FDA Adverse Event
Injury
Summary report: N
VALEO PL SYSTEM
MDR report key: 3232288
·
Received July 3, 2013
Report
- Report Number
- 3005032068-2013-00002
- Event Type
- Injury
- Date Received
- July 3, 2013
- Date of Event
- June 6, 2013
- Report Date
- July 3, 2013
- Manufacturer
- AMEDICA CORP.
- Product Code
- MAX
- PMA / PMN Number
- K091278
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE RETURNED TO AMEDICA FOR EVALUATION ON (B)(4) 2013. EVALUATION IS PENDING.
Description of Event or Problem · 1
DR PERFORMED A PLIF SURGERY ON (B)(6) 2013. THE 51 DAYS LATER, THE IMPLANT HAD MIGRATED CAUSING PAIN. THE IMPLANT WAS REMOVED IN A REVISION SURGERY. THE DR NOTED THAT THE DEVICE WAS SLIPPERY AND THE ENDPLATE HAD BEEN DAMAGED. THE DR ATTRIBUTED THE ENDPLATE DAMAGE TO THE IMPLANT. THE PT WAS DESCRIBED AS EXTREMELY DEGENERATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303750 | VALEO PL SYSTEM | INTERBODY FUSION DEVICE | MAX | AMEDICA CORP. | 900556 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |