SECURE C

Additional Manufacturer Narrative

NEITHER THE DEVICE NOR ANY IMAGING WAS AVAILABLE FOR EVALUATION. IT WAS REPORTED THAT AFTER USING THE BROACHING CHISEL, THE SURGEON THEN ENCOUNTERED DIFFICULTY WHILE ADVANCING THE KEEL CHISEL OVER THE TRIAL AND USED MORE FORCE TO ADVANCE THE CHISEL OVER THE TRIAL TO ITS INTENDED POSITION, WHICH CAUSED THEM TO ADVANCE TOO FAR. NO FLUOROSCOPIC GUIDANCE WAS USED DURING THIS STEP AS RECOMMENDED IN THE SURGICAL TECHNIQUE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND NO PATIENT IMAGING WAS PROVIDED. THE 6MM AND 7MM TRIALS FROM THE SET WERE EVALUATED AND FUNCTIONED AS INTENDED. THE LACK OF FLUOROSCOPIC GUIDANCE WHILE ADVANCING THE CHISEL MAY HAVE CONTRIBUTED TO THIS EVENT; HOWEVER, THE EXACT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SECURE C CASE, THE TRIAL AND KEEL CHISEL WERE ADVANCED TOO FAR IN THE DISC SPACE DURING PREPARATION. FOLLOWING REMOVAL OF THE TRIAL, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SERIOUS ADVERSE EFFECT.