BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 15189619 · Received August 9, 2022

    Report

    Report Number
    6000034-2022-02307
    Event Type
    Injury
    Date Received
    August 9, 2022
    Report Date
    July 19, 2022
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON AUGUST 09, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988063 NI COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention