BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCORDE PROTI 360

    MDR report key: 10334023 · Received July 28, 2020

    Report

    Report Number
    3012966183-2020-00005
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    July 15, 2020
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917021103
    PMA / PMN Number
    K172185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INVESTIGATION, THERE WAS NO CAPA AND NO TRENDS ASSOCIATED WITH THIS EVENT TYPE. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION, AND THEREFORE CANNOT BE EVALUATED. A DHR REVIEW OF LOT 159309 WAS CONDUCTED. THERE WAS ONE NONCONFORMANCE ASSOCIATED WITH THIS TYPE OF FAILURE FOR THIS MANUFACTURING LOT. 4 PIECES WERE IDENTIFIED WITH CHIPPED COATING, AND WERE SCRAPPED. THE LOT MET RELEASE REQUIREMENTS. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    "ON (B)(6) 2020, MIS-TLIF WAS PERFORMED IN L2/3. THE PROCEDURE WAS DELAYED MORE THAN 30 MINUTES. ON (B)(6) 2020, THE SURGEON REPORTED THAT A REMOVAL PROCEDURE WOULD BE HELD BECAUSE THE PATIENT'S INFECTION WAS SUSPECTED. ON (B)(6) 2020, THE PROCEDURE WAS PERFORMED TO REMOVE THE CONCORDE DEVICE(S) AND TRANSPLANT THE ILIUM. THERE WAS NO NOTABLE DAMAGE OR PEELING OF THE COATING ON THE DEVICE IN QUESTION. NO FURTHER INFORMATION IS AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796889 CONCORDE PROTI 360 INTERBODY SPACER SYSTEM MAX TYBER MEDICAL 188827107 159309 00819917021103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention