BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE PROTI 5DG, 9X12X27MM

    MDR report key: 12353376 · Received August 23, 2021

    Report

    Report Number
    3012966183-2021-00021
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    June 7, 2021
    Report Date
    August 23, 2021
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    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 WAS PERFORMED ON THE PART NUMBER WHICH REVEALED 3 ADDITIONAL COMPLAINTS. ONE OF WHICH WAS FOR A SIMILAR COMPLAINT EVENT. THE RISK ADFMEA WAS REVIEWED WHICH IDENTIFIES THE COMPLAINT EVENT AS A POTENTIAL FAILURE MODE. THE ADFMEA POINT TO POTENTIAL CAUSES AS OVERSTRESSING. THERE WERE NO TRENDS IDENTIFIED, CAPAS, OR NON-CONFORMANCES FOR THIS PART NUMBER AT THE TIME OF THIS INVESTIGATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE IS INDETERMINATE.

    Description of Event or Problem · 1

    UNABLE TO CONNECT INSERTER TO BACK OF CAGE (EVIDENCE OF STRIPPING) CONCOMITANT DEVICE REPORTED: CONCORDE PROTI, 5DG,9X12X27 MM (PART# 188827412, LOT# UNKNOWN, QUANTITY UNKNOWN ) THIS COMPLAINT INVOLVES ONE (1) DEVICE. FURTHER INFORMATION STATES: CONTINUED UNTIL INSERTER COULD BE ENGAGED IN TO BACK OF IMPLANT. AND NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250995 CONCORDE PROTI 5DG, 9X12X27MM INTERBODY-CONCORDE MAX TYBER MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other