FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 1982603
·
Received February 9, 2011
Report
- Report Number
- 6000034-2011-00085
- Event Type
- Injury
- Date Received
- February 9, 2011
- Date of Event
- December 26, 2010
- Report Date
- June 3, 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
(B)(4).
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED (B)(6), 2011.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THE PATIENT WAS ALSO TREATED WITH ANTIBIOTICS (TYPE NOT REPORTED). IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (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 | 68 YR | Required Intervention |