3M ESPE RELYX UNICEM 2 AUTOMIX
Received Apr 13, 2016
Report 9611385-2016-00004 · MDR key 5575067
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Missing Value Reason
- Missing Value Reason
Narrative
Additional Manufacturer Narrative
EXACT DATA ON THE SYMPTOMS WHICH LED TO THE NECESSITY OF THE ROOT CANAL TREATMENTS WERE NOT GIVEN BY THE DENTIST. AS DESCRIBED ABOVE IT WAS FOUND OUT THAT A HANDLING ERROR LED TO THE ADVERSE EVENTS. 3M ESPE RELYX UNICEM 2 AUTOMIX HAS BEEN ASSESSED FOR BIOCOMPATIBILITY AND HAS BEEN FOUND TO BE SAFE FOR ITS INTENDED USE. DEVICE WAS NOT SENT TO US.
Description of Event or Problem
ON (B)(6) 2016, A DENTIST REPORTED THAT SEVERAL PATIENT REQUIRED ROOT CANAL TREATMENT AFTER THE USE OF 3M ESPE RELYX UNICEM 2 AUTOMIX. THESE PATIENTS HAD CROWNS MADE FROM THE COMPETITOR MATERIAL E.MAX CAD FROM IVOCLAR VIVADENT. IN AN INTERVIEW WITH THE DENTIST IT SHOWED THAT THERE'S UNDERLYING AN APPLICATION ERROR. THE DENTIST OVERDRIED DURING THE APPLICATION WHICH LED TO PAIN SYMPTOMS AND SUBSEQUENT TO THE ROOT CHANEL TREATMENTS.