FDA Adverse Event
Injury
Summary report: N
4CIS VANE SPINE SYSTEM
MDR report key: 1575611
·
Received December 3, 2009
Report
- Report Number
- 3004941535-2009-00002
- Event Type
- Injury
- Date Received
- December 3, 2009
- Date of Event
- April 30, 2009
- Report Date
- November 9, 2009
- Manufacturer
- SOLCO BIOMEDICAL CO., LTD
- Product Code
- MNI
- PMA / PMN Number
- K081145
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NON-VANE PEDICLE SCREWS SET PRODUCT WAS USED WITH VANE PEDICLE SCREWS AGAINST INSTRUCTION FOR USED. CHECK INSTRUCTION FOR USE UNDER POSSIBLE ADVERSE EFFECT, IT IS LISTED THAT "IF USED WITH IMPROPER IMPLANT, MAY CAUSE FUSION CLOT AND CONTRIBUTE TO FAILURE IN FORMING PROPER FUSION." DEVICE MFR DATE 12/2008. ADDITIONAL CATALOG #: 4242-0001. ADDITIONAL LOT #: 7881208.
Description of Event or Problem · 1
NON SOLCO PRODUCT ROD WAS USED WITH SOLCO VANE PEDICLE SCREWS. SET SCREWS WERE LOOSENED AND ROD WAS NOT FULLY SEATED INTO SCREWS WHICH REQUIRED REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4CIS VANE SPINE SYSTEM | PEDICLE SCREW | MNI | SOLCO BIOMEDICAL CO., LTD | 9500807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |