FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 1020949
·
Received March 28, 2008
Report
- Report Number
- 6000034-2008-00143
- Event Type
- Injury
- Date Received
- March 28, 2008
- Report Date
- March 28, 2008
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS
- Product Code
- LXB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS A FINAL REPORT. LABELING: THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.
Description of Event or Problem · 1
THIS REPORT IS BEING FILED RETROSPECTIVELY PER THE FDA'S REQUEST. THE FIXTURE REPORTEDLY FELL OUT ABOUT TWO MONTHS AFTER INITIAL SURGERY. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE MADE. HOWEVER, NO INFORMATION WAS PROVIDED. THE FLANGE FIXTURE AND ABUTMENT WERE ANALYZED AND FOUND TO BE WITHIN SPECIFICATIONS.
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 |