BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMESH 1500 E

    MDR report key: 12848562 · Received November 19, 2021

    Report

    Report Number
    2135156-2021-00006
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 12, 2021
    Report Date
    November 19, 2021
    Manufacturer
    SPINEOLOGY, INC
    Product Code
    EZX
    UDI-DI
    M74033022050
    PMA / PMN Number
    K014200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AS REPORTED BY THE SURGEON: THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN OPTIMESH DEVICE WITH BONE GRAFT ON (B)(6) 2021 WITHOUT INCIDENT. APPROXIMATELY FOUR (4) TO SIX (6) WEEKS POST-OPERATIVE, THE PATIENT WAS ENGAGING IN HIGH IMPACT PHYSICAL THERAPY, NOT PRESCRIBED BY THE PHYSICIAN, AND PRESENTED NEW ONSET RADICULOPATHY PAIN PROMPTING MEDICAL ATTENTION. IMAGING SHOWED THE MESH IMPLANT RETROPULSED PARTIALLY INTO THE SPINAL CANAL. A REVISION SURGERY WAS CONDUCTED TO REMOVE THE IMPLANT PRESERVING SOME BONE GRAFT IN THE DISC SPACE. THE PATIENT IS NO LONGER EXPERIENCING ANY CLINICAL ISSUES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747227 OPTIMESH 1500 E GRAFT CONTAINMENT DEVICE EZX SPINEOLOGY, INC S81552 M74033022050

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown Other