MEDTRONIC SOFAMOR DANEK USA, INC T2 STRATOSPHERE¿ EXPANDABLE CORPECTOMY SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
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Model Number 436025C |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2024 |
Event Type
Injury
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Event Description
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Information was received from a healthcare professional via a manufacturer representative regarding a patient with procedure for l1 lateral corpectomy (replacement of vertebral body with expandable cage).It was reported that the implant appeared to have broken teeth on the expandable element, which stopped the implant from being used in a normal fashion.Implant would not raise to required height and on inspection and explant, seemed to be defective.This implant was replaced by another, smaller implant.There was no patient symptoms or complications as a result of this event.
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Manufacturer Narrative
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B2.There was a change in the size of implant that was used to complete the surgery.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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