RELYX ULTIMATE CEMENT
Received Apr 3, 2015
Report 3005174370-2015-00025 · MDR key 4660174
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
DENTIST REPORTED THAT FOLLOWING THE USE OF 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE, 3M ESPE RELYX, ULTIMATE ADHESIVE RESIN CEMENT AND (B)(6) ADHESIVE TO PREPARE AND SEAT FULL COVERAGE CROWNS, A PATIENT REQUIRED EXTRACTION OF THE TREATED TOOTH BECAUSE OF AN INFECTION IN THE ROOT CANALS. FOLLOWING THE EXTRACTION AND REPLACEMENT WITH AN IMPLANT AND CROWN, THE SYMPTOMS RESOLVED. NO 3M ESPE PRODUCTS WERE USED IN THE REPLACEMENT PROCEDURE. THE DENTIST DOES NOT RECALL SPECIFICALLY WHAT TOOTH WAS INVOLVED IN THIS CASE; IT MAY HAVE BEEN TOOTH 14 OR 15.
Additional Manufacturer Narrative
THERE WERE THREE DEVICES INVOLVED IN THIS EVENT. MANUFACTURER REPORT NUMBERS 3005174370-2015-00024 AND 3005174370-2015-00026 PROVIDE INFORMATION ON THE FIRST AND THIRD DEVICE INVOLVED IN THIS EVENT, RESPECTFULLY.