BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 14579755 · Received June 2, 2022

    Report

    Report Number
    3010266064-2022-00428
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 10, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RE-ASSESSED FOR REPORTABILITY AND IT HAS BEEN DETERMINED THAT THE PRODUCT (HIP7) INVOLVED IS FROM THE THIRD PARTY MANUFACTURER BRAINLAB INC. THE LEGAL MANUFACTURER, BRAINLAB INC., WILL REVIEW THE EVENT AND DETERMINE REPORTABILITY AND REPORT TO NATIONAL COMPETENT AUTHORITIES IF/WHEN DEEMED NECESSARY. THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. THIS EVENT HAS BEEN RE-ASSESSED FOR REPORTABILITY AND IT HAS BEEN DETERMINED THAT THE PRODUCT (HIP7) INVOLVED IS FROM THE THIRD PARTY MANUFACTURER BRAINLAB INC. THE LEGAL MANUFACTURER, BRAINLAB INC., WILL REVIEW THE EVENT AND DETERMINE REPORTABILITY AND REPORT TO NATIONAL COMPETENT AUTHORITIES IF/WHEN DEEMED NECESSARY. THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER REGISTRATION OF THE FOSSA IN A CORI ASSISTED THA SURGERY, THEY RECEIVED THE ASIS DISTANCE ERROR. THEY HAD TO CREATE A NEW CASE AND NOT IMPORT THE X-RAY TO MOVE FORWARD. THE SURGERY WAS COMPLETED WITH MANUAL INSTRUMENTATIONS AND STANDARD CHECKS WITHOUT SIGNIFICANT DELAYS. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554932 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention