BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 5655765 · Received May 16, 2016

    Report

    Report Number
    6000034-2016-00929
    Event Type
    Injury
    Date Received
    May 16, 2016
    Date of Event
    April 19, 2016
    Report Date
    April 20, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED MAY 16, 2016. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION ON (B)(6) 2016. RE-IMPLANTATION IS PLANNED; HOWEVER, HAS YET TO OCCUR AS OF THE DATE OF THIS REPORT, MAY 16, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311234 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB BIA200

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention