FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 2063498
·
Received April 19, 2011
Report
- Report Number
- 6000034-2011-00276
- Event Type
- Injury
- Date Received
- April 19, 2011
- Date of Event
- January 1, 1998
- Report Date
- November 2, 2010
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4): DEVICES NOT AVAILABLE FOR ANALYSIS.
Description of Event or Problem · 1
THE MANUFACTURER BECAME AWARE FOLLOWING THE PUBLICATION OF A JOURNAL ARTICLE. BETWEEN THE YEARS 1998 AND 2008, 30 PATIENTS UNDERWENT REVISION SURGERY FOR TISSUE-RELATED PROBLEMS. FOUR DEVICES WERE EXPLANTED AND BILATERAL EXTRUSION WAS REPORTED FOR ONE PATIENT. INDIVIDUAL PATIENTS WERE NOT IDENTIFIED AND NO COMPLAINTS WERE REPORTED TO THE MANUFACTURER. ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |