FDA Adverse Event
Malfunction
Summary report: N
BRACKET, METAL, ORTHODONTIC
MDR report key: 7102157
·
Received December 8, 2017
Report
- Report Number
- 2016150-2017-00007
- Event Type
- Malfunction
- Date Received
- December 8, 2017
- Report Date
- December 7, 2017
- Manufacturer
- ORMCO CORPORATION
- Product Code
- EJF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
FURTHER INVESTIGATION WAS DONE ON THE INITIAL COMPLAINT AND IN THIS INVESTIGATION THERE WAS NO PATIENT INVOLVED IN THIS ISSUE. FAILURE WAS DETECTED BEFORE THE USAGE OF THE PRODUCT. NO FURTHER EVALUATION CAN CONDUCTED SINCE NO PATIENT WAS INVOLVED WITH THE INCIDENT.
Additional Manufacturer Narrative · 1
IT WAS ALLEGED THAT THE CLEAT (LINGUAL TUBE) WAS FALLING OFF THE BAND. DUE TO THIS A PATIENT SWALLOWED THE CLEAT AND HAD EMERGENCY TREATMENTS; HOWEVER NO FURTHER SPECIFIC INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THIS TIME. ATTEMPTS ARE BEING MADE TO GET FURTHER INFORMATION AND WILL SEND AN UPDATE.
Description of Event or Problem · 1
IT WAS ALLEGED THAT THE CLEAT (LINGUAL TUBE) WAS FALLING OFF THE BAND AND PATIENT SWALLOWED THE CLEAT AND EMERGENCY TREATMENTS WERE DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 881491 | BRACKET, METAL, ORTHODONTIC | EJF | ORMCO CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |