Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.The representative reported that calibrations were required and performed on the navigation system.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced, therefore no parts were returned for analysis.
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A medtronic representative reported that, while in a spinal fusion, an imprecision was observed.The imprecision was noted to be 1cm in the sagittal direction.The reported issue occurred while navigating.No additional information was provided.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.
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