FDA Adverse Event
Injury
Summary report: N
BIA400 IMPLANT 4MM W ABUTMENT 8MM
MDR report key: 5680146
·
Received May 25, 2016
Report
- Report Number
- 6000034-2016-01058
- Event Type
- Injury
- Date Received
- May 25, 2016
- Report Date
- April 11, 2017
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- MAH
- PMA / PMN Number
- K121317
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY UNAVAILABLE.
Additional Manufacturer Narrative · 1
CORRECTION: THE CORRECT BRAND NAME IS: 'BIA400 IMPLANT 4MM W ABUTMENT 8MM', NOT 'FLANGE FIXTURE AND ABUTMENT' AS PREVIOUSLY REPORTED. THE CORRECT COMMON DEVICE NAME IS COCHLEAR BAHA CONNECT SYSTEM, NOT 'LXB' AS PREVIOUSLY REPORTED. THE CORRECT PRODUCT CODE IS: MAH, NOT 'LXB' AS PREVIOUSLY REPORTED. THE CORRECT CATALOG # IS: 93330, NOT 92131 AS INITIALLY REPORTED. THE CORRECT 510(K) NUMBER IS 'K121317', NOT 'K984162' AS PREVIOUSLY REPORTED. THIS REPORT IS SUBMITTED JULY 5, 2017.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333716 | BIA400 IMPLANT 4MM W ABUTMENT 8MM | COCHLEAR BAHA CONNECT SYSTEM | MAH | COCHLEAR BONE ANCHORED SOLUTIONS AB | 93330 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |