RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Jul 24, 2015
Report 3005174370-2015-00043 · MDR key 4945031
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Sensitivity of Teeth
Narrative
Description of Event or Problem
ON (B)(6) 2015, A DENTAL PROFESSIONAL REPORTED TO 3M ESPE THAT SOME OF HIS PATIENTS REQUIRED ENDODONTIC TREATMENT TO RELIEVE PERSISTENT SENSITIVITY EXPERIENCED AFTER PLACEMENT OF 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D. THE DENTIST WAS UNABLE TO PROVIDE ANY FURTHER DETAIL ON THE NUMBER OF PATIENTS INVOLVED OR THE DATES ON WHICH THESE ENDODONTIC TREATMENTS WERE PERFORMED. COMPANION PRODUCTS USED TO SECURE THE CROWNS WERE 3M ESPE RELYX ULTIMATE CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE, AS WELL AS OTHER NON-3M ESPE CEMENTS. SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MFR REPORTS ARE BEING SUBMITTED.
Additional Manufacturer Narrative
3M ESPE REC'D THIS REPORT ON JUNE 24, 2015, AND HAS ATTEMPTED TO OBTAIN MORE SPECIFIC INFORMATION. HOWEVER, BECAUSE THE REPORTED EVENTS HAPPENED SOMETIME BETWEEN 2011 AND 2015 AND BECAUSE THE DENTIST WAS NOT WILLING OR ABLE TO PROVIDE ADDITIONAL INFORMATION, PATIENT-SPECIFIC REPORTING IS NOT POSSIBLE. MFR REPORT NUMBERS 3005174370-2015-00042 AND 3005174370-2015-00044, DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTFULLY.