Unique device identification (udi) is not available.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.
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Medtronic received information regarding a navigation system.It was reported that intra/peri-operatively during the navigate task of a sacroiliac and thoracolumbar procedure, the site used an orange tracker and a driver and it was accurate, however; during the case calibration was lost.The site chose to use a tracker with the grey on the driver.The site stated it wasn't loose and after investigating the orange tracker it had been heavily used.There was no delay to the procedure.No known impact on patient outcome.
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