BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2933987 · Received January 30, 2013

    Report

    Report Number
    6000034-2013-00174
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 21, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SOFT TISSUE PROBLEMS AROUND THE ABUTMENT DUE TO POSSIBLE ALLERGIC REACTION. TREATMENT WITH TOPICAL CREAM (DATE & TYPE NOT REPORTED) WAS UNSUCCESSFUL. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40520 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention