MalfunctionELM
MONDIAL 6
Received Oct 30, 2013
Report 3006610834-2013-00017 · MDR key 3450003
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 ARE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. COMPLAINT RATE FOR THIS MALFUNCTION IS LESS THAN (B)(4). THE COMPLAINT RATE IS VERY LOW AND WITHIN COMPLIANCE RANGE. THE COMPLAINT RATE WILL CONTINUED TO BE MONITORED. DUE TO THE AFOREMENTIONED REASON, CAPA MEASURES ARE NOT RECOMMENDED. THE LAB DESTROYED THE REMAINING PORTION OF THE TOOTH TO REMOVE AND DID NOT HAVE KNOWLEDGE OF THE BROKEN PORTION'S LOCATION.
Remedial action
- Replace