RELYX ULTIMATE ADHESIVE RESIN CEMENT
Received Aug 6, 2015
Report 9611385-2015-00006 · MDR key 4995015
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Increased Sensitivity
Narrative
Description of Event or Problem
ON (B)(6) 2013, A DENTIST REPORTED THAT SOME OF HIS PTS HAD NEED FOR ENDODONTIC TREATMENT. THESE PTS HAD DENTAL RESTORATIONS MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D, WHICH WERE SEATED WITH 3M ESPE RELX ULTIMATE CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE. THE REPORTING DENTIST INDICATED THAT APPROX 240 OF HIS PTS EXPERIENCED SENSITIVITY. THE DENTIST WAS UNABLE TO PROVIDE A NUMBER FOR THOSE REQUIRING ENDODONTIC TREATMENT BECAUSE THE EVENTS OCCURRED OVER A PERIOD OF SEVERAL YEARS (2011 TO 2015).
Description of Event or Problem
ON (B)(6) 2013, A DENTIST REPORTED THAT SOME OF HIS PTS HAD NEED FOR ENDODONTIC TREATMENT. THESE PTS HAD DENTAL RESTORATIONS MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D, WHICH WERE SEATED WITH 3M ESPE RELX ULTIMATE CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE. THE REPORTING DENTIST INDICATED THAT APPROX 240 OF HIS PTS EXPERIENCED SENSITIVITY. THE DENTIST WAS UNABLE TO PROVIDE A NUMBER FOR THOSE REQUIRING ENDODONTIC TREATMENT BECAUSE THE EVENTS OCCURRED OVER A PERIOD OF SEVERAL YEARS (2011 TO 2015). SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MFR REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE FIRST DEVICE. MFR REPORT NUMBERS (B)(4) AND (B)(4), DESCRIBE THE SECOND AND THIRD DEVICE, RESPECTFULLY.