BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA300 IMPLANT 4MM W ABUTMENT 9MM

    MDR report key: 10999430 · Received December 13, 2020

    Report

    Report Number
    6000034-2020-03437
    Event Type
    Injury
    Date Received
    December 13, 2020
    Report Date
    November 24, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    UDI-DI
    09321502019767
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON DECEMBER 14, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN ISSUES AT THE IMPLANT SITE, AND WAS TREATED WITH A STEROID OINTMENT (DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464711 BIA300 IMPLANT 4MM W ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92346 COH1306447 09321502019767

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention