FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3192916
·
Received June 27, 2013
Report
- Report Number
- 6000034-2013-01127
- Event Type
- Injury
- Date Received
- June 27, 2013
- Date of Event
- April 9, 2013
- Report Date
- June 14, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO EXCISE THE EXCESS SKIN AROUND THE ABUTMENT. DURING THIS PROCEDURE THE ABUTMENT WAS EXCHANGED. AS OF REPORTS ON (B)(6) 2013, THE INFECTION HAS CLEARED. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293603 | FLANGE FIXTURE AND ABUTMENT | LXB, PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 94965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |