BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCORDE PROTI 5 DG, 9X8X27 MM

    MDR report key: 17342308 · Received July 18, 2023

    Report

    Report Number
    3012966183-2023-00013
    Event Type
    Injury
    Date Received
    July 18, 2023
    Report Date
    July 18, 2023
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917021288
    PMA / PMN Number
    K172185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION WAS NOT POSSIBLE.LOT 132722 WAS MANUFACTURED ON 12/26/2018. ALL DEVICES FROM THE LOT WERE MANUFACTURED PER DEVICE SPECIFICATIONS. THERE ARE NO NO-CONFORMANCES OR CAPAS ASSOCIATED WITH THIS LOT. ROOT CAUSE CANNOT BE DETERMINED OR TRACED BACK TO THE DEVICE WITH THE INFORMATION PROVIDED. THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION. HOWEVER, NON-UNION IS A KNOWN PROCEDURAL RISK FOR LUMBAR SPINAL FUSION THAT IS OFTEN CAUSED BY PATIENT CONDITIONS THAT ARE ENTIRELY UNRELATED TO DEVICE PERFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A PLIF (L5/S1) FOR SPINAL STENOSIS ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, IN (B)(6) 2023, A REVISION SURGERY DUE TO NON-UNION WILL BE PERFORMED. IN THE REVISION SURGERY, THE CAGES IN QUESTION WILL BE REMOVED AND REPLACED WITH DIFFERENT SIZED CAGES. CAUSES OF THE EVENT ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109793 CONCORDE PROTI 5 DG, 9X8X27 MM INTERBODY SPACER MAX TYBER MEDICAL 188827408 132722 00819917021288

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other