BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 19839210 · Received July 26, 2024

    Report

    Report Number
    2135156-2024-00014
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 26, 2024
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    OQB
    UDI-DI
    M7403003032
    PMA / PMN Number
    K230927
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN INTERBODY FUSION DEVICE ON (B)(6) 2024. DURING THE SURGICAL PROCEDURE, THE DISTAL TIP OF A BONE FILL TUBE BENT WHEN FILLING THE IMPLANT AND COULD NOT BE EASILY REMOVED FROM THE INSERTER. UPON FORCEFUL REMOVAL, THE INSERTER ASSEMBLY WITHDREW FROM THE ACCESS TUBE SHEARING OFF THE BENT DISTAL TIP OF THE BONE FILL TUBE AND UNINTENTIONALLY RELEASING THE MESH IMPLANT. A SEPARATE INCISION AND SURGICAL APPROACH WERE NECESSARY TO REMOVE THE SHEARED TIP AND REPLACE THE PARTIALLY FILLED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922652 OPTIMESH INTERVERTEBRAL BODY GRAFT CONTAINMENT OQB SPINEOLOGY INC. M7403003032

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention