FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 4191033
·
Received October 21, 2014
Report
- Report Number
- 6000034-2014-01557
- Event Type
- Injury
- Date Received
- October 21, 2014
- Date of Event
- August 20, 2014
- Report Date
- August 22, 2014
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K100360
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FIXTURE REMAINS INSITU.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT AND WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2014, IN ORDER TO REMOVE THE EXCESSIVE SKIN AND TO EQUIP THE PATIENT WITH A LONGER ABUTMENT. THE FIXTURE REMAINED INSITU AT ALL TIMES. THE ISSUE HAS BEEN RESOLVED AND THE PATIENT RESUMED USE OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670118 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |