FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 6452523
·
Received April 3, 2017
Report
- Report Number
- 6000034-2017-00591
- Event Type
- Injury
- Date Received
- April 3, 2017
- Date of Event
- February 7, 2017
- Report Date
- March 14, 2017
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON APRIL 03, 2017. (B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION ON (B)(6) 2017, RESULTING IN FIXTURE LOSS. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT APRIL 03, 2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236411 | UNKNOWN | COCHLEAR BAHA CONNECT SYSTEM | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |