FDA Adverse Event
Injury
Summary report: N
BIA400 IMPLANT 4MM W ABUTMENT 10MM
MDR report key: 13583562
·
Received February 23, 2022
Report
- Report Number
- 6000034-2022-00508
- Event Type
- Injury
- Date Received
- February 23, 2022
- Report Date
- March 14, 2022
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- MAH
- UDI-DI
- 09321502022712
- PMA / PMN Number
- K121317
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON FEBRUARY 23, 2022.
Additional Manufacturer Narrative · 0
CORRECTION: THE INITIAL MDR SUBMITTED ON FEBRUARY 23, 2022 WAS FILED INADVERTENTLY. NO DEVICE MALFUNCTION/ EXPLANTATION OR SERIOUS INJURY HAS OCCURRED. THIS REPORT IS SUBMITTED ON MARCH 31, 2022.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (DATE NOT REPORTED). REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1148332 | BIA400 IMPLANT 4MM W ABUTMENT 10MM | COCHLEAR BAHA CONNECT SYSTEM | MAH | COCHLEAR BONE ANCHORED SOLUTIONS AB | 93331 | 168520 | 09321502022712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |