RELYX ULTIMATE CEMENT
Received Jul 14, 2015 · Event occurred Feb 16, 2015
Report 3005174370-2015-00040 · MDR key 4917854
Device
Product problems
- Loss of or Failure to Bond
Patient
50 YR
- Erosion
- Tissue Damage
- Tissue Breakdown
Narrative
Description of Event or Problem
ON JUNE 17, 2015, 3M ESPE WAS MADE AWARE OF A CASE IN WHICH A PT WITH A 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC WHICH WAS SECURED WITH 3M ESPE RELYX ULTIMATE CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE WAS RECOMMENDED TO HAVE THE TOOTH EXTRACTED, A BONE GRAFT PERFORMED AND AN IMPLANT PLACED. THIS PT HAD THE CROWN PLACED ON TOOTH #30 ON (B)(6) 2013. ON (B)(6) 2014, THE CROWN DEBONDED AND WAS REPLACED (WITH THE SAME THREE 3M ESPE PRODUCTS). ON (B)(6) 2015, THE PT REPORTED TO THE DENTIST THAT THE TOOTH DID NOT FEEL RIGHT AND THAT THE CROWN WAS LOOSE UPON REMOVAL OF THE CROWN, THE DENTIST NOTED A FOUL ODOR. AN X-RAY TAKEN ON THE SAME DAY SHOWED A BREAKDOWN OF THE TOOTH STRUCTURE BETWEEN THE ROOTS. THE TOOTH WAS TEMPORIZED AND THE PT REFERRED TO AN ORAL SURGEON FOR THE EXTRACTION. AT THE TIME OF THIS REPORT, 3M ESPE DOES NOT KNOW IF THE EXTRACTION HAS OCCURRED. SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MFR REPORTS ARE BEING SUBMITTED.
Additional Manufacturer Narrative
MFR REPORT NUMBERS 3005174370-2015-00039 AND 3005174370-2015-00041, DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTFULLY.