BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1219512 · Received November 3, 2008

    Report

    Report Number
    6000034-2008-00619
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 10, 2008
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS, AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT'S FLANGE FIXTURE FELL OUT. THERE WAS NO OBVIOUS MEDICAL CONDITIONS OR TRAUMA REPORTED. PER THE RETURNED PAPERWORK, THE PT HAD A SKIN INFECTION WHICH CAUSED/CONTRIBUTED TO THE LOSS OF THE IMPLANT. NO FURTHER INFO WAS REPORTED AT THE DATE OF THIS REPORT, NOVEMBER 03, 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLANGE FIXTURE AND ABUTMENT LXB COCHLEAR BONE ANCHORED SOLUTIONS, AB 90480 607431

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention