BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 18385110 · Received December 22, 2023

    Report

    Report Number
    2135156-2023-00008
    Event Type
    Injury
    Date Received
    December 22, 2023
    Report Date
    December 22, 2023
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    OQB
    UDI-DI
    M74030034400
    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

    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 SIX (6) WEEKS LATER, THE PATIENT RETURNED AND REPORTED EXPERIENCING A HARD FALL AT APPROXIMATELY FIVE (5) WEEKS POST-OPERATIVELY. IMAGING SHOWED ANTERIOR MIGRATION OF THE IMPLANT. MEDICAL INTERVENTION MAY BE NECESSITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264719 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY INC. S25353 M74030034400

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other