BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE

    MDR report key: 12858248 · Received November 22, 2021

    Report

    Report Number
    6000034-2021-03478
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    September 21, 2021
    Report Date
    October 27, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOV 23, 2021.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH. A SKIN REVISION WAS PERFORMED UNDER A GENERAL ANAESTHETIC ON (B)(6) 2021 TO REMOVE THE SKIN OVERGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755529 BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92132

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention