BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2973325 · Received February 21, 2013

    Report

    Report Number
    6000034-2013-00373
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    April 12, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF ABUTMENT FOLLOWED BY BLOOD AND GRANULATION TISSUE AROUND THE IMPLANT SIDE. REVISION SURGERY IS PLANNED: HOWEVER, IT IS UNKNOWN IF THIS HAS ALREADY OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75895 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention