FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 2062688
·
Received April 19, 2011
Report
- Report Number
- 6000034-2011-00270
- Event Type
- Injury
- Date Received
- April 19, 2011
- Date of Event
- April 17, 2011
- Report Date
- August 22, 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
CORRECTION: THE CORRECT CATALOG # IS 90430; NOT 92134 AS PREVIOUSLY REPORTED. (B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE FIXTURE FAILED TO OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE 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 | 6 YR | Required Intervention |