IDYS-TLIF TIVAC
Received Jan 9, 2024 · Event occurred Dec 19, 2023
Report 3009962553-2023-00006 · MDR key 18480347
Device
Generic name
Idys-tlif Tivac Cage L29mm H09mm
Manufacturer
Clariance SasCatalog number
41532909-S
Lot number
N1A9X-N113Y
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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. ON (B)(6) 2024, IT WOULD APPEAR THAT ANGULATION IS EXERTED WHEN THE PATIENT'S ANATOMY IS COMPLICATED AS WELL AS WHEN USING THE PRODUCT WITH A MINIMALLY INVASIVE TECHNIQUE. THIS BRINGS US TO THE LIMITS OF THE TLIF TIVAC SYSTEM. THIS PROCEDURE IS, HOWEVER, NOT DESCRIBED IN THE SURGICAL TECHNIQUE.
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.
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 = 41532909-S // 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.