BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-PAC

    MDR report key: 19105751 · Received April 15, 2024

    Report

    Report Number
    3007289746-2024-00001
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 14, 2024
    Report Date
    April 12, 2024
    Manufacturer
    EXPANDING INNOVATIONS, INC.
    Product Code
    MAX
    UDI-DI
    00850041805016
    PMA / PMN Number
    K223174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EI'S VISUAL INSPECTION OF THE EXPLANTED CAGE AT 10X MAGNIFICATION SHOWED NO DAMAGE TO THE LOCKING TEETH, NOR TO ANY OF THE OTHER CAGE COMPONENTS. FUNCTIONAL VERIFICATION SHOWED THAT THE CAGE WAS FOUND TO EXPAND AND RETRACT AS DESIGNED. NO ANOMALIES WERE NOTED ON THE RETURNED IMPLANT THAT COULD RESULT IN THE LOSS IN HEIGHT OF THE IMPLANT. REVIEW OF PRODUCTION RECORDS SHOWED THAT THE DEVICE LOT MET ALL RELEASE CRITERIA WITH NO NONCONFORMANCES REPORTED. BASED ON THE ABOVE INVESTIGATION, THE CAUSE OF THE LOSS IN HEIGHT CANNOT BE ATTRIBUTED TO AN IMPLANT MALFUNCTION. THE OBSERVED OCCURRENCE WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    EXPANDING INNOVATIONS INC., (EI) WAS NOTIFIED ABOUT A SURGERY IN WHICH THE X-PAC LATERAL CAGE THAT WAS IMPLANTED INTO THE L4-L5 DISC SPACE HAD, APPROXIMATELY THREE MONTHS POST OP, SUBSEQUENTLY EXPERIENCED A REDUCTION IN HEIGHT. THE SURGEON INFORMED EI COMPANY REPRESENTATIVES THAT THE CAGE WOULD REQUIRE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808418 X-PAC INTERVERTEBRAL BODY FUSION DEVICE MAX EXPANDING INNOVATIONS, INC. 20230117-08FA 00850041805016

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention