BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMI ROBOTIC NAVIGATION SYSTEM

    MDR report key: 16356078 · Received February 10, 2023

    Report

    Report Number
    3015537048-2023-00001
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    January 12, 2023
    Report Date
    February 10, 2023
    Manufacturer
    FUSION ROBOTICS, LLC
    Product Code
    OLO
    UDI-DI
    00850026574340
    PMA / PMN Number
    K202184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THE DEVICE WAS EVALUATED IN THE FIELD BY A QUALIFIED ACCELUS REPRESENTATIVE AND FOUND TO BE FULLY FUNCTIONING.

    Description of Event or Problem · 0

    ON 11-JAN-2023 ACCELUS WAS MADE AWARE OF A COMPLAINT ON THE REMI ROBOTIC NAVIGATION SYSTEM. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE AND REPLACE PEDICLE SCREWS THAT WERE PLACED INFERIOR TO THE PEDICLE DURING THE INITIAL SURGERY. THE INITIAL SURGERY WAS A LEFT L4/L5 ENDO TLIF, WITH LINESIDER MIS AND REMI WITH O-ARM REGISTRATION. IT WAS REPORTED THAT DURING THE INITIAL SURGERY THE SYSTEM WAS USED WITHOUT CONNECTION OF THE CAMERA TO A PSIS PIN AS INDICATED IN THE REMI INSTRUCTIONS FOR USE. IT WAS REPORTED THAT AFTER THE INITIAL SURGERY THE PATIENT EXPERIENCED LEFT SIDE PAIN UPON WEIGHT BEARING AND A CT SCAN PERFORMED TO FIND THE LEFT L4 AND LEFT L5 PEDICLE SCREWS WERE INFERIOR TO THE PEDICLES BY A SIMILAR DISTANCE (ROUGHLY 5 MM). THE PATIENT WAS THEN TAKEN BACK TO THE OR 3 DAYS LATER AND REVISION OF BOTH THE LEFT L4 AND L5 PEDICLE SCREWS WAS PERFORMED USING STEALTH NAVIGATION AND GUIDEWIRES WITH LINESIDER MIS SCREWS. THE REVISION SURGERY WAS COMPLETED WITHOUT ISSUE AND NO ADDITIONAL PATIENT HARM WAS REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54808 REMI ROBOTIC NAVIGATION SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO FUSION ROBOTICS, LLC PN-001 00850026574340

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention