BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 12304790 · Received August 10, 2021

    Report

    Report Number
    2135156-2021-00005
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    July 1, 2021
    Report Date
    August 10, 2021
    Manufacturer
    SPINEOLOGY, INC
    Product Code
    OQB
    PMA / PMN Number
    DEN200010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OF ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY OR DEATH.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN OPTIMESH DEVICE WITH BONE GRAFT ON (B)(6) 2021. FOLLOWING PLACEMENT OF THE DEVICE, IMAGES SHOWED THE MESH IMPLANT PARTIALLY THROUGH THE VENTRAL ANNULUS. A CTA DIAGNOSTIC RAISED CONCERN THE MESH MAY BE RESTRICTING FLOW TO AN ARTERY. ONE DAY LATER, A REVISION SURGICAL PROCEDURE WAS CONDUCTED VIA ANTERIOR APPROACH TO REMOVE THE MESH IMPLANT AND REPLACED WITH AN ALTERNATE INTERBODY FUSION DEVICE. THE REOPERATION WAS COMPLETED AS INTENDED AND WITHOUT PATIENT CONSEQUENCE. THE PATIENT HAS NO CLINICAL ISSUES OR COMPLICATIONS AND IS DOING WELL PER THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201881 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY, INC S21620

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention