BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 14855572 · Received June 29, 2022

    Report

    Report Number
    2135156-2022-00004
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    May 31, 2022
    Report Date
    June 29, 2022
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    OQB
    UDI-DI
    M74030030320
    PMA / PMN Number
    DEN200010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 OPTILIF PROCEDURE ON (B)(6) 2022 TO ADDRESS PATIENT RECURRENT NERVE ISSUES AT L5/S1, AS WELL AS POTENTIAL LOOSENED PEDICLE SCREWS AND TO PLACE AN INTERBODY FUSION DEVICE. DURING THE PROCEDURE, THE SURGEON INDICATED A PREVIOUSLY PLACED OPTIMESH DEVICE AT THE L5/S1 LEVEL WAS RETROPULSED INTO THE CANAL AREA. THE IMPLANT WAS REMOVED AND NO ALTERNATE INTERBODY DEVICE WAS PLACED IN THE DISC SPACE. THE PATIENT IS NO LONGER EXPERIENCING ANY CLINICAL ISSUES OR COMPLICATIONS. PLACEMENT OF THE ORIGINAL OPTIMESH DEVICE WAS CONFIRMED TO HAVE BEEN CONDUCTED ON (B)(6) 2021 AND THE PATIENT'S RECURRENT NERVE SYMPTOMS WERE REPORTED TO HAVE PRESENTED APPROXIMATELY ONE (1) MONTH POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956945 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY, INC. S21814 M74030030320

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other