FDA Adverse Event
Injury
Summary report: N
HERBST
MDR report key: 3902645
·
Received June 30, 2014
Report
- Report Number
- 2184045-2014-00001
- Event Type
- Injury
- Date Received
- June 30, 2014
- Report Date
- June 6, 2014
- Manufacturer
- ALLESEE ORTHODONTIC APPLIANCES
- Product Code
- EJF
- PMA / PMN Number
- K923405
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT WAS REFERRED TO A DENTIST WHERE HE RECEIVED DENTAL REPAIR. TO DATE, THE PATIENT HAS FULLY RECOVERED AND IS DOING FINE. A VISUAL AND PHYSICAL INSPECTION OF THE APPLIANCE REVEALED THAT THE LINGUAL ARCH WIRE HAD BROKEN JUST MESIAL TO SOLDER TO CROWN. A NEW APPLIANCE WAS FABRICATED WITH CONSIDERATION TO THE PATIENT COMFORT.
Description of Event or Problem · 1
A DOCTOR ALLEGED THAT A PATIENT HAD BROKEN A LOWER MOLAR WHILE WEARING A HERBST APPLIANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380086 | HERBST | BITE-JUMPING ORTHODONTIC APPLIANCE | EJF | ALLESEE ORTHODONTIC APPLIANCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |