BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE EXPANDABLE INTERBODY FUSION DEVICE

    MDR report key: 12111349 · Received July 2, 2021

    Report

    Report Number
    2135156-2021-00003
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 8, 2021
    Report Date
    July 2, 2021
    Manufacturer
    SPINEOLOGY INC
    Product Code
    MAX
    UDI-DI
    M74054100080
    PMA / PMN Number
    K162879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE SURGEON: THE PATIENT UNDERWENT AN INTERBODY FUSION WITH PLACEMENT OF AN ELITE DEVICE ON (B)(6) 2021 WITHOUT INCIDENT. THE PATIENT WAS ASYMPTOMATIC AT A POST-OPERATIVE 4-MONTH ROUTINE FOLLOW-UP APPOINTMENT WITH NO IMPLANT ISSUES NOTED ON IMAGING. APPROXIMATELY ONE WEEK THEREAFTER, THE PATIENT REPORTEDLY BENT OVER AND HEARD A POP AND HAD ONSET NUMBNESS, PROMPTING ADDITIONAL MEDICAL ATTENTION. X-RAY IMAGING SHOWED A COLLAPSED IMPLANT WITH INTACT POSTERIOR INSTRUMENTATION. A REVISION SURGERY WAS CONDUCTED TO REMOVE THE COLLAPSED IMPLANT AND REPLACE WITH AN ALIF DEVICE WHILE PRESERVING THE ORIGINAL INTACT POSTERIOR CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004698 ELITE EXPANDABLE INTERBODY FUSION DEVICE INTERVERTEBRAL BODY FUSION DEVICE MAX SPINEOLOGY INC S91504 M74054100080

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other