FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3292041
·
Received August 16, 2013
Report
- Report Number
- 6000034-2013-01459
- Event Type
- Injury
- Date Received
- August 16, 2013
- Report Date
- August 20, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER THE SURGEON, THE PATIENT REPORTEDLY DEVELOPED AN INFECTION AROUND THE ABUTMENT SITE, AND THE SITE WAS SUBSEQUENTLY DEBRIDED ON (B)(6) 2013. ON (B)(6) 2013, THE ABUTMENT WAS REMOVED FROM THE FIXTURE. THIS REPORT IS FILED OCTOBER 23, 2013. IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, ON (B)(6) 2013, THE PATIENT PRESENTED WITH EXPOSED BONE AROUND THE IMPLANT SITE. 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 |
|---|---|---|---|---|---|---|---|
| 397419 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |