BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 23194266 · Received October 1, 2025

    Report

    Report Number
    2135156-2025-00007
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    September 2, 2025
    Report Date
    October 1, 2025
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    OQB
    PMA / PMN Number
    K230927
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 OPTIMESH DEVICES AT THREE CONTIGUOUS LEVELS IN THE LUMBAR SPINE WITHOUT INCIDENT. APPROXIMATELY SIX (6) MONTHS LATER, IMAGING SHOWED SOME LOSS OF DISC HEIGHT AT TWO OF THE THREE LEVELS. APPROXIMATELY TWO (2) YEARS LATER, THE PATIENT RETURNED WITH SYMPTOMS AND IMAGING SHOWED FURTHER LOSS OF DISC HEIGHT AT THE SAME TWO LEVELS AND POSTERIOR CONSTRUCT FAILURE. MEDICAL INTERVENTION HAS BEEN DEEMED NECESSARY. THIS REPORT APPLIES TO OPTIMESH DEVICE TWO OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586791 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention