FDA Adverse Event
Injury
Summary report: N
APC II CLARITY METAL-REINFORCED CERAMIC BRACKET
MDR report key: 832330
·
Received March 27, 2007
Report
- Report Number
- 2020467-2007-00001
- Event Type
- Injury
- Date Received
- March 27, 2007
- Date of Event
- March 6, 2007
- Report Date
- March 19, 2007
- Manufacturer
- 3M UNITEK
- Product Code
- DYW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L CATALOG # 6700-744.
Description of Event or Problem · 1
ORTHODONTIC OFFICE REPORTED THAT DURING THE DEBONDING OF APC II CLARITY CERAMIC BRACKETS BY AN ORTHODONTIC TECHNICIAN, TOOTH DENTIN WAS EXPOSED WHEN A PIECE OF ENAMEL WAS REMOVED FROM PATIENT'S UPPER RIGHT AND LEFT SECOND BICUSPIDS AND ON A LOWER RIGHT SECOND BICUSPID. ORTHODONTIST REPAIRED PATIENT'S TEETH WITH COMPOSITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APC II CLARITY METAL-REINFORCED CERAMIC BRACKET | ORTHODONTIC CERAMIC BRACKET | DYW | 3M UNITEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ORTHODONTIC METAL BRACKETS AND ARCHWIRES| HOWE UTILITY PLIERS FOR DEBONDING THE BRACKETS |