MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-20 for DAMON CLEAR manufactured by Ormco Corporation.
[18202981]
The patient's tooth was repaired and a new damon clear bracket was placed. The patient is doing fine. The doctor stated that the bracket was placed in the middle of the tooth and an etm bracket removal plier, and not a damon clear debonding instrument as recommended in the damon clear debonding protocol, was used to debond the bracket. It can therefore be concluded that user error contributed to this incident. No product was returned for evaluation and no part number or lot number were provided therefore no further investigation can take place.
Patient Sequence No: 1, Text Type: N, H10
[18373520]
On (b)(6), 2011, a doctor reported to ormco corporation that a patient experienced enamel loss upon debonding a damon clear bracket.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2011-00093 |
| MDR Report Key | 2098193 |
| Report Source | 05 |
| Date Received | 2011-05-20 |
| Date of Report | 2011-04-25 |
| Date Mfgr Received | 2011-04-25 |
| Date Added to Maude | 2011-05-24 |
| 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 CLEAR |
| Generic Name | ORTHODONTIC PLASTIC BRACKET |
| Product Code | NJM |
| Date Received | 2011-05-20 |
| 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 HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-20 |