BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NVIEW S1 WITH NAV OPTION

    MDR report key: 22959365 · Received September 3, 2025

    Report

    Report Number
    3033279142-2025-00001
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 21, 2025
    Manufacturer
    NVIEW MEDICAL
    Product Code
    OWB
    PMA / PMN Number
    K221344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH EMAIL COMMUNICATION WITH THE SURGEON, IT WAS DETERMINED THAT WHILE THERE IS INFORMATION THAT REASONABLY SUGGESTS A REPORTABLE EVENT OCCURED, THERE IS NO INFORMATION THAT REASONABLY SUGGESTS THAT THE NVIEW S1 HAS CAUSED OR MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THAT BEING SAID, THERE IS NO WAY TO COMPLETELY RULE OUT THE NVIEW S1 INVOLVEMENT, AND IN AN ABUNDANCE OF CAUTION, THIS EVENT WILL BE REPORTED. WE COMPLETED THE INVESTIGATION AND DID NOT FIND ANY ADDITIONAL INFORMATION THAT COULD REASONABLY SUGGEST THE NVIEW S1 WITH NAV OPTION MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR HAS MALFUNCTIONED AND THIS DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 0

    TWO DAYS AFTER A PEDIATRIC POSTERIOR SPINAL FUSION (T2-T12) USING THE NVIEW S1 WITH NAV OPTION, THE PATIENT LOST MOTORS. THEY WERE PREVIOUSLY RECOVERING WELL. A SECOND SURGERY WAS REQUIRED TO REMOVE HARDWARE AND RESTORE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386934 NVIEW S1 WITH NAV OPTION NVIEW S1 WITH NAV OPTION OWB NVIEW MEDICAL S1

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female Required Intervention