FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 2223673
·
Received August 25, 2011
Report
- Report Number
- 6000034-2011-00636
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- June 20, 2011
- Report Date
- February 9, 2012
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT SUSTAINED A BLOW TO THE HEAD RESULTING IN A LOSS OF OSSEOINTEGRATION AND SUBSEQUENT FIXTURE LOSS. THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE ON (B)(6), 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |