BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3519729 · Received December 13, 2013

    Report

    Report Number
    6000034-2013-02136
    Event Type
    Injury
    Date Received
    December 13, 2013
    Report Date
    March 24, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CORRECTION: THE PMA IS K984162; NOT K955713 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED APRIL 30, 2014, DEVICE CURRENTLY UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (DATE NOT REPORTED) RESULTING IN FIXTURE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653246 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A 9496

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention