MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-26 for DIAZIR 636427 manufactured by Ardent, Inc.
[58850004]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008780085-2016-00001 |
| MDR Report Key | 6056906 |
| Date Received | 2016-10-26 |
| Date of Report | 2016-10-20 |
| Date Mfgr Received | 2016-07-01 |
| Date Added to Maude | 2016-10-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS DONNA HARTNETT |
| Manufacturer Street | 175 PINEVIEW DRIVE |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166912260 |
| Manufacturer G1 | ARDENT, INC. |
| Manufacturer Street | 175 PINEVIEW DRIVE |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14228 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIAZIR |
| Generic Name | POWDER, PORCELAIN |
| Product Code | EIH |
| Date Received | 2016-10-26 |
| Catalog Number | 636427 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARDENT, INC |
| Manufacturer Address | 175 PINEVIEW DR AMHERST NY 14228 US 14228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-26 |