RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Sep 25, 2015
Report 9611385-2015-00031 · MDR key 5104647
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
60 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 3005174370-2015-00069 AND 9611385-2015-00032, DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTIVELY.
Description of Event or Problem
ON (B)(6) 2015, A DENTIST REPORTED THAT A (B)(6) FEMALE PATIENT REQUIRES ENDODONTIC TREATMENT OF TOOTH #4. THIS TOOTH HAD A CROWN 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) 2013. THE CROWN DEBONDED ON (B)(6) 2015, AND THE PATIENT REPORTED TEMPERATURE AND PRESSURE SENSITIVITY. THE PATIENT IS SCHEDULED FOR ENDODONTIC TREATMENT ON (B)(6) 2015.