MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-04 for MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA) manufactured by Allesee Orthodontic Appliances.
[2316678]
On (b)(6), 2011, a doctor alleged that upon removal of the mara appliance, a piece of enamel chipped off from the distolingual cusp of a permanent molar tooth of a patient.
Patient Sequence No: 1, Text Type: D, B5
[9491754]
The doctor restored the enamel on the patient's molar tooth without further incident. The doctor was advised on which cements, bands, and crowns to use as well as on removal techniques. To date, the patient is doing fine and will require no further treatment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2011-00010 |
| MDR Report Key | 2356984 |
| Report Source | 05 |
| Date Received | 2011-12-04 |
| Date of Report | 2011-11-08 |
| Date of Event | 2011-11-07 |
| Date Mfgr Received | 2011-11-08 |
| Date Added to Maude | 2011-12-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Street | 13931 SPRING STREET |
| Manufacturer City | STURTEVANT WI 53177 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA) |
| Generic Name | POSITIONER, TOOTH, PREFORMED |
| Product Code | KMY |
| Date Received | 2011-12-04 |
| ID Number | WO3210850 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING STREET STURTEVANT WI 53177 US 53177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2011-12-04 |