BEUDAMED
    FDA Adverse Event Death Summary report: N

    7D SURGICAL SYSTEM

    MDR report key: 13122551 · Received December 30, 2021

    Report

    Report Number
    3012098629-2021-00002
    Event Type
    Death
    Date Received
    December 30, 2021
    Date of Event
    December 8, 2021
    Report Date
    December 8, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A 7D SURGICAL REPRESENTATIVE VISITED THE SITE AND A COMPLETE SYSTEM PERFORMANCE CHECK WAS PERFORMED, RESULTS INDICATED THAT THE SYSTEM WAS OPERATING WITHIN NORMAL SPECIFICATIONS. RESULTS FROM THE 7D SURGICAL INVESTIGATION DETERMINED THAT THE DEVICE DID NOT MALFUNCTION. BASED ON A REVIEW OF THE ANONYMIZED NAVIGATION LOG FILES RETRIEVED FROM THE SYSTEM THERE WERE NO ISSUES WITH THE REGISTRATION, VERIFICATION OR THE NAVIGATION DURING THE CASE. A REVIEW OF THE NAVIGATION DATA FEED INDICATED THAT MULTIPLE CANNULATIONS WERE MADE IN THE SACRUM WHILE ATTEMPTING TO GET THE PROPER S2AI TRAJECTORY. THE MOST LIKELY ROOT CAUSE OF THE INJURY WAS THAT WHEN TAPPING WITH 8.5MM UNNAVIGATED TAP THAT THE TAP FOLLOWED A PRIOR CANNULATION AND SKIVED AT THE SI JOINT AND LACERATED AN ILIAC ARTERY. IT IS IMPORTANT TO NOTE THAT THE DEVICE HAS BEEN EVALUATED AT THE CUSTOMER SITE AND WAS FOUND TO OPERATE IN ACCORDANCE WITH PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 0

    7D SURGICAL RECEIVED INFORMATION REGARDING NAVIGATION BEING USED IN AN OPEN T4-PELVIS FUSION. T4- S1 SCREWS WERE ALL PLACED ACCURATELY WITH THE AID OF THE 7D SYSTEM. WHEN PREPARING TO PLACE THE LEFT S2AI SCREW THE SURGEON REGISTERED, VERIFIED NAVIGATION ACCURACY AND CANNULATED THE LEFT S2AI TRAJECTORY USING THE NAVIGATED LUMBAR AWL AND PEDICLE PROBE. USING AN UNNAVIGATED BALL TIP FEELER, THE SURGEON CHECKED THE CANNULATION AND COMMENTED THAT HE FELT THE FLOOR. THE SURGEON THEN USED AN UNNAVIGATED 8.5MM TAP TO TAP THE CANNULATION. HOWEVER, WHEN THE TAP WAS REMOVED THE SURGICAL CAVITY BEGAN TO FILL WITH BLOOD. THE SURGEON RECHECKED THE TAPPED CANNULATION ONCE THE BLEEDING HAD SLOWED AND STATED HE COULD NO LONGER FEEL THE FLOOR MEANING THAT THE TOOL HAD BREACHED THE BONE. THE CASE WAS STOPPED, AND THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY. THE ROOT CAUSE OF THE BLEEDING WAS DUE TO A LACERATION OF AN ILIAC ARTERY. UNFORTUNATELY, THE PATIENT SUBSEQUENTLY PASSED AWAY FROM THE INJURY. BOTH THE SURGEON AND THE HOSPITAL CONSIDER THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE USE OF THE 7D SURGICAL SYSTEM AND THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018697 7D SURGICAL SYSTEM COMPUTER-ASSISTED SURGICAL DEVICE OLO 7D SURGICAL, INC. 10-0001-03 00628341520379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death