IDYS-TLIF TIVAC

Additional Manufacturer Narrative

WHILE USING A SLAP HAMMER TO GET THE INSERTER OUT OF THE DISC SPACE, THE PROXIMAL TANTALUM MARKER PORTION OF THE CAGE BROKE FROM THE REST OF THE CAGE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PORTION AND REMOVE IT FROM THE DISC SPACE. THEN, THE SURGEON WAS ABLE TO POSITION THE REST OF THE CAGE PROPERLY IN THE DISC SPACE.THIS EVENT IS REPORTABLE.

Description of Event or Problem

SURGEON WAS ON THE PATIENT'S RIGHT AT L2-3 USING 9MM TI COATED PEEL BANANA CAGE (REF= (B)(4)// LOT = N1A9X-N113Y). IMPLANT WAS IMPACTED INTO DISC SPACE AND ARTICULATED PROPERLY. THE WHEEL OF THE INSERTER WAS TURNED TO DISENGAGE THE IMPLANT AND A SLAP HAMMER WAS USED TO GET INSERTER OUT OF DISC SPACE. THE PROXIMAL TANTALUM MARKER PORTION OF THE IMPLANT BROKE FROM THE REST OF THE IMPLANT DURING THIS. THE BROKEN PIECE WAS RETRIEVED AND REMOVED FROM THE FIELD. THERE WAS NO HARM TO THE PATIENT AND NO DELAY TO SURGERY.