FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3943091
·
Received July 18, 2014
Report
- Report Number
- 6000034-2014-00969
- Event Type
- Injury
- Date Received
- July 18, 2014
- Date of Event
- June 23, 2014
- Report Date
- September 17, 2014
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED SEPTEMBER 19, 2014.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS ON (B)(6) 2014. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421269 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 125092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |