BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDYS-ALIF TIVAC

    MDR report key: 18249265 · Received December 1, 2023

    Report

    Report Number
    3009962553-2003-00004
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 28, 2023
    Report Date
    December 1, 2023
    Manufacturer
    CLARIANCE SAS
    Product Code
    HRS
    PMA / PMN Number
    K191263
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539332 IDYS-ALIF TIVAC IDYS-ALIF PLATE H18MM HRS CLARIANCE SAS 24430018-S JA15C-K206Y

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown