BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRTS SML SGA VLV

    MDR report key: 25183279 · Received May 15, 2026

    Report

    Report Number
    3013886523-2026-00116
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 15, 2026
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K223330
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    1 OF 2 REPORTS (SAME EVENT/DIFFERENT PRODUCTS). OTHER MFT REPORT NUMBER: 3014334038-2026-00034 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. ACCORDING TO REPORTER: "THE PRODUCT NUMBER FOR THE VALVE IS EITHER 828814PL OR 828815PL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522907 CRTS SML SGA VLV INTERNAL CSF DRAINAGE JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1