BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNT CONNECTOR TITANIUM STRL

    MDR report key: 18301565 · Received December 11, 2023

    Report

    Report Number
    3013886523-2023-00434
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    November 22, 2023
    Report Date
    January 25, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780518877
    PMA / PMN Number
    K053350
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    STRAIGHT CONNECTOR (B)(6) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS NOTED. ROOT CAUSE ANALYSIS - NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE, AT THE TIME OF INVESTIGATION NO FUNCTION ISSUES WERE NOTED.

    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

    N/A.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPOT NUMBER 3013886523-2023-00433. A PHYSICIAN REPORTED A HAKIM VALVE (ID 823834) WAS IMPLANTED IN 2019 VIA VENTRICULOPERITONEAL (VP) SHUNT WITH SETTING 90 MMH2O. THE VALVE WAS USED WITH THE STRAIGHT CONNECTOR (ID 823053). ON NOVEMBER 22, 2023, THE VALVE SETTING WAS CHANGED TO 30 MMH2O. HOWEVER, DUE TO THE RESULT OF PATENCY CHECK, THE SUSPICION OF BLOCKAGE WAS CONFIRMED. THEREFORE, THE HAKIM VALVE AND CONNECTOR WERE REMOVED AND REPLACED ON (B)(6), 2023. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT HAD SIGNS AND SYMPTOMS DUE TO OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044024 SHUNT CONNECTOR TITANIUM STRL CONNECTORS JXG INTEGRA LIFESCIENCES MANSFIELD 10381780518877

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male HAKIM VALVE (B)(6).