FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 2921114
·
Received January 17, 2013
Report
- Report Number
- 6000034-2013-00134
- Event Type
- Injury
- Date Received
- January 17, 2013
- Report Date
- February 6, 2014
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS ABUTMENT IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED 28 MAR 2014.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED CHRONIC INFECTION AT THE IMPLANT SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTIC TREATMENT (AMOUNT AND TYPE NOT REPORTED) HOWEVER; THE ISSUE COULD NOT BE RESOLVED. THE PATIENT UNDERWENT A PROCEDURE TO HAVE THE ABUTMENT REMOVED (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6) 2013. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26898 | FLANGE FIXTURE AND ABUTMENT | PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |