Patient information was requested but has not been provided.The bent instrument was received on 04-22-2016, and a functional evaluation was performed.The instrument was confirmed to have a bent tip, but it was still found to be fully functional.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.No further issues have been reported from the site of this nature.
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A medtronic representative reported that during a spinal fusion case, a probe was found to be bent but was still allowed to be verified by the system.The instrument navigated fine.No further details regarding the damage, or how it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.
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