BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 22819518 · Received August 15, 2025

    Report

    Report Number
    2135156-2025-00003
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 15, 2025
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    OQB
    UDI-DI
    M74040026250
    PMA / PMN Number
    K231781
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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 ONE (1) MONTH LATER, THE PATIENT RETURNED WITH SYMPTOMS AND IMAGING SHOWED SLIGHT POSTERIOR MIGRATION OF THE IMPLANT WITHIN THE DISC SPACE AND PARTIALLY GRAFT MATERIAL EXPULSION INTO THE CANAL. A REVISION SURGERY WAS CONDUCTED TO REMOVE THE GRAFT MATERIAL AND PERFORM A DECOMPRESSION. FOLLOWING THE REVISION SURGICAL PROCEDURE, THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788544 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY INC. S27191 M74040026250

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention