FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3031664
·
Received April 2, 2013
Report
- Report Number
- 6000034-2013-00578
- Event Type
- Injury
- Date Received
- April 2, 2013
- Date of Event
- March 18, 2013
- Report Date
- March 18, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED ABNORMAL SOUND QUALITY WITH DEVICE USE, AND THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013, DURING WHICH THE ABUTMENT WAS REMOVED, AND THE PATIENT WAS IMPLANTED WITH A NEW FIXTURE AND ABUTMENT. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED IV ANTIBIOTICS DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135154 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A | 608586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |