RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Aug 18, 2015
Report 9611385-2015-00012 · MDR key 5012027
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT MAY HAVE INVOLVED FOUR MEDICAL DEVICES, FOUR MANUFACTURER REPORTS ARE BEING SUBMITTED. REF MANUFACTURER REPORT NUMBERS 3005174370-2015-00054, 9611385-2015-00013, AND 9611385-2015-00014, DESCRIBE THE FIRST, THIRD AND FOURTH DEVICE, RESPECTFULLY.
Description of Event or Problem
ON (B)(6) 2015, A DENTIST REPORTED THAT ONE OF HIS PATIENTS HAD NEED FOR ENDODONTIC TREATMENT IN TWO TEETH. THE ENDODONTICALLY TREATED TEETH HAD A CROWN AND AN ONLAY MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE. OTHER 3M ESPE PRODUCTS USED IN THIS TREATMENT MIGHT INCLUDE 3M ESPE RELYX ULTIMATE CEMENT, 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE UNICEM 2 CEMENT. NO OTHER PATIENT INFORMATION WAS MADE AVAILABLE TO 3M ESPE.