BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMI ROBOTIC NAVIGATION SYSTEM

    MDR report key: 14464166 · Received May 20, 2022

    Report

    Report Number
    3015537048-2022-00002
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 20, 2022
    Report Date
    May 20, 2022
    Manufacturer
    FUSION ROBOTICS, LLC
    Product Code
    OLO
    UDI-DI
    00850026574340
    PMA / PMN Number
    K202184
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE PRELIMINARY ASSESSMENT DETERMINED THAT THE SYSTEM LIKELY FUNCTIONED AS INTENDED AND THE SCREW POSITIONING ISSUE COULD HAVE BEEN ATTRIBUTED TO USE OF A THIRD PARTY DRILL GUIDE WITH THE REMI SYSTEM (AND IN THE CASE OF THE L4 SCREW, IT WAS REVISED DURING THE ORIGINAL PROCEDURE WITHOUT THE REMI SYSTEM AND STILL ENDED UP IN A LESS THAN IDEAL LOCATION). WHILE THE SYSTEM WAS USED WITHOUT CONNECTION OF THE CAMERA TO A PSIS PIN, THERE IS NO INDICATION THAT THIS CAUSED OR CONTRIBUTED TO THE ISSUE AND IS JUST NOTED AS AN OFF LABEL USE OF THE SYSTEM.

    Description of Event or Problem · 0

    ON 21-APR-2022 ACCELUS WAS MADE AWARE OF A COMPLAINT ON THE REMI ROBOTIC NAVIGATION SYSTEM THAT OCCURRED DURING AN INITIAL 3-LEVEL PEDICLE SCREW FIXATION PROCEDURE ON (B)(6) 2022. IT WAS REPORTED THAT ON INTRA-OPERATIVE IMAGING THE SURGEON CONFIRMED THAT THE LEFT L4 SCREW WAS MISPLACED. THE SCREW WAS REMOVED AND REPLACED WITHOUT USING THE REMI SYSTEM. POSTOPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL LEG PAIN. UPON IMAGING REVIEW, IT WAS NOTED THAT THE LEFT L4 SCREW WAS MEDIALIZED. IMAGING ALSO SHOWED INFERIOR (A LOWER DOWN POSITION) PEDICLE SCREW PLACEMENT OF ALL SCREWS IN THE CONSTRUCT. THE SURGEON REPORTED THAT AT THE TIME OF THE SURGERY HE FELT THE PLACING OF THE LEFT L4 SCREW FELT "OFF" EVEN AFTER HE REPLACED IT AND ADDITIONALLY NOTED FIGHTING SOFT TISSUE ON PLACEMENT OF ALL 6 SCREWS IN THE CONSTRUCT. DURING THE INITIAL SURGERY THE SURGEON USED A DRILL GUIDE PROVIDED BY A THIRD PARTY. THE SURGEON REPORTED THAT HE NOW BELIEVED THAT THE LACK OF TEETH ON THE DRILL GUIDE DID NOT ALLOW IT TO SEAT WELL ON THE BONE CAUSING SKIVE AND THE RESULTING SCREW MISPLACEMENT. IT WAS ALSO REPORTED THAT THE SYSTEM WAS USED WITHOUT CONNECTION OF THE CAMERA TO A PSIS PIN AS INDICATED IN THE REMI INSTRUCTIONS FOR USE, HOWEVER, THERE APPEARS TO BE NO LINK TO THIS OFF LABEL USE AND THE RESULTING PLACEMENT ISSUES. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE AND REPLACE ALL THE SCREWS. NO ADDITIONAL PATIENT HARM WAS REPORTED AS A RESULT OF THE REVISION SURGERY. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520543 REMI ROBOTIC NAVIGATION SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO FUSION ROBOTICS, LLC PN-001 00850026574340

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention