The site declined to provide patient information, per (b)(4) privacy laws.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested for suspect active stealth fighter inst.No parts have been received by manufacturer for analysis.On 03/01/2016 a medtronic representative, following-up at the site, confirmed the instrument was fractured during use.
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A medtronic representative reported that, while in a posterior spinal fusion procedure, the site's awl / probe / tap (apt) experienced recognition failure.The connector part was manipulated and the reported apt re-gained recognition normally.The surgeon opted to continue the procedure.After this issue, a good site was found to connect in order to continue, as the cable was partly fractured.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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