BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3150092 · Received June 6, 2013

    Report

    Report Number
    6000034-2013-01032
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    August 26, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED NOVEMBER 11, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LACK OF OSSEOINTEGRATION (DATE NOT REPORTED), RESULTING IN FIXTURE LOSS. THERE ARE PLANS TO REPLACE THE LOST FIXTURE, BUT IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250780 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A 131830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention