MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-08-12 for MAESTRO MINI-TWIN BRACKET WITH HOOK 711-399 manufactured by Ortho Organizers, Inc..
[18935014]
On (b)(6) 2013, brackets were placed. Initial diagnosis: class i 18 months, moderate crowding. Tooth #11 perfectly healthy with no signs of previous restorations, decay, or decalcification. Dentist was removing bracket from ul3 (tooth #11) and tooth broke horizontally in half. Post incident diagnosis: #11 horizontal fracture with small pulpal involvement. No signs of decalcification or decay. Clean fracture with bracket still attached to the fractured portion. 2 lugs broken during removal. Tooth #11 will need endo with build up and emax crown at a later date. Tooth was bonded back together and new bracket placed on tooth. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[19134252]
Tooth fracture can occur upon debonding (removal) of bracket. Although most fractures are limited to enamel, the potential for pulpal involvement exists. Literature describing debonding adverse events can be tracked back to at least 1996. Providers are trained to use care when debonding brackets.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2081322-2014-00001 |
| MDR Report Key | 4068001 |
| Report Source | 99 |
| Date Received | 2014-08-12 |
| Date of Report | 2014-08-12 |
| Date of Event | 2014-07-15 |
| Date Mfgr Received | 2014-07-16 |
| Date Added to Maude | 2014-09-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1822 ASTON AVENUE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604488600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAESTRO MINI-TWIN BRACKET WITH HOOK |
| Product Code | EJF |
| Date Received | 2014-08-12 |
| Model Number | 711-399 |
| Catalog Number | 711-399 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO ORGANIZERS, INC. |
| Manufacturer Address | 1822 ASTON AVENUE CARLSBAD CA 92008760 US 92008 7603 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-12 |