RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Dec 9, 2015 · Event occurred Sep 22, 2015
Report 9611385-2015-00103 · MDR key 5279643
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
58 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. SECTION OF THIS REPORT DESCRIBES THE SECOND DEVICE. SECTION OF MANUFACTURER REPORT NUMBERS 3005174370-2015-00124 AND 9611385-2015-00104, DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTIVELY.
Description of Event or Problem
ON (B)(6) 2015, A DENTAL PROFESSIONAL INFORMED 3M ABOUT A PATIENT WHO REQUIRED TOOTH EXTRACTION. THIS PATIENT HAD A 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC CROWN SECURED WITH 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE THE PATIENT, A (B)(6) MALE PATIENT, RECEIVED THE LAVA ULTIMATE CROWN ON TOOTH #5 ON (B)(6) 2014. BITEWING X-RAYS TAKEN IN (B)(6) OF 2015 SHOWED NO EVIDENCE OF PROBLEM. ON (B)(6) 2015, THE PATIENT'S CROWN DEBONDED AND THE CROWN WAS RE-CEMENTED BY ANOTHER DENTIST WHO NOTED DECAY. THE PATIENT WAS REFERRED TO A PERIODONTIST WHO WAS UNABLE TO SALVAGE THE REMAINING TOOTH STRUCTURE AND WHO RECOMMENDED EXTRACTION; EXTRACTION WAS PERFORMED ON (B)(6) 2015, AND THE PATIENT IS CURRENTLY REPORTED TO BE HEALING.