RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Oct 10, 2015 · Event occurred Sep 10, 2015
Report 9611385-2015-00043 · MDR key 5142624
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- 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 3005174370-2015-00076 AND 9611385-2015-00044 DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTIVELY.
Description of Event or Problem
ON (B)(6) 2015, A DENTIST REPORTED THAT A PATIENT WHO HAD A CROWN ON TOOTH #2 MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC REQUIRED EXTRACTION OF THE TREATED TOOTH. ON (B)(6) 2015, THIS PATIENT PRESENTED AT THE OFFICE WITH THE LAVA ULTIMATE CROWN, A POST AND CORE (TOOTH HAD UNDERGONE PRIOR ROOT CANAL TREATMENT). THE LAVA ULTIMATE CROWN HAD BEEN SECURED APPROXIMATELY 1-1/2 TO 2 YEARS PRIOR WITH 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE. THE DENTIST REFUSED TO PULL PATIENT RECORDS TO PROVIDE ADDITIONAL DETAIL, BUT DID STATE THAT WHEN THE PATIENT WAS SEEN 1 YEAR PRIOR TO THE (B)(6) 2015 EVENTS, THERE WAS NO INDICATION THAT THE CROWN WAS LOOSE. THE TOOTH WAS EXTRACTED AND AN IMPLANT PLACED ON (B)(6) 2015.