BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 14069103 · Received April 9, 2022

    Report

    Report Number
    3010266064-2022-00275
    Event Type
    Malfunction
    Date Received
    April 9, 2022
    Date of Event
    March 19, 2022
    Report Date
    July 1, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE(B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE REAL INTELLIGENCE CORI, PN: ROB10024, SN: (B)(6) USED FOR TREATMENT WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION, THEREFORE VISUAL AND FUNCTIONAL INSPECTIONS COULD NOT BE PERFORMED. THE CASE FILES WERE PROVIDED AND REVIEWED. SCREENSHOTS CONFIRMED THE BLOCK MODEL OVERLAPPING THE BONE MODELS IN THE IMPLANT PLANNING SCREEN AND GAP ASSESSMENT SCREEN. THE MOST LIKELY CAUSE OF THE REPORTED ISSUE IS A KNOWN SOFTWARE ISSUE ASSOCIATED WITH THE MESH GENERATION. A BUG HAS BEEN IDENTIFIED FOR THIS ISSUE AND IS UNDER FURTHER INVESTIGATED BY THE SOFTWARE ENGINEERING TEAM. THIS SITUATION IS CAPTURED IN THE RISK ASSESSMENT RELEASED AT THE TIME OF THE COMPLAINT. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THAT THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. A REVIEW OF MANUFACTURING RECORDS INDICATE THE SOFTWARE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS. A REVIEW OF PRIOR ESCALATION ACTIONS WAS PERFORMED AND FOUND NO ACTIONS THAT ARE APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. THIS ISSUE WILL BE CONTINUOUSLY MONITORED THROUGH COMPLAINT INVESTIGATION AND POST MARKET SURVEILLANCE. BASED ON THE INVESTIGATION, NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, UPON ENTERING THE PLANNING SCREEN IN A CORI ASSISTED LAB, THE GRAPHICS WERE OFF AND THIS CONTINUED ONTO THE GAP ASSESSMENT SCREEN. THEY WERE STILL ABLE TO COLLECT AND SEEMED MORE OF A VISUAL GLITCH. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160351 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown