inforMED
MalfunctionELM

MONDIAL 8 (DEVICE 2)

Received Sep 26, 2013

Report 1925223-2013-00141 · MDR key 3451502

Device

Generic name

Elm Denture, Plastic, Teeth

Model number

A1 / 33L

Catalog number

66017296

Product problems

  • Material Separation

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THIS IS THE SECOND OF TWO REPORTS ON TWO SEPARATE DEVICES FOR ONE INCIDENT. (B)(6) 2013 - THE DENTIST CALLED BECAUSE HE HAD A VERY UPSET PT THAT HAD JUST RECEIVED HER IMPLANT RETAINED BRIDGE ONE MONTH AGO AND THREE OF THE TEETH BROKE. HE SAID THAT TEETH 21, 22, AND 23 BROKE. HE HAS THE PIECES AND NEEDS IMMEDIATE REPLACEMENT. HE SAID THAT THE PT IS UPSET BUT OTHERWISE FINE. (B)(6) 2013 - SPOKE TO LAB TECHNICIAN. HE SAID THAT HE HAS MADE MANY ALL ON 4 IMPLANTS AND DENTURES USING MONDIAL AND NEVER HAD THIS BEFORE. HE SAID THAT THIS WAS THE FULL MOUTH FIXED ALL ON 4 STYLE IMPLANT. HE SAID IT IS PROBABLY THE PT'S INABILITY TO FEEL THAT CAUSED THE BREAKAGE ISSUE. MFR REF # 3006610834-2013-00016.