IDYS-ALIF TIVAC

Additional Manufacturer Narrative

IT WAS REPORTED TO US THAT DURING IDYS-ALIF TIVAC SURGERY, UPON IMPACTION OF THE CAGE AND PLATE INTO THE DISC SPACE, TWO LOCKING RINGS SEPARATED FROM THE PLATE. THE TWO RINGS WERE RETRIEVED BY THE SURGEON. AS A CONSEQUENCE, 2 SCREWS WERE USED INSTEAD OF 4 TO SECURE THE PLATE. ORIGINALLY PLANNED IN THE PRE-OP STRATEGY, PEDICLE SCREWS WILL BE IMPLANTED. THIS EVENT IS REPORTABLE AS A MALFUNCTION.

Description of Event or Problem

SURGEON WAS USING IDYS ALIF TIVAC. DURING THE IMPACTION OF THE CAGE WITH THE PLATE ATTACHED TO THE CAGE TWO OF THE INFERIOR RINGS DISENGAGED FROM THE PLATE. SURGEON ENDED UP USING TWO SCREWS FROM AN INNOVASIS BUTTRESS PLATE SYSTEM AT THE BOTTOM SINCE HAD LARGER SCREW HEAD TO KEEP THE PLATE IN PLACE AND TWO OF IDYS ALIF SCREWS ON THE TOP SINCE THE RINGS WERE INTACT. THERE WAS NO HARM DONE TO THE PATIENT AND THE TIME ADDED TO THE PROCEDURE WAS MINIMAL. THE RINGS WERE DISCARDED BY THE OR STAFF AND ARE UNAVAILABLE FOR EVALUATION.

Additional Manufacturer Narrative

IT WAS REPORTED TO US THAT DURING IDYS-ALIF TIVAC SURGERY, UPON IMPACTION OF THE CAGE AND PLATE INTO THE DISC SPACE, TWO LOCKING RINGS SEPARATED FROM THE PLATE. THE TWO RINGS WERE RETRIEVED BY THE SURGEON. AS A CONSEQUENCE, 2 SCREWS WERE USED INSTEAD OF 4 TO SECURE THE PLATE. ORIGINALLY PLANNED IN THE PRE-OP STRATEGY, PEDICLE SCREWS WILL BE IMPLANTED. THIS EVENT IS REPORTABLE AS A MALFUNCTION. ON 02/28/2024: PER THE ANALYSIS REPORT FROM MANUFACTURER - THE PLATE USED WAS CONFORMING TO CLARIANCE'S SPECIFICATION (CONTROL REPORT AND RAW MATERIAL CERTIFICATES). THE SLEEVES WERE NOT RECOVERED BY CLARIANCE. NO ANALYSIS ON THE PARTS WAS POSSIBLE. VARIOUS WORKING HYPOTHESIS AND SCENARRI WERE INVESTIGATED WHILE IN CONDITIONS SIMILAR OR WORST CASE TO THE ONES REPORTED DURING THE SURGERY. CLARIANCE WAS ABLE TO REPRODUCE THE DISASSEMBLY OF THE SLEEVES FROM THE PLATE'S BODY WITH SLEEVES PLACED WITH AN EXTREME ANGLE. HOWEVER, THIS SITUATION DOES NOT PERFECTLY MATCH THIS INCIDENT CONTEXT AS THE SURGEON WAS EXPERIMENTED WITH THE PRODUCT AND WOULD HAVE SEEN THAT THE SLEEVES WHERE ABNORMALLY PROTRUDING. SAME COMMENT APPLIES FOR ITS STAFF THAT PREPARED THE CAGE AND PLATE PRIOR TO ITS INSERTION. WHILE SEVERAL HYPOTHESES WERE CONSIDERED, ROOT CAUSE WAS NOT CLEARLY IDENTIFIED.

Description of Event or Problem

SURGEON WAS USING IDYS ALIF TIVAC. DURING THE IMPACTION OF THE CAGE WITH THE PLATE ATTACHED TO THE CAGE TWO OF THE INFERIOR RINGS DISENGAGED FROM THE PLATE. SURGEON ENDED UP USING TWO SCREWS FROM AN INNOVASIS BUTTRESS PLATE SYSTEM AT THE BOTTOM SINCE HAD LARGER SCREW HEAD TO KEEP THE PLATE IN PLACE AND TWO OF IDYS ALIF SCREWS ON THE TOP SINCE THE RINGS WERE INTACT. THERE WAS NO HARM DONE TO THE PATIENT AND THE TIME ADDED TO THE PROCEDURE WAS MINIMAL. THE RINGS WERE DISCARDED BY THE OR STAFF AND ARE UNAVAILABLE FOR EVALUATION.