BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIX SPINAL IMPLANT SYSTEM

    MDR report key: 17355314 · Received July 19, 2023

    Report

    Report Number
    3005031160-2023-00011
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 19, 2023
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    MAX
    UDI-DI
    M697X03403871
    PMA / PMN Number
    K170119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT DESCRIBED THE WAY THE IMPLANT WAS DAMAGED AND STATED, "IMPLANT WAS PLACED PARTIALLY INTO THE VOID AND WAS TAPPED WITH A MALLET ON THE T HANDLE INSERTER. AFTER A FEW TAPS THE IMPLANT JUST FELL APART. THERE WAS NO TWISTING OR NON DIRECT FORCE APPLIED." A DHR REVIEW WAS PERFORMED FOR IMPLANT LOT AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE IMPLANT LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THE IMPLANT LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 8/22/2012. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE RELIABLY DETERMINED. THE COMPLAINANT PROVIDED PHOTOS OF THE COMPLAINT IMPLANT, WHICH SHOWED THE PROXIMAL END THAT ENGAGES WITH THE CALIX INSERTER HAD FRACTURED FROM THE BODY OF THE IMPLANT. IT WAS REPORTED THAT THE IMPLANT MALFUNCTION OCCURRED WHEN THE ATTACHED INSERTER WAS IMPACTED WITH A MALLET. IT MAY BE POSSIBLE FOR AN IMPLANT MALFUNCTION TO OCCUR WHEN THE ATTACHED INSERTER WAS IMPACTED IF EXCESSIVE FORCE WAS APPLIED. THE COMPLAINT IMPLANT HAS A 5° LORDOSIS AND A LARGER DISTAL END. IF THE IMPLANT WAS PLACED INTO A COLLAPSED DISC SPACE, THE INCREASED RESISTANCE MAY HAVE CONTRIBUTED TO EXCESSIVE FORCE PLACED ON THE INSERTER/IMPLANT INTERFACE. THE SYSTEM INSERTER HAS A THREADED ROD THAT ENGAGES WITH A MATCHING THREADED HOLE IN THE IMPLANT, WHICH IS ALSO PROXIMALLY SUPPORTED BY THE INSERTER. IF THE DISTAL END OF THE IMPLANT HAD RESISTANCE TO BEING PLACED INTO THE INTERVERTEBRAL SPACE, IT MAY BE POSSIBLE THAT THE FORCE COULD BE TRANSFERRED TO THE SMALLER PROXIMAL END OF THE IMPLANT/INSERTER INTERFACE AND RESULT IN THE OBSERVED IMPLANT MALFUNCTION. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THIS IMPLANT PRODUCT LINE FOR COMPLAINTS FROM THE FIELD.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 6/19/2023. IT WAS REPORTED THAT A 26MM X 10MM X 6MM X 5° PLIF IMPLANT MALFUNCTIONED WHEN BEING PLACED DURING A PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. THE MALFUNCTIONED IMPLANT WAS REMOVED, AND AN ALTERNATE AVAILABLE IMPLANT WAS SUCCESSFULLY UTILIZED TO COMPLETE THE SURGICAL PROCEDURE. THE COMPLAINT IMPLANT WAS DISCARDED AT THE SURGICAL FACILITY AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR ASSESSMENT. THE COMPLAINANT PROVIDED PHOTOS OF THE COMPLAINT IMPLANT, WHICH SHOWED THE PROXIMAL END THAT ENGAGES WITH THE SYSTEM INSERTER HAD FRACTURED FROM THE BODY OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883485 CALIX SPINAL IMPLANT SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX XTANT MEDICAL HOLDINGS, INC. X034-0387 039775 M697X03403871

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Other