BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 16969396 · Received May 19, 2023

    Report

    Report Number
    2135156-2023-00002
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 19, 2023
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    OQB
    UDI-DI
    M74030030320
    PMA / PMN Number
    DEN200010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 WITHOUT INCIDENT. APPROXIMATELY FOUR (4) WEEKS LATER, THE PATIENT EXPERIENCED RECURRING SYMPTOMS AND WAS NON-AMBULATORY, PROMPTING MEDICAL ATTENTION. IMAGING SHOWED POSTERIOR MIGRATION OF BONE GRAFT. A REVISION SURGERY WAS CONDUCTED ON (B)(6)2023 TO REMOVE THE BONE GRAFT AND REPLACE THE IMPLANT. FOLLOWING REVISION SURGERY, THE PATIENT IS AMBULATORY AND SYMPTOMS HAVE IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511061 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY INC. S24585 M74030030320

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention