BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE PROTI 5 DG 9.12.X 27MM

    MDR report key: 12059575 · Received June 24, 2021

    Report

    Report Number
    3012966183-2021-00014
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 24, 2021
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917021325
    PMA / PMN Number
    K172185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A HISTORICAL DATA REVIEW ON THE DEVICE WAS PERFORMED AND NO TREND WAS IDENTIFIED ON THE COMPLAINT EVENT. THERE WERE NO CAPAS OR NON-CONFORMANCES ON THE DEVICE. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE IS INDETERMINATE.

    Description of Event or Problem · 1

    REVISION OF TLIF L4-S1 - REVISION SURGERY TO REMOVE LOSE L4 SCREWS AND CAGE WHICH HE MOVED POSTERIORLY AND WAS OCCUPYING FORAMEN. PATIENT WAS EXPERIENCING ONLY MILD SYMPTOMS FOLLOWING PRIMARY PROCEDURE. L4 SCREWS WERE REPLACED AND CAGE REMOVED/REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957272 CONCORDE PROTI 5 DG 9.12.X 27MM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX TYBER MEDICAL 188827412 00819917021325

    Patients

    Seq Age Sex Outcome Treatment
    1 Other