FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 1862538
·
Received October 8, 2010
Report
- Report Number
- 6000034-2010-00649
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- May 5, 2008
- Report Date
- October 12, 2010
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
(B)(4). DEVICE NOT AVAILABLE FOR ANALYSIS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED AN EPIDURAL HEMATOMA POST-OPERATIVELY. THE PATIENT UNDERWENT A CRANIOTOMY AND EVACUATION OF THE HEMATOMA. THE PATIENT RECOVERED SUCCESSFULLY.
Description of Event or Problem · 1
ETHIBOND EXCEL GREEN BRAIDED POLYESTER SUTURE 2-0, (3.0 METRIC) 36" HAS BEEN MISTHREADED ON MULTIPLE OCCASIONS ONTO THE SH 26MM 1/2C TAPER. WHEN THE SUTURE KIT HAS BEEN STARTED IT TIGHTENS UP AND WILL NOT PULL OUT AND ANOTHER ONE HAS TO BE STARTED. I HAVE FOUR (4) IN MY POSSESSION. THEY SEEM TO BE THREADED WRONG AT THE MANUFACTURING SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Hospitalization| L| R |