3M ESPE RELYX ULTIMATE AUTOMAX CEMENT
Received Jan 27, 2015
Report 3005174370-2015-00009 · MDR key 4459574
Device
Product problems
- Patient-Device Incompatibility
Patient
50 YR
- Sensitivity of Teeth
Narrative
Description of Event or Problem
ON (B)(6) 2014, A DEALER REPRESENTATIVE INFORMED 3M ESPE THAT A DENTAL PROFESSIONAL WHO USED 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D, 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX ULTIMATE CEMENT HAD A MALE PATIENT WHO ULTIMATELY REQUIRED ENDODONTIC TREATMENT. UPON FOLLOW-UP DIRECTLY WITH THE DENTAL PROFESSIONAL, IT WAS LEARNED THAT THE PATIENT EXPERIENCED RECURRENT SENSITIVITY THAT RESULTED IN THE NEED FOR A ROOT CANAL.
Additional Manufacturer Narrative
THERE WERE THREE SUSPECT DEVICES INVOLVED IN THIS EVENT. MANUFACTURER REPORT NUMBERS 3005174370-2015-00007 AND 3005174370-2015-00008 PROVIDE INFORMATION ON THE FIRST AND SECOND SUSPECT DEVICES INVOLVED IN THIS EVENT, RESPECTIVELY.