RELYX UNICEM 2 CEMENT
Received Nov 2, 2015 · Event occurred Aug 25, 2015
Report 9611385-2015-00059 · MDR key 5196454
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
43 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
ADDITIONAL REPORTS WILL BE MADE FOR THE OTHER PATIENTS WITH LAVA ULTIMATE CROWNS IN THIS PRACTICE WHO REQUIRED TOOTH EXTRACTION. SINCE THIS EVENT INVOLVED FOUR MEDICAL DEVICES, FOUR MANUFACTURER REPORTS ARE BEING SUBMITTED. SUSPECT MEDICAL DEVICE SECTION OF THIS REPORT DESCRIBES THE SECOND DEVICE. SUSPECT MEDICAL DEVICE SECTION OF MANUFACTURER REPORT NUMBERS 3005174370-2015-00095, 9611385-2015-00060 AND 9611385-2015-00061, DESCRIBE THE FIRST, THIRD AND FOURTH DEVICE, RESPECTIVELY.
Description of Event or Problem
ON (B)(6) 2015, A REPRESENTATIVE FROM A DENTAL OFFICE REPORTED THAT PATIENTS WITH 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE CROWNS REQUIRED TOOTH EXTRACTION. FOLLOW-UP INFORMATION PROVIDED BY THE OFFICE ON (B)(6) 2015, DETAILED THE CASE OF A (B)(6) FEMALE PATIENT WHO RECEIVED A LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC CROWN ON TOOTH #30 SECURED WITH 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE, 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT AND 3M ESPE RELYX UNICEM 2 CEMENT ON (B)(6) 2012. NO INFORMATION WAS PROVIDED TO INDICATE HOW THE DECAY UNDER THE CROWN WAS IDENTIFIED; THE OFFICE NOTES THAT THE DECAY WAS TO AN EXTENT THAT THE TOOTH WAS NOT SALVAGEABLE. THE TOOTH WAS EXTRACTED ON (B)(6) 2015.