FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3171017
·
Received June 14, 2013
Report
- Report Number
- 6000034-2013-01054
- Event Type
- Injury
- Date Received
- June 14, 2013
- Date of Event
- May 20, 2013
- Report Date
- July 5, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS FIXTURE IS NOT AVAILABLE FOR ANALYSIS. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION ON (B)(6) 2013, RESULTING IN FIXTURE LOSS. SURGERY TO ACCESS SLEEPER FIXTURE AND PLACE A NEW ABUTMENT OCCURRED ON (B)(6) 2013. DURING THE SAME PROCEDURE, A NEW SLEEPER FIXTURE WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270537 | FLANGE FIXTURE AND ABUTMENT | PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |