FDA Adverse Event
Injury
Summary report: N
COCHLEAR BAHA CONNECT
MDR report key: 5945489
·
Received September 13, 2016
Report
- Report Number
- 6000034-2016-01814
- Event Type
- Injury
- Date Received
- September 13, 2016
- Report Date
- August 25, 2016
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 0
DEVICE AND INITIAL IMPLANTATION DETAILS UNAVAILABLE AT THE TIME OF THIS REPORT, THIS REPORT IS FILED ON SEPTEMBER 13, 2016. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. H3 OTHER TEXT : IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. RE-IMPLANTATION IS PLANNED BUT HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT SEPTEMBER 13, 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 597150 | COCHLEAR BAHA CONNECT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |