MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-13 for DAMON MX manufactured by Ormco Corporation.
[2176826]
On (b)(6), 2011, a doctor reported to ormco corporation that a patient experienced enamel separation upon debonding of the orthodontic bracket.
Patient Sequence No: 1, Text Type: D, B5
[9394505]
A customer complaint was received which alleged that a patient experienced enamel separation during debonding of the orthodontic bracket. The complainant was requested to return the bracket involved in this incident. It is anticipated that an evaluation will be conducted upon receipt of the bracket by ormco. The complainant did not provide any product information, including part numbers or lot numbers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2011-00166 |
| MDR Report Key | 2246420 |
| Report Source | 05 |
| Date Received | 2011-09-13 |
| Date of Report | 2011-08-31 |
| Date of Event | 2011-08-31 |
| Date Mfgr Received | 2011-08-31 |
| Date Added to Maude | 2011-09-13 |
| 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 W COLLINS AVE |
| 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 MX |
| Generic Name | BRACKET, METAL, ORTHODONTIC |
| Product Code | EJF |
| Date Received | 2011-09-13 |
| Operator | OTHER |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-13 |