RELY ULTIMATE ADHESIVE RESIN CEMENT
Received Oct 1, 2015
Report 9611385-2015-00037 · MDR key 5117011
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
62 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBERS 3005174370-2015-00072 AND 9611385-2015-00038, DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTIVELY.
Description of Event or Problem
ON SEPTEMBER 2, 2015, A DENTIST REPORTED THAT A PATIENT REQUIRED A ROOT CANAL. THIS TOOTH HAD A CROWN MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC WHICH WAS SEATED ON (B)(6) 2014, USING 3M ESPE RELYX ULTIMATE CEMENT AND 3M ESPE UNIVERSAL ADHESIVE. DURING THE WEEK OF (B)(6), 2015, THE PATIENT PRESENTED WITH PAIN AND UPON REMOVAL OF THE CROWN, RECURRENT DECAY TOO EXTENSIVE TO ALLOW FOR RESTORATION WAS NOTED AND THE PATIENT WAS REFERRED FOR ENDODONTIC TREATMENT.