BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2930586 · Received January 28, 2013

    Report

    Report Number
    6000034-2013-00155
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 17, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 A SKIN FLAP INFECTION AT THE IMPLANT SITE AND SUBSEQUENTLY SKIN FLAP NECROSIS. THE PATIENT HAS BEEN PRESCRIBED ORAL ANTIBIOTICS (TYPE AND AMOUNT NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36773 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 122311

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention