MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-20 for DAMON CLEAR 497-6471 manufactured by Ormco Corporation.
[1811774]
On october 20, 2010, 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
[8899094]
The doctor's office reported that the debonding of a damon clear bracket caused enamel delamination when a doctor removed it for repositioning. The tooth was repaired and re-prepped and a new damon clear bracket was bonded. The patient is doing fine. The doctor stated that when the bracket was initially placed, he applied ortho solo plus to both the tooth and the bracket. This goes against the instructions for use for ortho solo plus which states that it should be applied to only the tooth, as applying excess primer beyond the instructed usage will increase bond strength and could subsequently result in enamel damage upon debonding. A visual inspection of the returned bracket indicated that an excess amount of adhesive was applied which also increases bonding forces and can also result in enamel damage upon debonding. The visual inspection also indicated that the bracket was placed very close to the gingiva. The location of the bracket may have limited the access of the debonding instrument, resulting in poor positioning of the debonding tool and subsequent enamel damage. The results of the investigation indicate that the cause for the enamel damage was due user error and not to a product failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2010-00189 |
| MDR Report Key | 1903937 |
| Report Source | 05 |
| Date Received | 2010-11-20 |
| Date of Report | 2010-10-20 |
| Date Mfgr Received | 2010-10-20 |
| Date Added to Maude | 2010-11-22 |
| 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 | 2010-11-20 |
| Catalog Number | 497-6471 |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2010-11-20 |