FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3033464
·
Received April 3, 2013
Report
- Report Number
- 6000034-2013-00623
- Event Type
- Injury
- Date Received
- April 3, 2013
- Date of Event
- January 30, 2013
- Report Date
- March 14, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE ABUTMENT AND EXCESS SKIN OVERGROWTH WERE REMOVED ON (B)(6) 2013. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REPLACE THE ABUTMENT AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135697 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 92127 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Hospitalization| R |