Medtronic (MDT) issued a Safety Notice related to use of non-Medtronic instruments with the NavLock™ Tracker, an accessory to its StealthStation Surgical Navigation system. NavLock enables navigation of instrumentation during spinal fusion and interbody procedures.
The notice indicates MDT's awareness of minor and serious injuries, including two patient deaths, following use of non-MDT instruments with NavLock. As a result, MDT will update product labeling to clarify the use of non-MDT instruments with this device, revising Indications for Use and including a strengthened warning.
To date, FDA has reviewed and cleared surgical stereotaxic navigation instruments produced by non-MDT manufacturers for use with StealthStation. Among these, instruments from Alphatec Spine, Globus Medical and Orthofix have been cleared for use with the NavLock Tracker on StealthStation. These third-party instruments were cleared based on non-clinical performance data submitted to FDA by their manufacturers.
Between January 1, 2013 and March 22, 2017, FDA has identified 196 medical device reports (MDRs) associated with the use of NavLock Tracker. Due to limited information available in the MDRs, it is unclear if and to what degree the use of 3rd party instruments caused or contributed to adverse events. Further, FDA has noted that contributing factors associated with accuracy and precision problems when using stereotaxic navigation systems are multifactorial.
To date, there are no reports of patient death associated with the use of NavLock Tracker when MDT's or FDA-cleared surgical stereotaxic instruments from third-party manufacturers were used.