Deaths Prompt Medtronic to Update NavLock Tracker Device Label
UPDATED: Medtronic reached out to BioSpace with the following clarification:
Medtronic Emphasizes That It’s NavLock Tracker Should Not Be Used With Third Party Instruments
Medtronic notified the FDA of two patient deaths following spine surgeries where third party instruments were used with its NavLock Tracker 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.
The company’s current product warning statement 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 company is strengthening that warning and also updating the indications for use to state that NavLock Trackers should only be used with Medtronic instruments.
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.
Medtronic notified the FDA of two patient deaths following spine surgeries where the surgeon used its NavLock Tracker 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:
Medtronic Emphasizes That It’s NavLock Tracker Should Not Be Used With Third Party Instruments
Medtronic notified the FDA of two patient deaths following spine surgeries where third party instruments were used with its NavLock Tracker 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.
The company’s current product warning statement 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 company is strengthening that warning and also updating the indications for use to state that NavLock Trackers should only be used with Medtronic instruments.
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.
Medtronic notified the FDA of two patient deaths following spine surgeries where the surgeon used its NavLock Tracker 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: