MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-19 for CARRIERE MOTION CLASS II 424-925LN manufactured by Ortho Organizers, Inc..
[49945310]
Tooth fracture can occur upon debonding (removal) of device. Literature describing debonding adverse events can be traced back to at least 1996. This was a new user of the device. Literature accompanying device specifically states the instruments to use, and that debonding is conducted without twisting or pulling. Providers are trained to use care when debonding device. Provider re-trained on debonding protocol and provided with appropriate instruments to use for debonding.
Patient Sequence No: 1, Text Type: N, H10
[49945311]
Patient was in to have device removed after 4 months of use. Provider removed excess adhesive from around device. With a pair of 'regular' pliers, applied twisting motion to deform and debond the device. Device debonded from surface and patch of enamel broke off and remained attached to the device.
Patient Sequence No: 1, Text Type: D, B5
[50646301]
Lot number corrected from 794305 to 794306.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2081322-2016-00001 |
| MDR Report Key | 5806669 |
| Date Received | 2016-07-19 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-06-06 |
| Date Mfgr Received | 2016-06-22 |
| Device Manufacturer Date | 2015-09-02 |
| Date Added to Maude | 2016-07-19 |
| 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 | MS. MARY PEARMAN |
| Manufacturer Street | 1822 ASTON AVE |
| Manufacturer City | CARLSBAD CA 920087306 |
| Manufacturer Country | US |
| Manufacturer Postal | 920087306 |
| Manufacturer Phone | 7604488600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARRIERE MOTION CLASS II |
| Generic Name | CARRIERE MOTION CLASS II |
| Product Code | EJF |
| Date Received | 2016-07-19 |
| Model Number | 424-925LN |
| Lot Number | 794306 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO ORGANIZERS, INC. |
| Manufacturer Address | 1822 ASTON AVE CARLSBAD CA 920087306 US 920087306 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-19 |