MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-01 for DAMON CLEAR 497-6472 manufactured by Ormco Corporation.
[19996784]
A doctor alleged that a patient experienced enamel fracture of her #7 tooth, upon the debonding of the upper right damon clear bracket.
Patient Sequence No: 1, Text Type: D, B5
[20279352]
It was confirmed by the doctor that the rest of the patient's upper right brackets were removed without incident; the doctor removed the other remaining brackets with a diamond bur. The patient was sent to her dentist the same day; root canal treatment was performed on her #7 tooth by the doctor and a temporary restoration was placed. The permanent crown was placed on (b)(6) 2012. To date, the patient is doing fine and has not encountered any problems with regard to her crown. The device involved in the alleged incident will not be returned by the doctor and no lot number was provided; therefore, no investigation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2012-00016 |
| MDR Report Key | 2555533 |
| Report Source | 05 |
| Date Received | 2012-05-01 |
| Date of Report | 2012-04-02 |
| Date of Event | 2012-04-02 |
| Date Mfgr Received | 2012-04-02 |
| Date Added to Maude | 2012-05-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAMON CLEAR |
| Generic Name | CERAMIC ORTHODONTIC BRACKET |
| Product Code | NJM |
| Date Received | 2012-05-01 |
| Catalog Number | 497-6472 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILLS AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-05-01 |