The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning NavLock Tracker, manufactured by Medtronic.

On 1 May 2017, the manufacturer 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. 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."

Between 1 January 2013 and 22 March 2017, the FDA identified a total of 196 medical device reports (MDRs) associated with the use of Medtronic's NavLock Tracker. However, 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 the adverse event. Additionally, the FDA recognizes that the contributing factors associated with accuracy and precision problems when using stereotaxic navigation systems are multi-factorial.

The two deaths noted involved patients undergoing a spinal procedure and experiencing post-operative hemorrhage. These two patient deaths occurred following a procedure that involved the use of 3rd party surgical stereotaxic navigation instruments that have not been cleared by the FDA for use with Medtronic's NavLock Tracker on Medtronic's StealthStation.

To date, the FDA has reviewed and cleared surgical stereotaxic navigation instruments produced by manufacturers other than Medtronic for use with Medtronic's StealthStation. Among these are instruments manufactured by Alphatec Spine, Inc., Globus Medical, Inc., and Orthofix, Inc. which have been cleared for use with Medtronic's NavLock Tracker on Medtronic's StealthStation. The instruments from these manufacturers (e.g., 3rd party instruments) were cleared based on non-clinical performance data submitted to the FDA by those manufacturers.

The FDA has provided the following recommendations:

• Do not use surgical stereotaxic instruments that have not been cleared by the FDA for use with Medtronic's NavLock Tracker on the Medtronic StealthStation Surgical Navigation System.
• Be aware of Medtronic's communication disclaimer icon related to the use of non-Medtronic surgical stereotaxic instruments with Medtronic's NavLock Tracker.
• When using any surgical stereotaxic instruments, be aware that surgical accuracy should be assessed repeatedly throughout a procedure when using a surgical navigation system by positioning the navigated instrument tip on an identifiable anatomical landmark and comparing the actual tip location to that displayed by the system.
• Be aware that not all surgical instruments are appropriate for surgical navigation. Consider using surgical stereotaxic instruments that are identified as compatible with the surgical navigation system being used.

For details, please refer to the FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm556432.htm
https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm556052.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 4 May 2017