BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2882873 · Received December 21, 2012

    Report

    Report Number
    6000034-2012-02389
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 5, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED NOVEMBER 7, 2013. DEVICE NOT AVAILABLE FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE ON (B)(6), 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention