RELYX UNICEM 2 CLICKER REFILL
Received Oct 27, 2015 · Event occurred Aug 12, 2013
Report 9611385-2015-00051 · MDR key 5182154
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
57 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 TWO MEDICAL DEVICES, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBER 3005174370-2015-00090 DESCRIBES THE FIRST DEVICE.
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 (B)(6) 2015, DETAILED THE CASE OF A (B)(6) FEMALE PATIENT WHO RECEIVED A LAVA ULTIMATE CROWN ON TOOTH #20 SECURED WITH 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) 2013, A ROOT CANAL WAS PERFORMED. THE PATIENT IS CURRENTLY REPORTED TO BE ASYMPTOMATIC.