DRILL STOPPER KIT FOR SEVEN IMPLANT SP

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE BLUE RINGS FALL OFF AFTER STERILIZATION CYCLE.

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. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.