MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramNavLock Tracker by Medtronic: Letter to Healthcare Providers - Patient Injuries ReportedAUDIENCE: 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. 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 January 1, 2013 and March 22, 2017, the FDA identified a total of 196 medical device reports (MDRs) associated with the use of Medtronic’s NavLock Tracker. See the Letter to Healthcare Providers for a table summarizing the adverse event types described in those reports, including reports that reference the use of 3rd party surgical stereotaxic navigation instruments during the surgical procedure. 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 multifactorial. 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, there are no reports of patient death associated with the use of Medtronic’s NavLock Tracker when Medtronic or FDA-cleared surgical stereotaxic instruments from 3rd party manufacturers were used. The majority of injuries reported to the FDA associated with the use of Medtronic’s NavLock Tracker, regardless of the manufacturer of the surgical stereotaxic navigation instrument used, involved spinal injury due to misaligned or misplaced screws. BACKGROUND: Medtronic’s NavLock Tracker, an accessory to Medtronic's StealthStation Surgical Navigation System, enables navigation of instrumentation used during spinal fusion and interbody procedures. 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. RECOMMENDATIONS:
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