Patient information was not made available from the site.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested.Replacement navlock universal green tracker shipped to site 11/16/2016.Return requested.Replacement tap 3.75 shipped to site 11/18/2016.No parts have been received by manufacturer for analysis.
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A medtronic representative reported that, while in a spine procedure, the site's green navlock tracker and their 3.75 solera tap became fused together when the surgeon was using these devices with a powerease drill.The surgeon stated that his glove may have gotten caught between the tap and the tracker, as well.The surgeon used a different tracker and a different tap combination to continue the procedure.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.
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