MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-09-05 for ALLURE UNK manufactured by Gac.
[330673]
The dr reported fracturing the enamel of a pt's tooth during the debonding of an allure orthodontic bracket. The pt was referred to a general dentist for root canal therapy and rebonding of the enamel. The dr reported using reybond with flouride for cementation and a unitek plier for removing the bracket, neither of which are dentsply products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2418500-2003-00106 |
| MDR Report Key | 481870 |
| Report Source | 05 |
| Date Received | 2003-09-05 |
| Date of Report | 2003-07-11 |
| Date of Event | 2003-06-01 |
| Date Mfgr Received | 2003-07-11 |
| Date Added to Maude | 2003-09-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | 570 W COLLEGE AVE |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY GAC INTERNATIONAL |
| Manufacturer Street | 355 KNICKERBOCKER AVE |
| Manufacturer City | BOHEMIA NY 11716310 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11716 3103 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLURE |
| Generic Name | ORTHODONTIC BRACKET |
| Product Code | DYW |
| Date Received | 2003-09-05 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 470756 |
| Manufacturer | GAC |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-09-05 |