FDA Adverse Event
Injury
Summary report: N
BIA400 IMPLANT 4MM W ABUTMENT 8MM
MDR report key: 7360447
·
Received March 21, 2018
Report
- Report Number
- 6000034-2018-00608
- Event Type
- Injury
- Date Received
- March 21, 2018
- Report Date
- March 5, 2018
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- MAH
- UDI-DI
- 09321502022705
- PMA / PMN Number
- K121317
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON MARCH 22, 2018, (B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION. CLINICAL MANAGEMENT IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 201637 | BIA400 IMPLANT 4MM W ABUTMENT 8MM | COCHLEAR BAHA CONNECT SYSTEM | MAH | COCHLEAR BONE ANCHORED SOLUTIONS AB | 93330 | COH1080103 | 09321502022705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |