BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI300 IMPLANT 4 MM

    MDR report key: 10446432 · Received August 24, 2020

    Report

    Report Number
    6000034-2020-02186
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 3, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON AUGUST 25, 2020.

    Description of Event or Problem · 1

    PER THE SURGEON, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. TREATMENT WITH TOPICAL STEROIDS AND ANTIBIOTICS WERE UNSUCCESSFUL. SUBSEQUENTLY, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE EXCESS SKIN ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905259 BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92129 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention