BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2900557 · Received January 7, 2013

    Report

    Report Number
    6000034-2013-00014
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 25, 2012
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION ON (B)(6) 2012, RESULTING IN FIXTURE LOSS. THE PATIENT WAS FIT WITH A NEW ABUTMENT ONTO AN EXISTING SLEEPER SITE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7437 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention