BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 23385569 · Received October 24, 2025

    Report

    Report Number
    2135156-2025-00009
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 24, 2025
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    OQB
    UDI-DI
    M74030026280
    PMA / PMN Number
    K231781
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE 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. PURSUANT TO MANUFACTURER POLICY, EVENTS RESULTING IN A REVISION SURGERY ARE DEEMED A SERIOUS INJURY AS DEFINED IN 21 CFR 803.3 AND ARE DETERMINED TO BE MDR REPORTABLE EVENTS.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN OPTIMESH DEVICE WITHOUT INCIDENT. APPROXIMATELY TWO (2) YEARS LATER, IMAGING SHOWED A LACK OF IMPLANT FUSION. A REVISION SURGERY WAS CONDUCTED TO REMOVE AND REPLACE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703809 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY INC. S24404 M74030026280

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention