FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3192968
·
Received June 27, 2013
Report
- Report Number
- 6000034-2013-01153
- Event Type
- Injury
- Date Received
- June 27, 2013
- Date of Event
- June 14, 2013
- Report Date
- July 9, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS FIXTURE IS NOT AVAILABLE FOR ANALYSIS. (B)(4).
Description of Event or Problem · 1
PER THE CLINIC, DURING SECOND STAGE BAHA VISTAFIX SURGERY, THE FIXTURE WAS FOUND TO HAVE LOST OSSEOINTEGRATION. THE FIXTURE WAS REMOVED AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE ON (B)(6), 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292450 | FLANGE FIXTURE AND ABUTMENT | PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |