FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 2962555
·
Received February 14, 2013
Report
- Report Number
- 6000034-2013-00212
- Event Type
- Injury
- Date Received
- February 14, 2013
- Date of Event
- January 9, 2013
- Report Date
- January 28, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 EXPERIENCED A SKIN OVERGROWTH AND INFECTION AROUND THE ABUTMENT SITE ON (B)(6) 2012. THE PATIENT WAS TREATED WITH TOPICAL ANTIBIOTICS. THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2013 TO HAVE THE ABUTMENT REPLACED. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65934 | FLANGE FIXTURE AND ABUTMENT | LXB, PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention |