FDA Adverse Event
Malfunction
Summary report: N
VALEO TL
MDR report key: 4137818
·
Received September 29, 2014
Report
- Report Number
- 3005032068-2014-00004
- Event Type
- Malfunction
- Date Received
- September 29, 2014
- Date of Event
- August 20, 2014
- Report Date
- September 30, 2014
- Manufacturer
- AMEDICA CORP.
- Product Code
- ODP
- PMA / PMN Number
- K091278
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PATIENT WAS ORIGINALLY OPERATED ON (B)(6) 2014 AND REVISED ON (B)(6) 2014. AN 11MM VALEO TL INTERBODY THAT WAS USED. MR (B)(6) REMOVED THE CAGE WHEN REVISED AFTER THE PATIENT REPORTED FURTHER PAIN AND FELT MOVEMENT OF THE CAGE WHEN MOVING AT HOME. HE REINSERTED THE ROD TO LOCK THE CONSTRUCT WITHOUT PLACING ANOTHER INTERBODY. HE IS AWARE THAT THE CAGE WASN'T MEDICAL ENOUGH ALTHOUGH HE WAS HAPPY WITH ITS PLACEMENT ANTERIORLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606742 | VALEO TL | INTERBODY FUSION DEVICE | ODP | AMEDICA CORP. | NA | 900468 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |