FDA Warns About Adverse Events with Medtronic’s NavLock Tracker

FDA is warning users of Medtronic’s NavLock Tracker device not to use non-Medtronic surgical stereotaxic navigation instruments due to the potential for increased adverse events. The NavLock Tracker, an accessory to Medtronic's StealthStation Surgical Navigation System, enables navigation of instrumentation used during spinal fusion and interbody procedures, according to an agency notice.

On 5/1, Medtronic issued a communication related to the use of non-Medtronic instruments with Medtronic's NavLock Tracker and their association with occurrences of minor and serious injuries, including two patient deaths. As a result, Medtronic told the agency it plans to update product labeling to clarify the concern.

FDA says it has identified a total of 196 medical device reports associated with the use of NavLock Tracker, but it says it is unclear if, and to what degree, the use of third-party instruments caused or contributed to an adverse event.