FDA Adverse Event
Malfunction
Summary report: N
VALEO TL SYSTEM
MDR report key: 3350365
·
Received August 27, 2013
Report
- Report Number
- 3005032068-2013-00003
- Event Type
- Malfunction
- Date Received
- August 27, 2013
- Date of Event
- July 26, 2013
- Report Date
- August 27, 2013
- Manufacturer
- AMEDICA CORP.
- Product Code
- MAX
- PMA / PMN Number
- K091278
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE RETURNED TO AMEDICA FOR EVAL (B)(4) 2013.
Description of Event or Problem · 1
DR PERFORMED A REVISION SURGERY TO REMOVE AN INTERBODY FUSION IMPLANT THAT HAS MIGRATED. DR STATED THAT BONE CONDITION AND THE SIZE OF THE IMPLANT (UNDERSIZED) MIGHT HAVE BEEN FACTORS IN THE IMPLANT MIGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420549 | VALEO TL SYSTEM | INTERBODY FUSION DEVICE | MAX | AMEDICA CORP. | 900461 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |