FDA Adverse Event
Injury
Summary report: N
TRANSCEND
MDR report key: 162160
·
Received April 10, 1998
Report
- Report Number
- 2020467-1998-00002
- Event Type
- Injury
- Date Received
- April 10, 1998
- Report Date
- March 31, 1998
- Manufacturer
- 3M UNITEK
- Product Code
- ECQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ORTHODONTIST STATED THAT THE UPPER PORTION OF A LOWER ANTERIOR TOOTH FRACTURED WHEN HE DEBONDED A TRANSCEND CERAMIC BRACKET. ORTHODONTIST STATED THAT THE EVENT OCCURRED 6 OR 7 YRS AGO AND THAT HE DOES NOT REMEMBER THE NAME OF THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSCEND | ORTHODONTIC CERAMIC BRACKET | ECQ | 3M UNITEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | ORTHODONTIC BONDING ADHESIVE, STAINLESS STEEL| 1989-1991.| BANDS, BUCCAL TUBES, ARCHWIRE. THERAPY DATES: |