BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE ST 4MM

    MDR report key: 9748422 · Received February 24, 2020

    Report

    Report Number
    6000034-2020-00501
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    January 3, 2020
    Report Date
    January 31, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON FEBRUARY 25, 2020.

    Description of Event or Problem · 1

    PER THE SURGEON, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION OF THE IMPLANT. A RE-IMPLANTATION IS PLANNED (DATE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209403 FLANGE FIXTURE ST 4MM COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 90432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention