FDA Adverse Event
Injury
Summary report: N
VALEO PL
MDR report key: 2116452
·
Received June 1, 2011
Report
- Report Number
- 3005032068-2011-00004
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- August 24, 2009
- Report Date
- May 27, 2011
- Manufacturer
- AMEDICA CORP.
- Product Code
- MQP
- PMA / PMN Number
- K073505
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVENT REPORTED BY REQUEST OF FDA. ADD'L LOT# 900272. ADD'L DEVICE MFR DATE: 11/20/2008.
Description of Event or Problem · 1
VALEO PL SPACER(S) WERE REVISED DUE TO IMPLANT MIGRATION. THE SURGEON INDICATED THAT THE PT REPORTED LEG PAIN DURING THE F/U OF THE INITIAL SURGERY. X-RAYS CONFIRMED THAT THE IMPLANT HAD MIGRATED. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO CONTACT AND SCHEDULE A MEETING WITH THE SURGEON TO GO OVER THE DETAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VALEO PL | VERTEBRAL BODY REPLACEMENT | MQP | AMEDICA CORP. | 900180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |