FDA Adverse Event
Malfunction
Summary report: N
DIAZIR
MDR report key: 6056906
·
Received October 26, 2016
Report
- Report Number
- 3008780085-2016-00001
- Event Type
- Malfunction
- Date Received
- October 26, 2016
- Report Date
- October 20, 2016
- Manufacturer
- ARDENT, INC
- Product Code
- EIH
- PMA / PMN Number
- K070699
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER CLAIMS A STRUCTURE BROKE WHILE IN THE MOUTH. THE STRUCTURE WAS PRODUCED IN DIAZIR IN ANATOMICAL REDUCED FORMS AND SUBSEQUENTLY COMPLETED IN CERAMIC. THE WORK WAS MILLED IN (B)(6) 2012. THE ANALYZED STRUCTURE WAS FIXED IN THE MOUTH USING TEMPORARY CEMENT FOR 4 YEARS. THE GUARANTEE, SO THAT IT CAN BE VALID ON A CASE IN THE MOUTH BREAK, APPLIES ONLY IF THE TREATMENT IS TO BE SECURED WITH PERMANENT CEMENTATION. TEMPORARY CEMENTS ARE INTENDED FOR TEMPORARY NOT PERMANENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 709799 | DIAZIR | POWDER, PORCELAIN | EIH | ARDENT, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |