BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7D SURGICAL SYSTEM

    MDR report key: 11902847 · Received May 28, 2021

    Report

    Report Number
    3012098629-2021-00001
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 3, 2021
    Manufacturer
    7D SURGICAL, INC.
    Product Code
    OLO
    UDI-DI
    00628341520379
    PMA / PMN Number
    K162375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    7D SURGICAL WAS ABLE TO RECEIVE THE ANONYMIZED SYSTEM LOG FILES AND THE POST-OPERATIVE CT SCAN FROM THE INITIAL SURGERY. AN INVESTIGATION WAS PERFORMED BY 7D SURGICAL IN ORDER TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. BASED ON THE RESULTS OF THE INVESTIGATION, 7D SURGICAL WAS UNABLE TO DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE 7D SURGICAL NAVIGATION SYSTEM WAS USED TO CANNULATE L3-L5 BILATERALLY DURING A POSTERIOR FUSION SURGERY. AFTER REGISTERING SEGMENTALLY TO L3, THE SURGEON VERIFIED AND ACCEPTED THE REGISTRATION AND PLACED 2 SCREWS. THE RIGHT L3 SCREW APPEARED IN AN APPROPRIATE POSITION ON THE INTRAOPERATIVE FLUOROSCOPY SHOT AND WAS CONFIRMED BY THE SURGEON. UPON REVIEWING THE PATIENT'S POST-OPERATIVE CT, THE RIGHT L3 SCREW WAS IDENTIFIED AS A CONCERN WITH A LATERAL BREACH. THE SURGEON PERFORMED A FOLLOW-UP REVISION SURGERY TO CORRECT THE RIGHT L3 SCREW. THE SURGEON REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801334 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