BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMESH

    MDR report key: 23041804 · Received September 12, 2025

    Report

    Report Number
    2135156-2025-00005
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 12, 2025
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    OQB
    PMA / PMN Number
    K230927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT SERVES AS A CORRECTION TO THE INITIAL 30-DAY REPORT SUBMITTED ON 12-SEP-2025. SECTION H1, TYPE OF REPORTABLE EVENT, HAS BEEN CORRECTED TO INDICATE A 'MALFUNCTION' RATHER THAN A 'SERIOUS INJURY'.

    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.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN OPTIMESH DEVICE WITHOUT INCIDENT. APPROXIMATELY ONE (1) YEAR LATER, THE PATIENT RETURNED WITH SYMPTOMS AND IMAGING SHOWED PARTIAL MIGRATION OF THE IMPLANT INTO THE SPINAL CANAL. MEDICAL INTERVENTION HAS BEEN DEEMED NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410130 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY INC. S26010

    Patients

    Seq Age Sex Outcome Treatment
    1