BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS PLUS ELECTRONIC TOOL KIT

    MDR report key: 25183278 · Received May 15, 2026

    Report

    Report Number
    3014334038-2026-00034
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 15, 2026
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K181902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRONIC TOOL KIT WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED, HOWEVER, POTENTIAL ROOT CAUSE INCLUDES, MAGNETIC CENTERLINE NOT CENTERED ON PHYSICAL CENTER OF MAGNETS OR DEVICE MISHANDLING. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    2 OF 2 REPORTS (SAME EVENT/DIFFERENT PRODUCTS). OTHER MFT REPORT NUMBER: 3013886523-2026-00116. A PHYSICIAN REPORTED A CERTAS VALVE WAS PLACED ON (B)(6) 2025. THE PHYSICIAN EXPERIENCED ISSUES CHECKING THE VALVE SETTING AND PROGRAMMING IT WITH THE ELECTRONIC PROGRAMMER. WHEN ATTEMPTING TO ADJUST THE VALVE, THE ELECTRONIC PROGRAMMER APPEARED TO BE STUCK BETWEEN SETTINGS (2 AND 3 OR 3 AND 4). ON (B)(6) 2026, THE PHYSICIAN ATTEMPTED TO ADJUST THE VALVE TO A SETTING OF 4; HOWEVER, WHEN THE VALVE WAS REMOVED AND THE SETTING WAS CHECKED, IT WAS FOUND TO BE SET AT 5. THE ISSUE MAY HAVE BEEN RELATED TO THE CERTAS VALVE OR THE ELECTRONIC PROGRAMMER USED TO CONFIRM AND CHANGE THE SETTING. OUT OF CAUTION AND TO ADDRESS THE PATIENT¿S CONCERN, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522906 CERTAS PLUS ELECTRONIC TOOL KIT INTERNAL CSF DRAINAGE JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1