A medtronic representative reported that during a spinal fusion case, the surgeon experienced an inaccuracy while navigating a non-medtronic medicrea driver with a medtronic navlock tracker.The medicrea driver was tracking 10mm deeper into the anatomy than it was physically.The rep for medicrea was present and said the driver should track like a medtronic driver.The surgeon checked the medtronic passive planar and thoracic probe instruments and they all tracked accurately.This delayed the case briefly, but surgeon continued and took a post-op spin which showed the screws were placed correctly and there was no harm to the patient.After the case the medtronic navigation system hardware, software, and instruments were tested and all were found accurate and fully functional.C00140173.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
|