MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-27 for CARRIERE SLX 713-335-10 manufactured by Ortho Organizers, Inc..
[70972608]
The bracket was removed by the dental hygienist during orthodontic treatment to reposition the bracket to be in a better position for additional alignment. This is the first report of this nature with the carriere slx bracket.
Patient Sequence No: 1, Text Type: N, H10
[70972609]
While removing an orthodontic bracket from the lower right central incisor, the tooth fractured in half through the pulp chamber.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2081322-2017-00001 |
| MDR Report Key | 6437596 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-27 |
| Date of Report | 2017-03-01 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2017-03-01 |
| Date Added to Maude | 2017-03-27 |
| 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 Phone | 7604488600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARRIERE SLX |
| Generic Name | ORTHODONTIC METAL BRACKET |
| Product Code | EJF |
| Date Received | 2017-03-27 |
| Model Number | 713-335-10 |
| Operator | DENTAL HYGIENIST |
| 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 | 3 | 1. Required No Informationntervention | 2017-03-27 |