inforMED
MalfunctionELM

MONDIAL 6

Received Oct 30, 2013

Report 1925223-2013-00155 · MDR key 3450023

Device

Generic name

Elm Denture, Plastic, Teeth

Model number

BL2 / L315

Catalog number

66801038

Product problems

  • Material Separation

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

LAB REP CALLED AND SAID THAT THE COMPLETE REMOVABLE DENTURE WAS DELIVERED ON (B)(6) 2012. SHE SAID THAT IT WAS A LOWER ANTERIOR TOOTH. SHE DID NOT KNOW WHICH TOOTH, MOLD OR SHADE IT WAS, BUT SAID SHE WOULD ASK THE LAB GUYS. SHE SAID THAT SHE DOES NOT THINK THE PT SWALLOWED ANY OF THE TOOTH AND WOULD CHECK TO SEE IF THEY HAVE THE FRAGMENTS. SHE SAID THE PT WAS VERY ANGRY THAT SHE HAD TO PAY FOR THE REPAIR. SHE SAID THAT THEY BELIEVE THE PT WAS EATING AND BIT INTO SOMETHING VERY HARD. SHE DID NOT KNOW THE PT'S AGE. ON (B)(6) 2013 LAB REP CALLED AND GAVE THE MOULD AND SHADE. SHE SAID THAT TOOTH NUMBER 24 BROKE. THEY DO NOT HAVE THE BROKEN OFF PART AND THE PART THAT REMAINED IN THE DENTURE WAS DESTROYED TO REMOVE. REF MFR 3006610834-2013-00017.