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:
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:
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