FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3092653
·
Received May 3, 2013
Report
- Report Number
- 6000034-2013-00790
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- February 26, 2013
- Report Date
- September 24, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED OCTOBER 23, 2013.
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. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194315 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 92346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |