Regulatory Focus™ > News Articles > FDA, Medtronic Warn on Surgical Navigation Device

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Posted 03 May 2017 | By Michael Mezher 

FDA, Medtronic Warn on Surgical Navigation Device


Following reports of patient deaths and serious injuries, the US Food and Drug Administration (FDA) on Tuesday cautioned healthcare providers against using Medtronic's NavLock Tracker with instruments not cleared to be used with the device.

The NavLock tracker is an accessory to Medtronic's StealthStation surgical navigation system that is intended to be used to enable instrument navigation during spinal fusion and other procedures.

While FDA has cleared other devices, including instruments manufactured by Alphatec Spine, Globus Medical and Orthofix, for use with both the StealthStation and the NavLock Tracker, Medtronic says the NavLock Tracker should only be used with other Medtronic devices.

In updated labeling for the device, Medtronic says "the NavLock Tracker is designed and tested for use only with Medtronic instruments [and] should only be used with Medtronic instruments."

In total, FDA has identified 196 medical device reports linked to the NavLock Tracker since 2013. While the majority of the reports deal with malfunctions and do not reference the use of third-party instruments, the two reported deaths and a disproportionate number of reported injuries indicate that one or more third-party instrument was used during the procedure.

MDRs Associated with the use of Medtronic's NavLock Tracker (1 January 2013-22 March 2017
Event TypeTotal Number of MDRsMDRs that Reference the use of one or more 3rd party instrumentMDRs that do not reference the use of any 3rd party instrument
Serious Injury341123

However, FDA makes it clear that the two patient deaths happened after a procedure involving the use of third-party surgical stereotaxic navigation instruments that were not cleared for use with the NavLock Tracker or the StealthStation.

And, the agency notes, it is unable to determine if, or to what degree, the use of third-party instruments led to the adverse events due to the limited information included in the reports.

"FDA recognizes that the contributing factors associated with accuracy and precision problems when using stereotaxic navigation systems are multifactorial," the agency writes.

As such, the agency is recommending against using d

evices that are not cleared for use with the NavLock Tracker during procedures with the device, and reminds that surgical accuracy "should be assessed repeatedly throughout a procedure when using a surgical navigation system."

FDA, Medtronic


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