MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-28 for CARRIERE MOTION 3D COLORS CLASS II 22MM LEFT-SILVER 424-922LN manufactured by Ortho Organizers, Inc.
[131702578]
Device was bonded on (b)(6) 2018. Instructions for debonding the device state that the protocol is to "orient the instrument toward the mesial aspect of the cuspid or bicuspid pad in an occlusal/gingival aspect. Gently squeeze, applying increased coninuous pressure, without any twisting or pulling until the bond fails. " based on the input from the orthodontist's office, the device was removed using the protocol for removing a bracket, which likely would have included twisting and pulling motions.
Patient Sequence No: 1, Text Type: N, H10
[131702579]
While dental hygienist was debonding orthodontic device, patient experienced an enamel fracture of upper left cuspid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2081322-2018-00003 |
| MDR Report Key | 8204894 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-12-11 |
| Date Mfgr Received | 2018-12-17 |
| Date Added to Maude | 2018-12-28 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARRIERE MOTION 3D COLORS CLASS II 22MM LEFT-SILVER |
| Generic Name | METAL ORTHODONTIC BRACKET |
| Product Code | EJF |
| Date Received | 2018-12-28 |
| Model Number | 424-922LN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-12-28 |