FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 1896987
·
Received November 11, 2010
Report
- Report Number
- 6000034-2010-00693
- Event Type
- Injury
- Date Received
- November 11, 2010
- Date of Event
- October 19, 2010
- Report Date
- May 23, 2011
- 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
THE FIXTURE AND ABUTMENT WERE NOT RETURNED FOR ANALYSIS; ONLY THE SNAP COUPLING WAS RETURNED AND ANALYZED. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
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 | 70 YR | Required Intervention |