FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 2801834
·
Received October 23, 2012
Report
- Report Number
- 6000034-2012-02005
- Event Type
- Injury
- Date Received
- October 23, 2012
- Report Date
- March 26, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: THE PATIENT WAS NOT REIMPLANTED WITH A NEW DEVICE AS PREVIOUSLY REPORTED, BUT IMPLANTED ON THE CONTRALATERAL SIDE. DEVICE IS NOT AVAILABLE FOR ANALYSIS. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PER THE PATIENT'S SURGEON, THE PATIENT EXPERIENCED THE LOSS OF OSSEOINTEGRATION ON (B)(6) 2010. IT WAS ALSO REPORTED THAT THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED (B)(4) 2013.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (DATE NOT REPORTED), RESULTING IN FIXTURE LOSS. THE PATIENT WAS IMPLANTED WITH A NEW DEVICE (DATE NOT REPORTED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |