NEOCIS GUIDANCE SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT DURING A DENTAL IMPLANT PROCEDURE WITH THE NEOCIS GUIDANCE SYSTEM (NGS), THE SURGEON ATTEMPTED A VERTICAL SINUS LIFT WITH INCREASED IMPLANT HEIGHT BY 3MM USING DRILLS IN REVERSE. DURING THE PROCEDURE, THE SINUS MEMBRANE RESISTANCE WAS NOT FELT RESULTING IN PERFORATION. THE SURGEON BONE GRAFTED AND SUTURED THE SITE TO PREVENT FURTHER INJURY. THE IMPLANT WAS NOT PLACED AND THE PATIENT WILL RETURN AT A LATER DATE FOR THE IMPLANT PLACEMENT. NO ADDITIONAL INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. THE PROCEDURE IS NOT AN APPROVED INDICATION FOR USE. THIS ISSUE IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.