FDA Adverse Event
Injury
Summary report: N
BAHA FLANGE FIXTURE AND ABUTMENT
MDR report key: 4130162
·
Received September 30, 2014
Report
- Report Number
- 6000034-2014-01467
- Event Type
- Injury
- Date Received
- September 30, 2014
- Date of Event
- April 8, 2014
- Report Date
- September 15, 2014
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT DEVELOPED RECURRENT INFECTION AT THE ABUTMENT SITE AND WAS PRESCRIBED MULTIPLE COURSES OF ORAL ANTIBIOTICS BEGINNING (B)(6) 2014 THROUGH (B)(6) 2014 (DURATIONS NOT REPORTED); WITHOUT RESOLUTION. ON (B)(6) 2014 THE PATIENT WAS ADMINISTERED GENERAL ANESTHESIA TO FACILITATE WITH REMOVAL OF THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607579 | BAHA FLANGE FIXTURE AND ABUTMENT | LXB: PRODUCT CODE | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention |