BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3234863 · Received July 18, 2013

    Report

    Report Number
    6000034-2013-01329
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    July 16, 2013
    Report Date
    August 19, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE SURGEON, THE PATIENT UNDERWENT A PROCEDURE, UNDER LOCAL ANESTHESIA IN (B)(6) 2013 (SPECIFIC DATE NOT REPORTED) TO REPLACE THE ABUTMENT. CORRECTION: THE CORRECT CATALOG NUMBER IS 93335; NOT 93331 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED OCTOBER 23, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED RECURRENT INFECTIONS AT THE IMPLANT SITE FOR WHICH ORAL ANTIBIOTICS (TYPE AND DOSAGE NOT REPORTED) WERE PRESCRIBED. THE ABUTMENT WAS REMOVED TO FACILITATE TREATMENT. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333471 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A 132686

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention