FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 5998748
·
Received October 4, 2016
Report
- Report Number
- 6000034-2016-01924
- Event Type
- Injury
- Date Received
- October 4, 2016
- Date of Event
- June 4, 2016
- Report Date
- September 12, 2016
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K100360
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
REGISTRATION NUMBER 3009092818 EXEMPTION NUMBER E2016011. THIS REPORT IS FILED ON OCTOBER 05, 2016.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (B)(6) 2016 RESULTING IN FIXTURE LOSS. RE-IMPLANTATION IS PLANNED BUT HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT OCTOBER 05, 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 647119 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Required Intervention |