MGUIDE SET FOR SEVEN IMPLANT PROCEDURE

Additional Manufacturer Narrative

DENTSPLY SIRONA BECAME AWARE OF A MALFUNCTION FOR SAME/SIMILAR DEVICES THAT COULD HAVE POSSIBLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. PRODUCTS RETURN IS REQUESTED AND THEY WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED FROM THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE SURGICAL KIT TRAY DISCOLORED AFTER THE FIRST STERILIZATION CYCLE.