BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE

    MDR report key: 12858247 · Received November 22, 2021

    Report

    Report Number
    6000034-2021-03477
    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
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer 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
    1755528 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