MalfunctionELM
MONDIAL 8 (DEVICE 2)
Received Sep 26, 2013
Report 3006610834-2013-00016 · MDR key 3451470
Device
Generic name
Elm Denture, Plastic, Teeth
Manufacturer
Heraeus Kulzer GmbhProduct problems
- Material Separation
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
(B)(4).
Additional Manufacturer Narrative
(B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. RESULTS: ONLY BROKEN OFF PORTION OF DENTURE TOOTH RETURNED. THE PORTION OF DENTURE TOOTH THAT REMAINED IN THE ALL-ON-FOUR WAS NOT RETURNED AS THE REMOVAL PROCESS REQUIRES THAT IT BE GROUND OUT OF THE ACRYLIC. THEREFORE NOTHING REMAINED TO RETURN.
Remedial action
- Replace