Medtronic notified the FDA of two patient deaths following spine surgeries where the NavLock Tracker was used with non-Medtronic instruments as part of the procedure.
The tracker serves as an accessory to the Medtronic StealthStation surgical navigation system, providing navigation during spinal fusion and interbody procedures.
Here are five things to know:
1. In the two patient death cases, third-party surgical stereotaxic navigation instruments were used with the NavLock Tracker.
2. No patient deaths have occurred when surgeons used the NavLock Tracker with Medtronic or FDA-cleared third-party manufacturer surgical stereotaxic instruments.
3. In response to the patient deaths and other injuries, Medtronic is strengthening the current warning and updating NavLock's product labeling, emphasizing that NavLock Trackers should only be used with Medtronic instruments. The company's existing warning on the product states: “The NavLock Tracker is designed and tested for use only with Medtronic instruments. Use with any unapproved instrument could compromise accuracy and safety.” The FDA reports the updated labeling will read:
• 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."
4. Medtronic reported the majority of injuries associated with the NavLock Tracker involved spinal injury because of misaligned or misplaced screws.
5. The FDA is aware of 196 medical device reports related to the NavLock Tracker between Jan. 1, 2013, and March 22, 2017. The association emphasizes, however, that "contributing factors associated with accuracy and precision problems when using stereotaxic navigation systems are multifactorial."