BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3914374 · Received July 3, 2014

    Report

    Report Number
    6000034-2014-00918
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 DEVELOPED AN INFECTION AT THE IMPLANT SITE. SUBSEQUENTLY ON (B)(6) 2014; THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS (DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390575 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 131261

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention