BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 5982304 · Received September 27, 2016

    Report

    Report Number
    6000034-2016-01864
    Event Type
    Injury
    Date Received
    September 27, 2016
    Report Date
    September 5, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE (DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630377 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB BIA200 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention