FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3864479
·
Received June 10, 2014
Report
- Report Number
- 6000034-2014-00836
- Event Type
- Injury
- Date Received
- June 10, 2014
- Report Date
- May 20, 2014
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE DEVICE IS CURRENTLY UNAVAILABLE.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LACK OF OSSEOINTEGRATION (DATE NOT REPORTED) RESULTING IN FIXTURE LOSS.THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341344 | FLANGE FIXTURE AND ABUTMENT | LXB: PRODUCT CODE | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 138479 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |