FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3070770
·
Received April 22, 2013
Report
- Report Number
- 6000034-2013-00718
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- February 23, 2013
- Report Date
- May 23, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CORRECTION: THE CORRECT CATALOG # US 92130; NOT 92127 AS PREVIOUSLY REPORTED. (B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2013, TO REMOVE EXCESS SKIN OVERGROWTH FROM AROUND THE ABUTMENT. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT RECEIVED ANTIBIOTICS (TYPE NOT SPECIFIED.) THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172923 | FLANGE FIXTURE AND ABUTMENT | LXB, PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 92127 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |