BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 16418765 · Received February 22, 2023

    Report

    Report Number
    2135156-2023-00001
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    January 25, 2023
    Report Date
    February 22, 2023
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    OQB
    UDI-DI
    M74030034400
    PMA / PMN Number
    DEN200010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO 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 EXPERIENCED RECURRING BACK PAIN, PROMPTING MEDICAL ATTENTION. IMAGING SHOWED PRESENCE OF BONE GRAFT IN THE FORAMINAL SPACE PER SURGEON INTERPRETATION. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2023 TO REMOVE AND REPLACE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407840 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY INC. S24136 M74030034400

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention