D
Patient 1
A DOCTOR'S OFFICE ALLEGED THAT WHILE REMOVING THE HERBST APPLIANCE A PATIENT HAD EXPERIENCED THE LOSS OF A CROWN, WHICH HAD ATTACHED TO IT AN AMALGAM RESTORATION AND SOME OF THE PATIENT'S NATURAL DENTITION.
MAUDE MDR 3093893
- MDR report key
- 3093893
- Report number
- 2184045-2013-00005
- Event key
- 0
- Event type
- 3
- Date received
- 2013-05-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MRS. KERRI CASINO
- Address
- 1717 W COLLINS AVE ORANGE CA 92867 US
- Phone
- 714-714-7145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HERBST | BITE-JUMPING ORTHODONTIC APPLIANCE | ALLESEE ORTHODONTIC APPLIANCES | EJF | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-05-06 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
A NEW CROWN WAS PLACED FOR THE PATIENT BY A DENTIST, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE AND HAS FULLY RECOVERED. A NEW APPLIANCE WILL BE FABRICATED WITH CONSIDERATION TO PATIENT COMFORT. A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE, YIELDING RESULTS WITHIN SPECIFICATIONS.