FDA Adverse Event
Other
Summary report: N
ST360 SPINAL FIXATION SYSTEM
MDR report key: 503120
·
Received December 26, 2003
Report
- Report Number
- 2184052-2003-00029
- Event Type
- Other
- Date Received
- December 26, 2003
- Date of Event
- November 26, 2003
- Report Date
- December 26, 2003
- Manufacturer
- CENTERPULSE SPINE-TECH
- Product Code
- MCV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT WAS ADMITTED TO SURGERY IN 2003 FOR IMPLANTATION OF AN THREE EVEL, BILATERAL ST360 STABILIZATION SYSTEM AT L3-L5. SURGEON WAS TORQUING DOWN A LOCKING NUT TO SECURE A SMALL CONNECTOR TO A 6.5 X 45MM PEDICLE SCREW (PART# 07.00319.035), AT L4, WHEN THE THREADED TOGGLE ON THE TOP OF THE SCREW BROKE OFF. THE SURGEON WAS NOT ABLE TO REMOVE THE CONNECTOR FROM THE PEDICLE SCREW AND MADE THE DECISION TO LEAVE THE SCREW AND CONNECTOR AS IS. THE SURGEON DID ADD TWO ADJUSTABLE TRANSVERSE CONNECTORS TO INCREASE TH STABILITY OF THE CONSTRUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ST360 SPINAL FIXATION SYSTEM | ST360 PEDICLE SCREW | MCV | CENTERPULSE SPINE-TECH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |