BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3914254 · Received July 3, 2014

    Report

    Report Number
    6000034-2014-00933
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 12, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION IN 2011 (MONTH AND DAY NOT REPORTED) RESULTING IN FIXTURE LOSS. THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE ON (B)(6), 2011. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391192 FLANGE FIXTURE AND ABUTMENT LXB: PRODUCT CODE LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention