NavLock Tracker Safety Notice

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Not Medtronic's fault.

A medtronic representative reported that during a spinal fusion procedure, the tracker instrument became stuck in a nuvasive driver. The screwdriver became stuck and would no longer rotate; they were unable to disengage the navlock tracker from the nuvasive driver. The surgeon used a nuvasive non-navigated driver to remove the ***** and then replaced it with the nuvasive non-navigated driver. The medtronic representative informed the surgeon this was an off-label use of the navlock tracker instrument. The medtronic representative noted that the surgeon and staff had been cautioned numerous times of the risk of using nuvasive with the navlock tracker instrument. The surgeon opted to complete the procedure without the use of the navigation system.

Surgeons are so stubborn but then blame us when things go wrong.

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Call the DOJ.

Not Medtronic's fault.

A medtronic representative reported that during a spinal fusion procedure, the tracker instrument became stuck in a nuvasive driver. The screwdriver became stuck and would no longer rotate; they were unable to disengage the navlock tracker from the nuvasive driver. The surgeon used a nuvasive non-navigated driver to remove the ***** and then replaced it with the nuvasive non-navigated driver. The medtronic representative informed the surgeon this was an off-label use of the navlock tracker instrument. The medtronic representative noted that the surgeon and staff had been cautioned numerous times of the risk of using nuvasive with the navlock tracker instrument. The surgeon opted to complete the procedure without the use of the navigation system.

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Wow, pretty awesome a nuvasive rep is trying to get customers to use our products off label. The best part is we are the ones getting the slap on the wrist, not the nuvasive reps.

Call the DOJ.

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MEDTRONIC NAVIGATION, INC. NAVLOCK TRACKER UNIVERSAL ORANGE ORTHOPEDIC STEREOTAXIC INSTRUMENTBack to Search Results
Catalog Number 9734683
Device Problems Mechanical issue; Device Issue; Mechanical jam
Event Date 04/10/2014
Event Type Injury
Event Description

A medtronic representative reported that during a spinal fusion procedure, the tracker instrument became stuck in a nuvasive driver. The screwdriver became stuck and would no longer rotate; they were unable to disengage the navlock tracker from the nuvasive driver. The surgeon used a nuvasive non-navigated driver to remove the screw and then replaced it with the nuvasive non-navigated driver. The medtronic representative informed the surgeon this was an off-label use of the navlock tracker instrument. The medtronic representative noted that the surgeon and staff had been cautioned numerous times of the risk of using nuvasive with the navlock tracker instrument. The surgeon opted to complete the procedure without the use of the navigation system.

Manufacturer Narrative

Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k). This mdr is being submitted to correct this information. There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.

Manufacturer Narrative

Mfg date provided. This issue was reviewed by hardware engineers. It was found that the part used with the medtronic navigation inc. , tracker was not a medtronic part. Instructions for use do not support use of this product with other manufacturer's products.

Manufacturer Narrative

Device lot number, or serial number, not available at time of this report. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable at this time. Rma issued. Replacement device shipped to site (b)(4) 2014. No parts have been received by the manufacturer for analysis. Not returned to manufacturer.

Wow, pretty awesome a nuvasive rep is trying to get customers to use our products off label. The best part is we are the ones getting the slap on the wrist, not the nuvasive reps.

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Nuvasive

MEDTRONIC NAVIGATION, INC. NAVLOCK TRACKER UNIVERSAL ORANGE ORTHOPEDIC STEREOTAXIC INSTRUMENTBack to Search Results
Catalog Number 9734683
Device Problems Mechanical issue; Device Issue; Mechanical jam
Event Date 04/10/2014
Event Type Injury
Event Description

A medtronic representative reported that during a spinal fusion procedure, the tracker instrument became stuck in a nuvasive driver. The screwdriver became stuck and would no longer rotate; they were unable to disengage the navlock tracker from the nuvasive driver. The surgeon used a nuvasive non-navigated driver to remove the screw and then replaced it with the nuvasive non-navigated driver. The medtronic representative informed the surgeon this was an off-label use of the navlock tracker instrument. The medtronic representative noted that the surgeon and staff had been cautioned numerous times of the risk of using nuvasive with the navlock tracker instrument. The surgeon opted to complete the procedure without the use of the navigation system.

Manufacturer Narrative

Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k). This mdr is being submitted to correct this information. There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.

Manufacturer Narrative

Mfg date provided. This issue was reviewed by hardware engineers. It was found that the part used with the medtronic navigation inc. , tracker was not a medtronic part. Instructions for use do not support use of this product with other manufacturer's products.

Manufacturer Narrative

Device lot number, or serial number, not available at time of this report. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable at this time. Rma issued. Replacement device shipped to site (b)(4) 2014. No parts have been received by the manufacturer for analysis. Not returned to manufacturer.

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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 communicationdisclaimer icon 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."

The Use of Non-Medtronic Devices with Medtronic’s NavLock Tracker– Letter to Health Care Providers

Letter to healthcare providers regarding Medtronic's NavLock Tracker.

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Your email address will never be used for any other reason and will never be sold to email marketers.

A reason is required.