FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 1951320
·
Received January 6, 2011
Report
- Report Number
- 6000034-2011-00005
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 8, 2010
- Report Date
- April 7, 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
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AROUND THE IMPLANT SITE WITH SUBSEQUENT LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND BACTROBAN OINTMENT. SURGERY TO ACCESS THE SLEEPER SITE 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 | 7 YR | Required Intervention |