FDA Adverse Event
Injury
Summary report: N
VALEO PL
MDR report key: 2116442
·
Received June 1, 2011
Report
- Report Number
- 3005032068-2011-00003
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- July 16, 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.
Description of Event or Problem · 1
TWO VALEO PL SPACERS WERE REVISED AND REMOVED DUE TO IMPLANT MIGRATION WITHIN THE DISC SPACE. THE SURGEON STATED THAT THE PT HAD HORRIBLE BONE. THE PT DENIED TRAUMA. THE SURGEON SUSPECTS TRAUMA, BECAUSE DURING THE REVISION SURGERY, IT WAS OBSERVED THAT THE PT HAD BRUISING ON THE LEGS AND BUTTOCKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VALEO PL | VERTEBRAL BODY REPLACEMENT | MQP | AMEDICA CORP. | VALEO PL | 900381 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |