May 2, 2017
Dear Health Care Provider,
The FDA is providing information related to adverse events reported during or following procedures that involved the use of non-Medtronic surgical stereotaxic navigation instruments with Medtronic's NavLock Tracker. Medtronic's NavLock Tracker, an accessory to Medtronic's StealthStation Surgical Navigation System, enables navigation of instrumentation used during spinal fusion and interbody procedures.
On May 1, 2017, Medtronic issued a communication to consumers related to the use of non-Medtronic instruments with Medtronic's NavLock Tracker. This notice reports that Medtronic is aware of occurrences of minor and serious injuries, including two patient deaths, following procedures that involved the use of non-Medtronic instruments with Medtronic's NavLock Tracker. As a result, Medtronic notified the Agency of plans to update its product labeling to clarify the use of non-Medtronic instruments with its NavLock Tracker. Per Medtronic's communication, the "Indications for Use" and "Warning" statement found in the labeling of the NavLock Tracker will be updated to state:
Revised Indications for Use: "The NavLock Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the Medtronic StealthStation surgical navigation system. The NavLock Trackers should only be used with Medtronic instruments."
Strengthened Warning: "The NavLock Tracker is designed and tested for use only with Medtronic instruments. The use of non-Medtronic instruments with NavLock Tracker may result in inaccuracy, leading to serious injury or death."