RELYX UNICEM 2 CEMENT
Received Aug 18, 2015
Report 9611385-2015-00014 · MDR key 5012227
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, 9611385-2015-00012, AND 9611385-2015-00013, DESCRIBE THE FIRST, SECOND AND THIRD 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 FOR E4D. OTHER 3M ESPE PRODUCTS USED IN THIS TREATMENT MIGHT INCLUDE 3M ESPE RELYX ULTIMATE CEMENT, 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE, 3M ESPE RELYX ULTIMATE CEMENT AND 3M ESPE UNICEM 2 CEMENT. NO OTHER PATIENT INFORMATION WAS MADE AVAILABLE TO 3M ESPE.