May 2, 2017

Dear Health Care Provider,

The FDA is providing information related to adverse events reported during or following procedures that involved the use of non-Medtronic surgical stereotaxic navigation instruments with Medtronic's NavLock Tracker. Medtronic’s NavLock Tracker, an accessory to Medtronic's StealthStation Surgical Navigation System, enables navigation of instrumentation used during spinal fusion and interbody procedures.

On May 1, 2017, Medtronic issued a communication to consumers 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."

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., 3^rd party instruments) were cleared based on non-clinical performance data submitted to the FDA by those manufacturers.

Between January 1, 2013 and March 22, 2017, the FDA has identified a total of 196 medical device reports (MDRs) associated with the use of Medtronic’s NavLock Tracker. The table below summarizes the adverse event types described in those reports, including reports that reference the use of 3^rd 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 3^rd 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.

MDRs Associated with the use of Medtronic’s NavLock Tracker
January 1, 2013 – March 22, 2017

The two deaths noted in the table above involved patients undergoing a spinal procedure and experiencing post-operative hemorrhage. These two patient deaths occurred following a procedure that involved the use of 3^rd 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 3^rd 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.

FDA RECOMMENDATIONS

The FDA recommends health care providers:

• 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 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.
• Report any adverse events related to the use of Medtronic’s NavLock Tracker that come to your attention. If you suspect a problem, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
  • When submitting a report to the FDA, please include information related to the brand and model of all instruments used during the procedure, and what instruments were being used at the time the patient injury occurred or was suspected to have occurred. Please also provide any information on how navigation accuracy was assessed before and during the use of the instruments.

FDA ACTIONS

The FDA continues to work with Medtronic and other manufacturers to better understand the safety and effectiveness of 3^rd party instruments with the use of Medtronic’s NavLock Tracker, and will keep the public informed if significant new information becomes available.

CONTACT US

If you have questions about this communication, please contact CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], 800-638-2041, or 301-796-7100.

Sincerely,
/s/
William Maisel, MD, MPH
Deputy Center Director for Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration