MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-05 for CARRIERE MOTION CLASS II 17MM RIGHT 424-917RN manufactured by Ortho Organizers, Inc.
[84945430]
Instructions for use and quick start guide both specifically state that the cuspid or bicuspid pad is to be debonded first, followed by debonding the molar pad. In this instance, the device was removed by debonding the molar pad first, then attempting to debond the bicuspid pad.
Patient Sequence No: 1, Text Type: N, H10
[84945511]
While the technician was removing carriere motion class ii 17 mm right device, maxillary 1st bicuspid fractured. In addition the tooth fracturing, the pliers that were being used were broken during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2081322-2017-00004 |
| MDR Report Key | 6843863 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-05 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-08-17 |
| Date Mfgr Received | 2017-08-17 |
| Date Added to Maude | 2017-09-05 |
| 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 17MM RIGHT |
| Generic Name | BRACKET, METAL, ORTHODONTIC |
| Product Code | EJF |
| Date Received | 2017-09-05 |
| Returned To Mfg | 2017-08-23 |
| Model Number | 424-917RN |
| Operator | DENTAL ASSISTANT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-09-05 |