D
Patient 1
IN 2007, A PT'S PARENT ALLEGED THAT HALF OF THE PT'S TOOTH BROKE OFF WHEN THE ORTHODONTIST REMOVED THE HERBST APPLIANCE DURING ORTHODONTIC TREATMENT.
MAUDE MDR 931657
- MDR report key
- 931657
- Report number
- 2184045-2007-00003
- Event key
- 0
- Event type
- 3
- Date received
- 2007-10-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- ORLANDO TADEO, JR.
- Address
- 1717 WEST 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 APPLIANCE | BITE-JUMPING ORTHODONTIC APPLIANCE | ALLESEE ORTHODONTIC APPLIANCES | DYJ | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-10-24 | 0 | 1. O |
Event Narratives#
N
Patient 1
THIS ALLEGED INCIDENT AND THE USE OF THE HERBST APPLIANCE COULD NOT BE CONFIRMED. THE COMPLAINANT (THE ALLEGED PT'S MOTHER) WOULD NOT DISCLOSE THE NAME OF THE TREATING ORTHODONTIST TO CONFIRM THE USE OF THE HERBST APPLIANCE. ADDITIONALLY, THE PT COULD NOT BE LOCATED IN ALLESEE ORTHODONTIC APPLIANCE'S PT DATABASE.