FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 2944872
·
Received February 5, 2013
Report
- Report Number
- 6000034-2013-00233
- Event Type
- Injury
- Date Received
- February 5, 2013
- Date of Event
- January 30, 2013
- Report Date
- October 16, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE ABUTMENT WAS REMOVED ON (B)(6) 2013. THE IMPLANT STAYED INSITU AT ALL TIMES. THIS REPORT IS FILED OCTOBER 21, 2013.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013, TO REMOVE GRANULATION TISSUE AROUND THE ABUTMENT. IT WAS ALSO REPORTED THAT THE ABUTMENT HAS BEEN CHANGED PRIOR TO THE SKIN REVISION SURGERY (EXACT DATE NOT REPORTED).ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47957 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 902489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Required Intervention |