MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-23 for DAMON 3MX 494-4451 manufactured by Ormco Corp..
[710512]
In 2007, the doctor who initially placed the appliance on the patient's tooth reported to corporation that his patient came into the office with a bracket that was accidentally debonded and had fallen off. The bracket contained a small piece of the patient's tooth enamel, which had apparently broken off when the bracket debonded. The patient experienced enamel damage at the site of debonding in the form of a small hole about 1-1 1/2mm thick on the lower right tooth number 5.
Patient Sequence No: 1, Text Type: D, B5
[7857830]
The doctor who placed the bracket took the patient to a dentist to examine the damaged tooth. The dentist restored the tooth with a composite material and confirmed that the tooth would be fine and that it did not require a root canal. The doctor believes that the patient's tooth may have already been compromised prior to receiving treatment with orthodontic brackets, which may have contributed to the event. He reported that this is a highly unusual event that has never occurred with any of the over 300 patients he treats. However, the doctor has experienced more loose brackets with this particular patient than any other patient he has treated, and he has had to lecture the patient on several occasions on the proper care during orthodontic treatment. See scanned pages
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2007-00043 |
| MDR Report Key | 901319 |
| Report Source | 05 |
| Date Received | 2007-08-23 |
| Date of Report | 2007-07-26 |
| Date of Event | 2007-07-01 |
| Date Mfgr Received | 2007-07-26 |
| Date Added to Maude | 2007-08-30 |
| 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 | 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 CORP. |
| 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 | DYH |
| Date Received | 2007-08-23 |
| Returned To Mfg | 2007-07-30 |
| Catalog Number | 494-4451 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 879131 |
| Manufacturer | ORMCO CORP. |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-08-23 |