BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BA400 ABUTMENT 10MM

    MDR report key: 15388667 · Received September 9, 2022

    Report

    Report Number
    6000034-2022-02629
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    August 4, 2022
    Report Date
    August 18, 2022
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT IS SUBMITTED ON SEPTEMBER 09, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC,THE PATIENT EXPERIENCED SOFT TISSUE OVERGROWTH AROUND THE ABUTMENT. THE PATIENT WAS PLACED UNDER MAC ANESTHESIA ON (B)(6) 2022 IN ORDER TO REMOVE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236140 BA400 ABUTMENT 10MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93335 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention