FDA Adverse Event
Injury
Summary report: N
INCOGNITO LINGUAL BRACKET
MDR report key: 2192442
·
Received June 10, 2011
Report
- Report Number
- 2020467-2011-00002
- Event Type
- Injury
- Date Received
- June 10, 2011
- Date of Event
- March 15, 2010
- Report Date
- May 9, 2011
- Manufacturer
- 3M UNITEK
- Product Code
- EJF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
INCIDENT REPORTED (B)(4), 2011 BY DOCTOR DURING A VISIT TO 3M UNITEK FACILITY. INCIDENT OCCURRED (B)(6), 2010.
Description of Event or Problem · 1
DURING DEBONDING OF AN INCOGNITO LINGUAL BRACKET FROM PATIENT'S LOWER LEFT 2ND MOLAR, A LAYER OF ENAMEL CAME OFF THE TOOTH AND REMAINED STUCK TO THE BRACKET. THE ORTHODONTIST ADDED ADHESIVE AS A FILL IN WHERE THE ENAMEL CAME OFF. PER THE DOCTOR, THE TOOTH HAD A LARGE MESIAL/OCCLUSAL/DISTAL FILLING IN IT. PATIENT WAS NOT SENT TO A DENTIST, NOR WAS A CROWN RECOMMEND FOR THAT TOOTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INCOGNITO LINGUAL BRACKET | BRACKET, METAL, ORTHODONTIC (EJF) | EJF | 3M UNITEK | CUSTOM BRACKET |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |