MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-31 for DAMON 3MX 494-4491 manufactured by Ormco Corporation.
[9582517]
The device involved in the alleged incident was returned and evaluated. The returned bracket revealed that the top of the tie-wing had a deep gouge, which may be the result of an improper debonding technique. One edge of the debonding plier made contact with the tie wing component instead of the bracket base during the debonding. This improper technique would most likely lead to enamel damage because the pad is not forced to flex. The bracket was most likely twisted or torqued off, which would lead to the enamel fracturing. These investigation results indicate that a user/technique related error contributed to this incident and that it was not due to a product failure or malfunction.
Patient Sequence No: 1, Text Type: N, H10
[16126958]
On (b)(6) 2011, a doctor reported to ormco corporation that multiple patients experienced enamel separation upon debonding of the orthodontic bracket.
Patient Sequence No: 1, Text Type: D, B5
[16332969]
A customer complaint was received which alleged that multiple patients experienced enamel separation during debonding of the orthodontic bracket. The doctor was not definitive as to the exact number of patients involved. Confirmed with the doctor's office that all patients are doing fine and the enamel was repaired on all patients. In the complaint, five different products were identified. This mdr is on one of the five devices.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2011-00161 |
| MDR Report Key | 2229887 |
| Report Source | 05 |
| Date Received | 2011-08-31 |
| Date of Report | 2011-08-01 |
| Date Mfgr Received | 2011-08-01 |
| Date Added to Maude | 2011-09-01 |
| 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 3MX |
| Generic Name | BRACKET, METAL, ORTHODONTIC |
| Product Code | EJF |
| Date Received | 2011-08-31 |
| Catalog Number | 494-4491 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-08-31 |