BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ELEMENTS CAGE

    MDR report key: 11783048 · Received May 5, 2021

    Report

    Report Number
    MW5101193
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 3, 2021
    Manufacturer
    SPINAL ELEMENTS INC.
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS IMPLANTING CAGE ON TLIF L4-L5, A PIECE FROM THE CORNER OF THE CAGE BROKE OFF. THE REMAINING PIECE OF CAGE SECURELY WAS IMPLANTED IN PATIENT, MD ASSESSED AND FELT CONFIDENT THE IMPLANTED PART OF THE CAGE WAS SAFE TO REMAIN IN THE PATIENT. SURGERY CONTINUED WITHOUT ISSUE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675834 SPINAL ELEMENTS CAGE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX SPINAL ELEMENTS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR