FDA Adverse Event
Injury
Summary report: N
BA400 ABUTMENT 6MM
MDR report key: 8485237
·
Received April 4, 2019
Report
- Report Number
- 6000034-2019-00462
- Event Type
- Injury
- Date Received
- April 4, 2019
- Report Date
- August 13, 2019
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K121317
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS, A SKIN REDUCTION WAS ALSO PERFORMED (DATE NOT REPORTED). THIS REPORT IS SUBMITTED ON SEPTEMBER 04, 2019.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON APRIL 05, 2019. (B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT IMPLANT SITE; SUBSEQUENTLY THE PATIENT'S ABUTMENT WAS REPLACED (DATE NOT REPORTED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277868 | BA400 ABUTMENT 6MM | COCHLEAR BAHA CONNECT SYSTEM | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 93333 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |