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H3: product analysis of part# 4986850 ; lot# h5670249 analysis summary: visual and microscopic examination identified the threads of the inserter interface to be stripped off, with evidence of deformation on the face of the implant or hole diameter.The nose of the implant as witness marks in the center.The above observations are consistent with significant impact during attempted assembly.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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