NavLock Tracker by Medtronic: Letter to Healthcare Providers - Patient Injuries Reported

[Posted 05/03/2017]

AUDIENCE: 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:

• 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 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:

• 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 communicationdisclaimer 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.
• 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/02/2017 - Letter to Healthcare Providers - FDA]
[04/28/2017 - Dear Doctor Letter - Medtronic]