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..
[76235682]
The orthodontist removed as much composite as possible around ul3, ul6, ur4 and ur6. Once the excess composite was removed, the dental assistant used a bracket removing plier and squeezed between the bonding pad and tooth. A 1mm of incisal enamel ul3 was fractured. A small amount of flowable composite resin was bonded to the enamel fracture. Because the appliance was bonded to the very incisal edge of the facial surface, the orthodontist thought the enamel may have been too brittle at the edge of the tooth. Additionally, the orthodontist switched the 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
[76235683]
Tooth fracture while debonding carriere motion appliance when removing the carriere from #11 tooth, the mesial edge of the tooth fractured off with the carriere. The patient is symptom free.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2081322-2017-00002 |
| MDR Report Key | 6599788 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-30 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-05-01 |
| 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 920087306 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 920087306 |
| 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 | DENTAL ASSISTANT |
| 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 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-30 |