BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NVIEW S1 WITH NAV OPTION

    MDR report key: 22959494 · Received September 3, 2025

    Report

    Report Number
    3033279142-2025-00002
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 5, 2025
    Report Date
    August 22, 2025
    Manufacturer
    NVIEW MEDICAL
    Product Code
    OWB
    PMA / PMN Number
    K221344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH EMAIL COMMUNICATION WITH THE SURGEON, IT WAS DETERMINED THAT WHILE THERE IS INFORMATION THAT REASONABLY SUGGSTS 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 ABUNDUNCE OF CAUTION, THIS EVENT WILL BE REPORTED.

    Description of Event or Problem · 0

    DURING A POSTERIOR SPINAL FUSION ON A SMALL PEDIATRIC PATIENT (BMI 10) WITH OSTEOPENIA, THE CASE WAS STARTED WITH THE AID OF THE NVIEW S1 WITH NAV OPTION. DURING THE PROCEDURE, IT WAS FOUND THAT THE BONE WAS TOO SOFT AND SMALL TO ATTACH THE PATIENT REFERENCE IN THE LUMBAR AND THORACIC SPINE, SO THE SURGEON OPTED TO SWITCH TO A TRADITIONAL FLUOROSCOPIC C-ARM WITHOUT NAVIGATION. TOWARD THE END OF THE CASE, THE PATIENT WENT INTO RESPIRATOY ARREST. THE NVIEW S1 WITH NAV OPTION WAS NOT BEING USED DURING THIS PORTION OF THE PROCEDURE. THERE WAS NO LONG TERM HARM REPORTED, NOR WAS A PROLONGATION OF HOSPITALIZATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450039 NVIEW S1 WITH NAV OPTION NVIEW S1 WITH NAV OPTION OWB NVIEW MEDICAL S1

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Required Intervention