FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3071496
·
Received April 22, 2013
Report
- Report Number
- 6000034-2013-00723
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- April 12, 2013
- Report Date
- August 19, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K984162
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS ABUTMENT IS NOT AVAILABLE FOR ANALYSIS. (B)(4). DEVICE NOT AVAILABLE FOR ANALYSIS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED DIFFICULTIES USING THE EXTERNAL PROCESSOR DUE TO THE LOCATION OF THE IMPLANT SITE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2013, TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH A NEW DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171746 | FLANGE FIXTURE AND ABUTMENT | PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 90434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| R |