FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 2930591
·
Received January 28, 2013
Report
- Report Number
- 6000034-2013-00157
- Event Type
- Injury
- Date Received
- January 28, 2013
- Date of Event
- January 15, 2013
- Report Date
- September 6, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS FIXTURE IS NOT AVAILABLE FOR ANALYSIS. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT THE IMPLANT SITE, SUBSEQUENTLY CAUSING THE DEVICE TO EXTRUDE THROUGH THE SKIN. THE PATIENT WAS PRESCRIBED AUGMENTIN (DATE AND AMOUNT NOT REPORTED) FOR TREATMENT, HOWEVER; THE ISSUE COULD NOT BE RESOLVED. THE PATIENT UNDERWENT A PROCEDURE TO HAVE THE FIXTURE REMOVED ON (B)(6) 2013. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37134 | FLANGE FIXTURE AND ABUTMENT | PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |