BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3033552 · Received April 3, 2013

    Report

    Report Number
    6000034-2013-00615
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    August 1, 2012
    Report Date
    March 26, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE IN (B)(6) 2012, AND AGAIN IN (B)(6) 2013 TO REMOVE EXCESS SKIN OVERGROWTH. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135934 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92130

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention