MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-06-07 for HERBST APPLIANCE manufactured by Allesee Orthodontic Appliances.
[670635]
In 5/07, the dr informed allesee orthodontic appliances that the tissue in the pt's mouth had swollen around the cantilever of a previously broken herbst appliance. The dr had to cut a small hole in the pt's crown in order to remove the device for repair.
Patient Sequence No: 1, Text Type: D, B5
[7869633]
The dr repaired the pt's damaged crown. The herbst appliance was repaired and returned to the dr for placement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2007-00002 |
| MDR Report Key | 861549 |
| Report Source | 05 |
| Date Received | 2007-06-07 |
| Date of Report | 2007-05-09 |
| Date of Event | 2007-04-01 |
| Date Mfgr Received | 2007-05-09 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2007-06-15 |
| 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 | 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 ST. |
| 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 | HERBST APPLIANCE |
| Generic Name | BITE-JUMPING ORTHODONTIC APPLIANCE |
| Product Code | DYJ |
| Date Received | 2007-06-07 |
| ID Number | WO#2459398/12-2006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 847047 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING ST. STURTEVANT WI 53177 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-06-07 |