RELYX ULTIMATE ADHESIVE RESIN CEMENT

Additional Manufacturer Narrative

THIS REPORT DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBERS 3005174370-2015-00049 AND 9611385-2015-00011, DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTFULLY.

Description of Event or Problem

A DENTIST REPORTED THAT ONE OF HER PATIENTS REQUIRED EXTRACTION OF TOOTH #29. THIS PATIENT HAD A CROWN PLACED ON (B)(6) 2014, MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC, WHICH WAS SEATED WITH 3M ESPE RELYX ULTIMATE CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE. ON (B)(6) 2015, IT WAS NOTED THAT LEAKAGE HAD OCCURRED RESULTING IN SECONDARY CARIES; BECAUSE THE TOOTH HAD RECEIVED ENDODONTIC TREATMENT IN THE PAST (DETAILS NOT PROVIDED TO 3M ESPE), THE CARIES PROGRESSED UNDETECTED TO A POINT WHERE EXTRACTION WAS THE ONLY TREATMENT OPTION. THE PATIENT WILL RECEIVE AN IMPLANT.

Additional Manufacturer Narrative

SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE THIRD DEVICE. MANUFACTURER REPORT NUMBERS 3005174370-2015-00049 AND 9611385-2015-00010, DESCRIBE THE FIRST AND SECOND DEVICE, RESPECTFULLY.

Description of Event or Problem

A DENTIST REPORTED THAT ONE OF HER PATIENTS REQUIRED EXTRACTION OF TOOTH #29. THIS PATIENT HAD A CROWN PLACED ON (B)(6) 2014, MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D, WHICH WAS SEATED WITH 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX ULTIMATE CEMENT. ON (B)(6) 2015, IT WAS NOTED THAT LEAKAGE HAD OCCURRED RESULTING IN SECONDARY CARIES; BECAUSE THE TOOTH HAD REC'D ENDODONTIC TREATMENT IN THE PAST (DETAILS NOT PROVIDED TO 3M ESPE), THE CARIES PROGRESSED UNDETECTED TO A POINT WHERE EXTRACTION WAS THE ONLY TREATMENT OPTION. THE PATIENT WILL RECEIVE AN IMPLANT.