BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE CLYNDRICAL

    MDR report key: 24712230 · Received March 30, 2026

    Report

    Report Number
    3013886523-2026-00063
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 7, 2026
    Report Date
    May 29, 2026
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780519188
    PMA / PMN Number
    K221840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    A FACILITY REPORTED A HAKIM VALVE (ID 823115) HAD CEREBROSPINAL FLUID LEAKAGE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330590 PROG VALVE CLYNDRICAL INTERNAL CSF DRAINAGE JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 7396733 10381780519188

    Patients

    Seq Age Sex Outcome Treatment
    1