MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-26 for CARRIERE MOTION 3D COLORS CLASS II 25MM LEFT - SILVER 424-925LN manufactured by Ortho Organizers, Inc.
[125158767]
Instructions for use (ins 181a rev c) and quick start guide (999-329 rev a) both specifically state in step 4 of removal process: take one of the recommended removal instruments and place the tip ends at the adhesive interface (concave channel) between the motion 3d appliance cuspid pad and the tooth surface. Orient the instrument toward the mesial aspect of the cuspid or bicuspid pad in an occlusal/gingival aspect. Gently squeeze, applying increased continuous pressure, without any twisting or pulling until the bond fails. In this instance, the dentist stated that the sides of the pad of the device was used. In addition, examination of the returned product has evidence of tool marks on the product, not on the adhesive interface.
Patient Sequence No: 1, Text Type: N, H10
[125158768]
While the technician was removing carriere motion 3d colors class ii 25mm left - silver, upper left 3 canine fractured. Per the dentist, the following steps were taken: removal of excess adhesive with high speed hand piece; having patient bite on cotton roll; squeezing on each side of pad with bracket removing plier. Device was bonded on (b)(6) 2018 and was being debonded due to the patient being finished with the treatment step.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2081322-2018-00001 |
| MDR Report Key | 8009692 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-26 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-10-02 |
| Date Mfgr Received | 2018-10-08 |
| Date Added to Maude | 2018-10-26 |
| 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 3D COLORS CLASS II 25MM LEFT - SILVER |
| Generic Name | DISTALIZER |
| Product Code | EJF |
| Date Received | 2018-10-26 |
| Returned To Mfg | 2018-10-18 |
| Model Number | 424-925LN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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. Deathisabilit | 2018-10-26 |