FDA Adverse Event
Injury
Summary report: N
COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 6MM
MDR report key: 6179503
·
Received December 15, 2016
Report
- Report Number
- 6000034-2016-02463
- Event Type
- Injury
- Date Received
- December 15, 2016
- Date of Event
- November 28, 2016
- Report Date
- November 30, 2016
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- FZE
- PMA / PMN Number
- K945154
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY UNDER GENERAL ANESTHESIA TO EXCISE THE EXCESS SKIN AND FOR REMOVAL OF THE ABUTMENT ON (B)(6) 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 829925 | COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 6MM | COCHLEAR BAHA CONNECT SYSTEM | FZE | COCHLEAR BONE ANCHORED SOLUTIONS AB | 92996 | 152169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Required Intervention |