BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 19346103 · Received May 17, 2024

    Report

    Report Number
    2135156-2024-00005
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 17, 2024
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    OQB
    UDI-DI
    M7403003440
    PMA / PMN Number
    K230927
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 ON (B)(6) 2023 WITHOUT INCIDENT. DURING A POST-OPERATIVE APPOINTMENT, IMAGING SHOWED THE IMPLANT PARTIALLY OUTSIDE OF THE DISC SPACE WITH LOSS OF GRAFT CONTAINMENT. A REVISION SURGERY WAS CONDUCTED APPROXIMATELY 10 MONTHS POST-OPERATIVE TO PLACE AN ADDITIONAL SMALLER OPTIMESH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671326 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY INC. S24943 M7403003440

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention