BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1130473 · Received August 20, 2008

    Report

    Report Number
    6000034-2008-00473
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS, AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, IN 2008 (ESTIMATED, DATE NOT REPORTED) THE PT WAS IMPLANTED WITH A PRIMARY AND A SLEEPER FIXTURE. AT APPROX 3 MONTHS LATER, DURING THE SECOND STAGE PROCEDURE, THE PRIMARY FIXTURE CAME OUT. THE SLEEPER FIXTURE WAS WELL INTEGRATED AND THE ABUTMENT WAS ATTACHED TO IT WITHOUT DIFFICULTY. RETURN OF THE FIXTURE AND ADD'L INFO HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLANGE FIXTURE AND ABUTMENT LXB COCHLEAR BONE ANCHORED SOLUTIONS, AB 90430 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention