BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO II TL INTERBODY FUSION SYSTEM

    MDR report key: 20337076 · Received September 30, 2024

    Report

    Report Number
    3009051471-2024-00015
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 10, 2024
    Report Date
    September 30, 2024
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    MAX
    PMA / PMN Number
    K121892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED AS IT IS STILL IMPLANTED INTO PATIENT, THERE WAS NO HARM TO PATIENT NOR COMPLICATION OF PROCEDURE. THIS WAS A MISUSE BY HITTING THE INSERTER WITH A MALLET OUTSIDE THE PATIENT AT THE BACK TABLE TO COMPACT BONE GRAFT INTO THE CAGE. THIS CAUSED THE CAGE TO FRACTURE.

    Description of Event or Problem · 0

    ONE OF (B)(6) VALEO II TL CAGE IMPLANT WAS BEING INSERTED BY A SURGEON. THE SUBJECT IMPLANT WAS ATTACHED TO THE INSERTER AND BONE GRAFT WAS ADDED. THE SURGEON TOOK A MALLET TO THE PROXIMAL END OF THE INSERTER AND HIT IT TO PACK THE BONE GRAFT INTO THE IMPLANT. THE IMPLANT/INSERTER WAS THEN INSERTED INTO THE PATIENT AND WHEN THE INSERTER WAS TAKEN OFF OF THE IMPLANT, A SMALL FRAGMENT BROKEN OFF FROM THE CAGE WAS NOTICED. THE FRAGMENT WAS REMOVED AND WAS RETURNED TO (B)(6) FOR EVALUATION. THE REST OF THE IMPLANT WAS LEFT IN THE PATIENT. NO HARM TO THE PATIENT; PATIENT REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40506 VALEO II TL INTERBODY FUSION SYSTEM TLIF CAGE MAX CTL MEDICAL CORPORATION 11.111.2710 BI1930914

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown