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The U.S. Food and Drug Administration reports that Medtronic has issued a safety communication regarding the use of non-Medtronic instruments with the company’s NavLock Tracker.
The company states that NavLock Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the Medtronic StealthStation surgical navigation system, and should only be used with Medtronic instruments. The safety communication notes reports of minor and serious injuries—including two patient deaths—following procedures that involved the use of non-Medtronic instruments with Medtronic's NavLock Tracker. Learn more...
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