BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL PROTI 10X9X28 MM

    MDR report key: 17442815 · Received August 2, 2023

    Report

    Report Number
    3012966183-2023-00014
    Event Type
    Injury
    Date Received
    August 2, 2023
    Report Date
    August 2, 2023
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917021646
    PMA / PMN Number
    K172185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE COMPLAINT DEVICE WAS NOT RETURNED AND LOT IDENTIFYING INFORMATION WAS NOT PROVIDED, SO NEITHER A DEVICE EVALUATION NOR A DHR REVIEW FOR LOT RELATED NON-CONFORMANCES COULD BE PERFORMED. HOWEVER, PHYSICIAN FEEDBACK INDICATES THAT THE LOOSING OF THE CAGE WAS POTENTIALLY CAUSED BY THE LOOSING OF THE SCREWS WHICH WERE NOT TM PRODUCTS AND FRAGILE PATIENT ANATOMY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A TLIF (L4-5) FOR SPONDYLOLISTHESIS ON JANUARY 5, 2023. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, IT WAS CONFIRMED THAT THE T-PAL WAS COMING LOOSE, AND THE 4 SCREWS WERE LOOSE. ON UNKNOWN DATE, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, THE T-PAL WAS REMOVED, AND THE 4 SCREWS WERE REPLACED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE CAUSE OF LOOSENING IS UNKNOWN. THE SURGEON'S COMMENT ON THIS EVENT IS NONE. THE PATIENT'S BONE QUALITY WAS FRAGILE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796255 T-PAL PROTI 10X9X28 MM INTERBODY SPACERS MAX TYBER MEDICAL 108812009 00819917021646

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other