BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS PLUS INLINE WITH SIPHON

    MDR report key: 18966525 · Received March 24, 2024

    Report

    Report Number
    3013886523-2024-00089
    Event Type
    Injury
    Date Received
    March 24, 2024
    Date of Event
    March 7, 2024
    Report Date
    April 19, 2024
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780521174
    PMA / PMN Number
    K143111
    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.

    Additional Manufacturer Narrative · 0

    THE CERTAS VALVE (ID 828804PL) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-8804PL WITH LOT 7242876, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 7. THE VALVE WAS VISUALLY INSPECTED, THE VALVE DIRTY BY THE BIOLOGICAL DEBRIS. THE SIPHON GUARD WAS DAMAGED, A CUT MARK WAS NOTED ON THE SIPHON GUARD. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR PROGRAMMING AND PRESSURE. THE FLUSH, LEAK, REFLUX AND SIPHON GUARD TESTS COULD NOT BE PERFORMED AS THE SIPHON GUARD WAS DAMAGED. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE VALVE OR ATYPICAL HANDLING, AS NOTED IN THE SURGICAL PROCEDURE PRECAUTIONS SECTION IN INSTRUCTION FOR USE (IFU), SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    Description of Event or Problem · 0

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2024-00091 A FACILITY REPORTED AN ELEVEN YEAR-OLD PATIENT WITH AN EXTENSIVE MEDICAL AND SURGICAL HISTORY PRESENTED WITH NEW SYRINX, UNDERWENT A REDO CHIARI AND SINCE THEY THOUGHT HE WAS OVER SHUNTING FROM HIS CERTAS (UNKNOWN ID-WITHOUT SIPHONGUARD), THEY DECIDED TO TRANSITION HIM TO A SIPHONGUARD ON (B)(6) 2024 ((B)(6)) . THE PATIENT THEN PRESENTED ON (B)(6) 2024, WITH A SUBGALEAL FLUID COLLECTION AND A BROKEN VALVE. WHEN THEY EXCHANGED HIM TO A NEW VALVE, THEY DRILLED A TROUGH FOR THE VALVE IN HIS CALVARIUM, SO NOW THE VALVE SITS IN A WALL OF BONE. HE IS NONVERBAL AUTISTIC AND DOES HAVE SELF-HITTING BEHAVIOR. THEY ARE NOT SURE IF HE BROKE HIS VALVE. THE BROKEN VALVE WAS REMOVED AND REPLACED ON (B)(6) 2024, WITH ANOTHER NEW (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460802 CERTAS PLUS INLINE WITH SIPHON CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 7242876 10381780521174

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Unknown