FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3120810
·
Received May 20, 2013
Report
- Report Number
- 6000034-2013-00932
- Event Type
- Injury
- Date Received
- May 20, 2013
- Date of Event
- November 30, 2009
- Report Date
- May 8, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K984162
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 ON (B)(6) 2009. THE IMPLANTED DEVICE SUBSEQUENTLY LOST OSSEOINTEGRATION, RESULTING IN FIXTURE LOSS, WHICH WAS REPORTED IN MDR 6000034-2013-00838.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221584 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 90434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |