RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Oct 30, 2015 · Event occurred Mar 6, 2013
Report 9611385-2015-00055 · MDR key 5193114
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
49 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 ROOT CANAL TREATMENT. SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBERS 3005174370-2015-00093 AND 9611385-2015-00056 DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTIVELY.
Description of Event or Problem
ON SEPTEMBER 25, 2015, A REPRESENTATIVE FROM A DENTAL OFFICE REPORTED THAT PATIENTS WITH 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE CROWNS REQUIRED ROOT CANAL TREATMENT. FOLLOW-UP INFORMATION PROVIDED BY THE OFFICE ON OCTOBER 7, 2015, DETAILED THE CASE OF A (B)(6) YEAR OLD FEMALE PATIENT WHO RECEIVED A LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC CROWN ON TOOTH #3 SECURED WITH 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT ON (B)(6) 2013. THE PATIENT EXPERIENCED PAIN UPON BITING AND TO TEMPERATURE (ONSET DATE OF SYMPTOMS WAS NOT PROVIDED) AND ON (B)(6) 2013, A ROOT CANAL WAS PERFORMED. THE PATIENT IS CURRENTLY REPORTED TO BE ASYMPTOMATIC.