MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-27 for BRUXZIR BLOCK manufactured by Prismatik Dentalcraft, Inc..
[17577972]
"alleged allergic reaction". Patient wanted two bruxzir crowns to replace gold crowns. Dr. (b)(6) had them made and cemented into patient's mouth. Patient read that bruxzir crowns are finished with a spray glaze that has aluminum oxide as a component. Patient reported to dr. (b)(6) laboratories that he now has vomiting, diarrhea, and stomach cramps from the aluminum in the spray glaze. Patient had another dentist remove the bruxzir crowns and had e. Max crowns put in. E. Max is very similar to bruxzir and is also finished with their ceram spray glaze which also has aluminum oxide as a component. Aluminum oxide is a ceramic not a metal. Metal allergies present with rash and swelling, patient has neither.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002195199-2014-00061 |
| MDR Report Key | 4043055 |
| Report Source | 05 |
| Date Received | 2014-08-27 |
| Date of Report | 2014-08-12 |
| Date Mfgr Received | 2014-08-12 |
| Date Added to Maude | 2014-08-28 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. KATHLEEN DRAGOVICH |
| Manufacturer Street | 2212 DUPONT DRIVE |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal | 92612 |
| Manufacturer Phone | 9493991940 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Street | 18561 VON KARMAN |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRUXZIR BLOCK |
| Generic Name | PORCELAIN POWDER |
| Product Code | EIH |
| Date Received | 2014-08-27 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Address | 2212 DUPONT DRIVE IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-27 |