FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3122793
·
Received May 21, 2013
Report
- Report Number
- 6000034-2013-00949
- Event Type
- Injury
- Date Received
- May 21, 2013
- Report Date
- May 10, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE EXCESS SKIN OVERGROWTH AND TO PLACE A LONGER ABUTMENT ON THE INTERNAL FIXTURE (DATE NOT REPORTED.) THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224945 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |