FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3041476
·
Received April 8, 2013
Report
- Report Number
- 6000034-2013-00638
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- February 25, 2013
- Report Date
- April 1, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT UNDERWENT TWO COURSE OF ANTIBIOTICS TO TREAT SKIN OVERGROWTH. ADDITIONALLY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2013 TO REMOVE GRANULATION TISSUE. IT WAS REPORTED THAT THE PATIENT HAS COMPLETELY RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143818 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 90434 | 009CMC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |