Catalog Number 9734680 |
Device Problems
Bent (1059); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was unavailable from the site.Lot no., udi and manufacture date not available for this instrument at time of filing.A system checkout was not required as resolution of the issue was confirmed at the time of the event.Part not returned.
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Event Description
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Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.The issue occurred intraoperatively while navigating and caused no delay to surgery.It was reported that the tip of the thoracic probe was bent during the surgery.The surgeon completed the surgery with the thoracic probe and navigation.There was no impact on patient outcome.
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Manufacturer Narrative
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Additional information: device lot number, unique device identification (udi) and manufacture date provided.The probe was returned to the manufacturer for evaluation.Testing found that the tip of the probe was twisted and there were impact marks noted on the back end of the probe, resulting in fit issues.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.
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Search Alerts/Recalls
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