BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2770995 · Received October 3, 2012

    Report

    Report Number
    6000034-2012-01903
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    October 1, 2012
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS IN (B)(6) OF 2012 (EXACT DATE NOT REPORTED), IN ORDER TO TREAT AN INFECTION AROUND THE IMPLANT SITE. THE IMPLANTED DEVICE REMAINS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention