FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 1050262
·
Received May 22, 2008
Report
- Report Number
- 6000034-2008-00274
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- December 20, 2007
- Report Date
- May 22, 2008
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS
- Product Code
- LXB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS A FINAL REPORT. THE TYPE OF EVENT IS ADDRESS IN THE DEVICE LABELING.
Description of Event or Problem · 1
PER THE AUDIOLOGIST, THE PATIENT'S FLANGE FIXTURE WITH ABUTMENT FELL OUT IN LATE 2007. REPORTEDLY A MILD TRAUMA CAUSED THE FIXTURE TO FALL OUT. NO DETAILS ON THE TYPE OF TRAUMA WERE PROVIDED. A NEW FLANGE FIXTURE WITH ABUTMENT WAS PLACED IN 2008. THE FIXTURE WAS RETURNED TO THE MANUFACTURER BUT HAD NO BEEN STERILIZED. PER PROCEDURE, NO ANALYSIS WAS DONE ON THE FIXTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLANGE FIXTURE AND ABUTMENT | BONE-ANCHORED IMPLANT | LXB | COCHLEAR BONE ANCHORED SOLUTIONS | 90434 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |