FDA: Safety alert for Medtronic’s NavLock Tracker

Editor's Note

The Food and Drug Administration (FDA) on May 3 issued a Safety Alert for Medtronic’s NavLock Tracker.

Medtronic has received 196 medical device reports that included two patient deaths after procedures in which non-Medtronic instruments were used with the NavLock Tracker.

The NavLock Tracker enables navigation of Medtronic instrumentation during spinal fusion and interbody surgical procedures with the Medtronic StealthStation surgical navigation system.

Medtronic is updating its product labeling to clarify that only Medtronic instruments should be used with the NavLock Tracker.

Posted 05/03/2017] AUDIENCE: Risk Manager, Surgery, Orthopedics ISSUE: On May 1, 2017, Medtronic issued a communication 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.