BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 11617625 · Received April 6, 2021

    Report

    Report Number
    3010266064-2021-00259
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    July 27, 2021
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE CORI CONSOLE P/N (B)(4) SN(B)(6) USED FOR TREATMENT WAS RETURNED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A FUNCTIONAL EVALUATION WAS PERFORMED. THE REPORTED PROBLEM WAS NOT CONFIRMED. A PERFORMANCE EVALUATION WAS RUN AND THE TEST PASSED. A CASE WAS COMPLETED WITHOUT ANY BONE GENERATION ISSUES. THE CONSOLE FUNCTIONS AS INTENDED. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. A FACTOR THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT WAS A SOFTWARE ANOMALY OCCURRED. BASED ON THE INVESTIGATION, NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORI CADAVER TRAINING LAB, THE TIBIAL BONE MODEL GENERATION ERROR OCCURRED FIVE TIMES BEFORE ALLOWING THEM TO PROCEED WITH MILLING. THEY ATTEMPTED TO ADD ADDITIONAL POINTS TWO TIMES BEFORE CLEARING AND REMAPPING. AFTER TWO MORE ATTEMPTS OF ADDING ADDITIONAL POINTS, IT FINALLY ALLOWED THEM TO PROCEED WITH MILLING. THERE WAS A DELAY OF FEWER THAN 30 MINUTES. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518122 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1