BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE PROTI 5 DG, 9X11X27 MM

    MDR report key: 15182741 · Received August 8, 2022

    Report

    Report Number
    3012966183-2022-00028
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Report Date
    August 8, 2022
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917021318
    PMA / PMN Number
    K172185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOGRAPHIC IMAGING, DEVICE/LOT INFORMATION, AND ANY OTHER INFORMATION USED TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT WAS NOT PROVIDED AT THIS TIME. THEREFORE THE CONCLUSION OF THE INVESTIGATION IS "CAUSE NOT ESTABLISHED".

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A TLIF PROCEDURE (5/S) ON (B)(6) 2022. IT WAS FOUND ON AN UNKNOWN DATE THAT THE CAGE HAD BACKED OUT. THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE ON (B)(6). NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025752 CONCORDE PROTI 5 DG, 9X11X27 MM INTERBODY SPACER MAX TYBER MEDICAL 188827411 00819917021318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other