BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 17171205 · Received June 21, 2023

    Report

    Report Number
    2135156-2023-00004
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    May 5, 2023
    Report Date
    June 8, 2023
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    OQB
    UDI-DI
    M7403002628
    PMA / PMN Number
    DEN200010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 A TWO-LEVEL INTERBODY FUSION PROCEDURE WITH PLACEMENT OF TWO OPTIMESH DEVICES WITHOUT INCIDENT. APPROXIMATELY ONE (1) MONTH LATER, THE PATIENT EXPERIENCED RECURRING LEG PAIN, PROMPTING MEDICAL ATTENTION. IMAGING SHOWED OBSTRUCTION IN THE CANAL. A REVISION SURGERY WAS CONDUCTED TO REMOVE AND REPLACE BOTH IMPLANTS WITH A STATIC CAGE. THIS REPORT APPLIES TO OPTIMESH DEVICE ONE OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252236 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY INC. 10-10-100-4 S24404 M7403002628

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention