MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-30 for CARRIERE MOTION CLASS II 424-925CN manufactured by Ortho Organizers, Inc.
[76234392]
The orthodontist removed as much composite as possible from around ul3 and ul6 and used a bracket removing plier to squeeze between the pad and tooth. A 1mm divot of enamel was missing from the buccal surface of tooth ul6. The orthodontist bonded a small amount of flowable composite to the fractured enamel. He switched bonding agents approximately 9 months ago due to excessive bond strengths he was experiencing, which may have led to the fractured enamel. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[76234393]
When removing the carriere motion appliance from tooth number 14, a small fracture of enamel broke off with the appliance located on the buccal side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2081322-2017-00003 |
| MDR Report Key | 6599793 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-30 |
| Date of Report | 2017-05-01 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2017-05-01 |
| Date Added to Maude | 2017-05-30 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARY PEARMAN |
| Manufacturer Street | 1822 ASTON AVENUE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer G1 | ORTHO ORGANIZERS, INC. |
| Manufacturer Street | 1822 ASTON AVENUE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARRIERE MOTION CLASS II |
| Generic Name | BRACKET, METAL, ORTHODONTIC |
| Product Code | EJF |
| Date Received | 2017-05-30 |
| Model Number | 424-925CN |
| Operator | DENTIST |
| Device Availability | N |
| 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 920087306 US 920087306 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-30 |