BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7D SURGICAL SYSTEM

    MDR report key: 9752209 · Received February 25, 2020

    Report

    Report Number
    3012098629-2020-00001
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    January 30, 2020
    Report Date
    January 30, 2020
    Manufacturer
    7D SURGICAL, INC.
    Product Code
    OLO
    UDI-DI
    00628341520379
    PMA / PMN Number
    K183276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANONYMIZED SYSTEM LOG FILES FROM THE REPORTED CASE WAS RETRIEVED BY 7D SURGICAL FOR DETERMINING ROOT CAUSE OF THE EVENT. BASED ON THE ANALYSIS OF THE SESSION LOGS, IT WAS DETERMINED THAT THIS EVENT WAS NOT CAUSED BY A MALFUNCTION OF THE 7D SURGICAL SYSTEM AND IS LIKELY ATTRIBUTED TO ONE OF TWO ROOT CAUSES: (1) DEFLECTION OF THE PEDICLE ACCESS KIT (PAK, PN: MP6001-7D) BEFORE OR DURING CANNULATION OR (2) MOTION OF THE REFERENCE FRAME RELATIVE TO THE SPINE. WHILE ADVANCING THE PAK THROUGH THE SOFT TISSUE FOR THE RIGHT L5 CANNULATION, NAVIGATION SHOWED THAT THE TRAJECTORY WAS INFERIOR TO THE PEDICLE. WITHOUT REMOVING THE PAK FROM THE TISSUE, THE USER REDIRECTED THE PAK TO THE WHAT APPEARS TO BE ALIGNED WITH THE PEDICLE. IT IS POSSIBLE THAT DURING THIS REDIRECTION, THAT THE SHAFT OF THE PAK WAS DEFLECTED RELATIVE TO THE MARKER ARRAY OF THE PAK. THIS WOULD RESULT IN THE NAVIGATION VIEW ON THE 7D SURGICAL SYSTEM DISPLAYING A DIFFERENT TRAJECTORY THAN THE PHYSICAL POSITION OF THE TOOL INSIDE THE PATIENT. ACCURATE NAVIGATION OF THE PAK NEEDLE REQUIRES THE USER NOT TO APPLY FORCES TO THE PAK THAT WOULD RESULT IN BENDING OF THE SHAFT RELATIVE TO THE ARRAY. ADDITIONALLY, THE USER DID NOT VERIFY REGISTRATION ACCURACY BETWEEN CANNULATIONS SO IT CANNOT BE RULED OUT THAT THERE WAS MOTION OF THE REFERENCE FRAME RELATIVE TO THE SPINE. THE SYSTEM AND SOFTWARE FUNCTIONED AS DESIGNED. THIS WAS A USE ERROR RELATED EVENT.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED L4-L5 PEDICLE SCREW IMPLANTATION IN THE SPINE USING THE PEDICLE ACCESS KIT (PAK, PN: MP6001-7D). THE SURGEON PERFORMED AN INTRAOPERATIVE FLUOROSCOPY AND NOTED THAT THE RIGHT L5 SCREW SEEMED INFERIOR TO THE TARGET POSITION BUT DEEMED IT ACCEPTABLE. THE SURGEON CONTINUED AND COMPLETED THE SURGERY. THE PATIENT COMPLAINED OF PAIN ON (B)(6) 2020. FOLLOWING A REVIEW OF THE POST-OPERATIVE CT SCAN, THE RIGHT SIDE SCREW OF L5 WAS IDENTIFIED AS A CONCERN. HOWEVER, THE SURGEON PROCEEDED TO REMOVE BOTH THE RIGHT-SIDE L4 AND L5 SCREWS PERMANENTLY. ON (B)(6) 2020 THE PHYSICIAN INFORMED 7D SURGICAL THAT THE PATIENT WAS DOING WELL FOLLOWING THE SECOND SURGERY PERFORMED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215374 7D SURGICAL SYSTEM COMPUTER-ASSISTED SURGICAL DEVICE OLO 7D SURGICAL, INC. 10-0001 N/A 00628341520379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention