FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 7054819
·
Received November 22, 2017
Report
- Report Number
- 6000034-2017-02205
- Event Type
- Injury
- Date Received
- November 22, 2017
- Report Date
- August 21, 2017
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON NOVEMBER 23, 2017. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO A LOSS OF OSSEOINTEGRATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, NOVEMBER 23, 2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 833436 | UNKNOWN | COCHLEAR BAHA CONNECT SYSTEM | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |