BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE EXPANDABLE INTERBODY FUSION SYSTEM

    MDR report key: 8695907 · Received June 13, 2019

    Report

    Report Number
    2135156-2019-00004
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 13, 2019
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    MAX
    UDI-DI
    M74054090010
    PMA / PMN Number
    K162879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN INTERBODY FUSION SURGERY WITH PLACEMENT OF AN ELITE EXPANDABLE DEVICE. DURING THE PROCEDURE IT WAS NOTICED THAT TWO OF THE TINES ON THE IMPLANT INSERTER HAD BROKEN. ONE FRAGMENT WAS LOCATED IN THE IRRIGATION CANISTER BUT THE OTHER FRAGMENT COULD NOT BE LOCATED. IT IS UNKNOWN IF THIS FRAGMENT WAS RETAINED WITHIN THE PATIENT OR IF IT RESIDED ELSEWHERE. NO PATIENT CONSEQUENCE HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488492 ELITE EXPANDABLE INTERBODY FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX SPINEOLOGY, INC. ST18013 M74054090010

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other