BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRTS SM IL SG VLV ONLY

    MDR report key: 16263955 · Received January 30, 2023

    Report

    Report Number
    3013886523-2023-00021
    Event Type
    Injury
    Date Received
    January 30, 2023
    Report Date
    April 27, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780529378
    PMA / PMN Number
    K182265
    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 828814PL) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-8814PL WITH LOT 6160771, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 5. THE VALVE WAS VISUALLY INSPECTED; THE ROTATION CONSTRUCT WAS IN THE UP POSITION AND A TEAR/CUT IN THE SILICONE HOUSING AROUND THE SIPHON GUARD WAS NOTED. THE VALVE WAS TESTED FOR PROGRAMMING; THE VALVE FAILED THE TEST. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK TESTED; LEAKED FROM THE DAMAGED SILICONE HOUSING. THE VALVE COULD NOT BE REFLUX TESTED, DUE TO DAMAGED SILICONE HOUSING. THE VALVE PASSED THE TEST FOR, OCCLUSION, SIPHON GUARD AND PRESSURE. THE SIPHON GUARD WAS VISUALLY INSPECTED, MARK WERE NOTED ON THE SIPHON GUARD. THE VALVE WAS DRIED. THE SIPHON GUARD WAS REMOVED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION. WHEN DISMANTLED THE ROTATING CONSTRUCT REMAINED FIXED TO THE UPPER CASING, STRESS MARKS WERE NOTED IN THE BUMP MARK IN THE UPPER CASING AND THE SPRING HAS BEEN BENT. ROOT CAUSE - THE ROOT CAUSE FOR THE BUMP MARK IN THE TOP OF THE VALVE CASING IS DUE TO THE VALVE RECEIVING A KNOCK. THE ROOT CAUSE FOR THE ROTATING CONSTRUCT STUCK IN THE UPPER POSITION AND THE BENT SPRING IS DUE TO THE VALVE RECEIVING A KNOCK. THE ROOT CAUSE FOR THE PROGRAMING ISSUE REPORTED BY THE CUSTOMER IS DUE TO THE VALVE RECEIVING A KNOCK. THE ROOT CAUSE FOR THE CUT/TEAR IN THE SILICONE HOUSING IS PROBABLY DUE TO A SHARP OR POINTED OBJECT, OR HANDLING, AS NOTED IN THE IFU SILICONE HAS A LOW CUT/TEAR RESISTANCE, AND THE ROOT CAUSE FOR THE MARKS IN THE SIPHON GUARD IS DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SIPHON GUARD.

    Description of Event or Problem · 0

    A FACILITY REPORTED A CERTAS VALVE (ID 828814PL) WAS IMPLANTED ABOUT 6 MONTHS AGO TO TREAT HYDROCEPHALUS. THE VALVE WON'T REPROGRAM TO DIFFERENT SETTING. SEVERAL ATTEMPTS WERE MADE TO REPROGRAM TO DIFFERENT SETTING WITH MULTIPLE PROGRAMMERS WITH NO SUCCESS. THE PATIENT WAS EXPERIENCING IRRITABILITY AND FATIGUE (ALSO HAD EAR INFECTION. THEREFORE, THE VALVE NEEDED TO BE REVISED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5082 CRTS SM IL SG VLV ONLY CERTAS PLUS SMALL & RA W/SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 828814PL 6160771 10381780529378

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown