BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE

    MDR report key: 8783610 · Received July 12, 2019

    Report

    Report Number
    6000034-2019-01192
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    June 6, 2019
    Report Date
    June 27, 2019
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE RECIPIENT EXPERIENCED A BONE OVERGROWTH ON THE ABUTMENT. WITH THE RECIPIENT UNDER A GENERAL ANAESTHETIC, AN ABUTMENT CHANGE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. THE ISSUE HAS BEEN RESOLVED WITH MEDICAL/SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580372 BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92132 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention