Site dr.(b)(6) declined to provide patient information.Procode, common device name and/or 510(k) provided as this device is not released for distribution in the united states. on 04/20/2017 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.- a medtronic representative, following-up at the site, confirmed that the surgeon had to reposition the screws and used a c-arm/fluoro to do so.- on 05/11/2017 software analysis was unable to determine probable cause with the information provided.Reported issue could not be replicated.
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A medtronic representative reported that while in a interbody fusion procedure, the surgeon alleged an inaccuracy occurred.After images were taken using the imaging system, a navlock was attached to a voyager driver, however, it did not verify.Passive markers were replaced with new ones to verify but the recognition failure issue persisted.Multiple attempts were made to verify and were successful.After screws were positioned, it was confirmed that all screws were deviated.The surgeon repositioned the screws with the use of a c-arm/fluoro.Delay in therapy was less than one hour.
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