FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3020266
·
Received March 25, 2013
Report
- Report Number
- 6000034-2013-00543
- Event Type
- Injury
- Date Received
- March 25, 2013
- Date of Event
- August 30, 2012
- Report Date
- March 14, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 TO EXCISE AN OVERGROWTH OF SKIN TISSUE AROUND THE IMPLANT SITE. THE ABUTMENT WAS REMOVED AND REPLACED WITH A LONGER MODEL DURING THE SAME PROCEDURE. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121448 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A | COH139324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |