RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Oct 27, 2015 · Event occurred Dec 11, 2014
Report 9611385-2015-00052 · MDR key 5182156
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
45 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL REPORTS WILL BE MADE FOR THE OTHER PATIENTS WITH LAVA ULTIMATE CROWNS IN THIS PRACTICE WHO REQUIRED TOOTH EXTRACTION. 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 3005174370-2015-00091 AND 9611385-2015-00053, DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTIVELY.
Description of Event or Problem
ON (B)(6) 2015, A REPRESENTATIVE FROM A DENTAL OFFICE REPORTED THAT PATIENTS WITH 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC CROWNS REQUIRED TOOTH EXTRACTION. FOLLOW-UP INFORMATION PROVIDED BY THE OFFICE ON (B)(6) 2015, DETAILED THE CASE OF A (B)(6) MALE PATIENT WHO RECEIVED A LAVA ULTIMATE CROWN ON TOOTH #14 SECURED WITH 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT ON (B)(6) 2012. THE PATIENT HAD PREVIOUSLY UNDERGONE ROOT CANAL TREATMENT ON THE TOOTH AND THE LAVA ULTIMATE CROWN FRACTURED REVEALING WHAT WAS DESCRIBED AS RECURRENT DECAY; DATES OF PRIOR ROOT CANAL TREATMENT AND CROWN FRACTURE WERE NOT PROVIDED TO 3M. THE TOOTH WAS EXTRACTED ON (B)(6) 2014.