A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.
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A site representative reported that, while in a spinal fusion, an imprecision was observed when a confirmation found that the left hand side screws in the t11-t12 vertebrae were imprecise medially.The surgeon opted to complete the procedure without the use of the navigation system.The surgeon then switched from minimally invasive to open to remove hardware and complete the procedure.The imprecision resulted in a 50% sensory loss in the patient per neuro monitoring.Following the procedure, there was no violation of the dura that occurred.The patient has since been reported to be able to move all four extremities.No additional information was provided.
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