FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3130382
·
Received May 24, 2013
Report
- Report Number
- 6000034-2013-00975
- Event Type
- Injury
- Date Received
- May 24, 2013
- Date of Event
- April 26, 2013
- Report Date
- July 17, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K984162
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: THE IMPLANTED DEVICE REMAINS, AND NO DEVICE ANALYSIS IS ANTICIPATED AS PREVIOUSLY REPORTED. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE ABUTMENT ON THE PATIENT'S FIXTURE BECAME LOOSE AND FELL OFF. A NEW ABUTMENT WAS PLACED UNDER SEDATION IN THE OPERATING ROOM ON (B)(6) 2013. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231251 | FLANGE FIXTURE AND ABUTMENT | PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 92126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention |