3M ESPE RELYX ULTIMATE ADHESIVE CEMENT
Received Apr 3, 2015
Report 3005174370-2015-00022 · MDR key 4660186
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Sensitivity of Teeth
Narrative
Additional Manufacturer Narrative
THERE WERE THREE DEVICES INVOLVED IN THIS EVENT. THIS REPORT DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBERS 3005174370-2015-00021 AND 3005174370-2015-00023 PROVIDE INFORMATION ON THE FIRST AND THIRD DEVICE INVOLVED IN THIS EVENT, RESPECTFULLY.
Description of Event or Problem
DENTIST REPORTED THAT FOLLOWING THE USE OF 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC, 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE TO PREPARE AND SEAT FULL COVERAGE CROWNS, 5-6 PATIENTS REQUIRED ENDODONTIC TREATMENT DUE TO PERSISTENT SENSITIVITY. FOLLOWING THE ROOT CANAL IN ALL OF THESE CASES, THE PATIENTS ARE REPORTED AS FINE; NON-3M ESPE PRODUCTS WERE USED IN THE REPLACEMENT PROCEDURE. NO FURTHER DETAILS ON THE PATIENTS OR TEETH INVOLVED WERE MADE AVAILABLE TO 3M ESPE.