BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE PROTI P, 9X7X27 MM

    MDR report key: 19931540 · Received August 7, 2024

    Report

    Report Number
    3012966183-2024-00009
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 7, 2024
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917021103
    PMA / PMN Number
    K180590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS INVESTIGATED WITHOUT THE REQUESTED RETURNED DEVICE, SPECIFIC LOT INFORMATION, OR IMAGING. A DEVICE EVALUATION COULD NOT BE PERFORMED AS THE AFFECTED DEVICE WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. A HISTORICAL DATA ANALYSIS REVEALED ONE ADDITIONAL COMPLAINT FOR THE PRODUCT SYSTEM, REGARDING NONUNION OF A PATIENT, WITHIN THE LAST 12 MONTHS. THE ROOT CAUSE CANNOT BE DETERMINED OR TRACED BACK TO THE DEVICE WITH THE INFORMATION PROVIDED. 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

    AS REPORTED FROM COMPLAINANT: IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION (L3/4/5) AND PLIF (L4/5) PERFORMED ON (B)(6), 2024. AFTER THE SURGERY, THE PSEUDOARTHROSIS DUE TO BONE FUSION FAILURE WAS CONFIRMED. THE REMOVAL SURGERY FOR INTERVERTEBRAL CAGE IN QUESTION AND POSTERIOR SCREW IN QUESTION WAS PERFORMED ON (B)(6), 2024. IN THE SURGERY, AFTER THE CAGE WAS REMOVED, THE PROTI CONCORDE 0° 9X7X27 WAS FOUND TO BE DAMAGED. THE FRAGMENT WAS IN THE BONE GRAFT SPACE OF THE CAGE AND NO INTERNAL REMAINS WERE OBSERVED. THE CAUSE IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. FURTHER ADDITIONAL INFORMATION RESPONSE FROM COMPLAINANT: - LOT NUMBER - NO FURTHER INFORMATION IS AVAILABLE. - ANY IMAGING RELATED TO THE (B)(6) 2024 ORIGINAL SURGERY. - NO FURTHER INFORMATION IS AVAILABLE. - ANY IMAGING RELATED TO THE (B)(6) 2024 REMOVAL SURGERY. - NO FURTHER INFORMATION IS AVAILABLE. - WAS THE DEVICE NOTICED TO BE DAMAGED DURING THE ORIGINAL SURGERY OR ON IMAGING? - IT WAS NOTICED DURING THE SECOND SURGERY. - WILL THE DEVICE BE MADE AVAILABLE FOR RETURN? - NO FURTHER INFORMATION IS AVAILABLE. - PATIENT DETAILS - AGE, HEIGHT, WEIGHT, COMORBIDITIES, CONDITIONS - NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262914 CONCORDE PROTI P, 9X7X27 MM INTERBODY SPACER MAX TYBER MEDICAL 188827107 00819917021103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention