MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-27 for ARTGLASS * manufactured by Kulzer.
[206693]
Add'l info rec'd from mfr 7/3/01: mfr notes that the description is incorrect in that artglass is not a "porcelain crown". It is mfr's determination from the info available that the matter described is not reportable. Mfr fully and completely supports their products and is always interested in knowing about anyone encountering any difficulties using artglass materials. If mfr had been made aware of dr's concerns and had been provided with detailed info, mfr would have been able to assist them in using the materials in the prescribed manner.
Patient Sequence No: 1, Text Type: D, B5
[21960003]
This crown material fractures. It does not hold up to forces (normal) applied to teeth. Fractured "porcelain" crowns results in: 1. Danger to pt health as they may swallow parts and/or break other theeth. 2. Medical retreatment of crown subjects pt to the normal risks associated with dental treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021767 |
| MDR Report Key | 330422 |
| Date Received | 2001-04-27 |
| Date Added to Maude | 2001-05-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTGLASS |
| Generic Name | DENTAL CROWN |
| Product Code | ELZ |
| Date Received | 2001-04-27 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 319782 |
| Manufacturer | KULZER |
| Manufacturer Address | 99 BUSINESS PARK DR ARMONK NY 10504 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-04-27 |