RELYX UNICEM 2 CEMENT
Received Nov 18, 2015 · Event occurred Oct 17, 2012
Report 9611385-2015-00091 · MDR key 5234443
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
44 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. MANUFACTURER REPORT NUMBERS 3005174370-2015-00111 AND 9611385-2015-00092, DESCRIBE THE FIRST AND THIRD 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 FOR CEREC CROWNS REQUIRED ROOT CANAL TREATMENT. FOLLOW-UP INFORMATION PROVIDED BY THE OFFICE ON OCTOBER 7, 2015, DETAILED THE CASE OF A (B)(6) FEMALE PATIENT WHO RECEIVED A LAVA ULTIMATE CROWN ON TOOTH #19 SECURED WITH 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX UNICEM 2 CEMENT ON (B)(6) 2012. THE PATIENT EXPERIENCED PAIN UPON BITING (ONSET DATE OF SYMPTOMS WAS NOT PROVIDED) AND ON (B)(6) 2012, A ROOT CANAL WAS PERFORMED. THE PATIENT IS CURRENTLY REPORTED TO BE ASYMPTOMATIC.