BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFT TUBE

    MDR report key: 20081190 · Received August 27, 2024

    Report

    Report Number
    2135156-2024-00015
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 27, 2024
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    LXH
    UDI-DI
    M7403120056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 ON (B)(6) 2024. DURING THE SURGICAL PROCEDURE, MALLET IMPACT FORCES WERE APPLIED TO DEPLOY BONE GRAFT MATERIAL THROUGH THE GRAFT TUBE INSTRUMENT CAUSING THE GRAFT TUBE SHAFT TO DETACH FROM THE GRAFT TUBE FUNNEL HEAD. UPON FURTHER IMPACTION, THE SHAFT COMPONENT INADVERTENTLY ADVANCED VENTRAL TO THE ANTERIOR ANNULUS. THE SHAFT COMPONENT WAS RETRIEVED AND THE SURGEON CONFIRMED NO PATIENT INJURY OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478913 GRAFT TUBE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SPINEOLOGY INC. CH20003 M7403120056

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other