3M ESPE RELYX ULTIMATE
Received Dec 21, 2016 · Event occurred Nov 17, 2016
Report 9611385-2016-00015 · MDR key 6196864
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
37 YR
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
THIS EVENT INVOLVED TWO MEDICAL DEVICES, THEREFORE TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBER 9611385-2016-00014 DESCRIBES THE FIRST DEVICE.
Description of Event or Problem
ON NOVEMBER 25, 2016 IT WAS REPORTED TO 3M (B)(4) THAT AFTER A DENTAL TREATMENT ON (B)(6) 2016 WITH OUR PRODUCTS 3M ESPE SCOTCHBOND UNIVERSAL AND 3M ESPE RELYX ULTIMATE A PATIENT STARTED TO SUFFER FROM PULPITIC PAIN. SUBSEQUENTLY A ROOT CHANNEL TREATMENT WAS PERFORMED ON (B)(6) 2016. CURRENTLY THE PATIENT IS DOING FINE. A FOLLOW-UP INTERVIEW WITH THE DENTIST SHOWED, THAT THE CROWN WAS ATTACHED BEFORE WITH A HARVARD CEMENT FROM A COMPETITOR, BUT HAD TO BE REMOVED BECAUSE OF DECEMENTATION. THE CROWN WAS THEN ATTACHED WITH 3M ESPE SCOTCHBOND UNIVERSAL AND 3M ESPE RELYX ULTIMATE. THE REASON FOR THE ADVERSE EVENT IS HIGHLY PROBABLY A PULPITIC INFECTION CAUSED BY LEAKAGE AFTER THE DEBONDING OF THE CROWN.