FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 2993592
·
Received March 7, 2013
Report
- Report Number
- 6000034-2013-00371
- Event Type
- Injury
- Date Received
- March 7, 2013
- Date of Event
- December 27, 2012
- Report Date
- May 21, 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
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4) THE IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
CORRECTION: THE CORRECT CATALOG # US 92132; NOT 92135 AS PREVIOUSLY REPORTED.THIS REPORT IS FILED JULY 24, 2013. IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AROUND THE IMPLANT SITE. THE PATIENT WAS PRESCRIBED ORAL AMOXICILLIN C. ON (B)(6) 2013. IT WAS ALSO REPORTED THAT, AS OF (B)(6) 2013, THE INFECTION HAD RESOLVED. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98254 | FLANGE FIXTURE AND ABUTMENT | LXB, PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |