TAURUS PEDICLE SCREW SYSTEM
Received Jun 24, 2026 · Event occurred May 28, 2026
Report 3009051471-2026-00009 · MDR key 25610774
Device
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
TAURUS SCREW BODY WAS REPORTED TO HAVE SEPARATED FROM HOUSING WHEN PLACING THE ROD FOLLOWED BY THE SET SCREW. AS THE SURGEON WAS ABLE TO RE-INSERT USING THE SAME SCREW SHANK AND HEAD WITH NO ISSUE, THIS INDICATES THAT THERE WAS AN INITIAL FAILURE OF CONNECTION MECHANISM (POOR ASSEMBLY). ROOT CAUSE IS ATTRIBUTED TO IMPROPER ASSEMBLY ON THE FIRST ATTEMPT RESULTING IN THE SCREW BODY NOT ENGAGING FULLY WITH THE HOUSING.
Description of Event or Problem
THE SURGEON PLACED SIX TAURUS HEADLESS SCREWS USING THE GLOBUS EXCELSIUS ROBOT, THEN USED THE THREADED TULIP INSERTER TO APPLY THE HEAD-BODIES ONTO THE SHANKS. WHEN HE PLACED THE RODS FOLLOWED BY THE SET SCREW, ONE OF THE HEAD-BODIES BECAME COMPLETELY DETACHED FROM THE SHANK, AND THE INTERLOCKING MECHANISM (GOLD COMPONENT) WAS NO LONGER SEATED IN THE HEAD-BODY. THE SET SCREW AND ROD WERE REMOVED, AS WELL AS THE ENTIRE SCREW. THE INTERLOCKING MECHANISM WAS RE-INSERTED, AND THE SAME HEAD-BODY WAS REAPPLIED TO THE SHANK BEFORE THE SCREW WAS MANUALLY REINSERTED INTO THE PATIENT USING A TRADITIONAL THREADED TAURUS SCREWDRIVER. NO HARM TO THE PATIENT OCCURRED. NOTE: THE SURGEON COULD NOT CONFIRM THE SCREW SIZE USED, BUT SUGGESTED IT WAS MOST LIKELY 7.5 X 55MM.