BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR OSIA OSI300 IMPLANT

    MDR report key: 24541700 · Received March 8, 2026

    Report

    Report Number
    6000034-2026-00753
    Event Type
    Injury
    Date Received
    March 8, 2026
    Report Date
    May 9, 2026
    Manufacturer
    COCHLEAR LTD
    Product Code
    PFO
    UDI-DI
    09321502070676
    PMA / PMN Number
    K231204
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CORRECT BRAND NAME, MODEL # AND PMA/510(K) IS COCHLEAR OSIA OSI300 IMPLANT, OSI300 AND K231204; NOT COCHLEAR OSIA OSI200 IMPLANT, OSI200 AND K191921 RESPECTIVELY AS PREVIOUSLY REPORTED IN INITIAL MDR [6000034-2026-00753]. PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2025.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFLAMMATORY REACTION AT THE IMPLANT SITE (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED). IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614632 COCHLEAR OSIA OSI300 IMPLANT COCHLEAR¿ OSIA¿ SYSTEM PFO COCHLEAR LTD OSI300 NA 09321502070676

    Patients

    Seq Age Sex Outcome Treatment
    1