BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2130604 · Received June 16, 2011

    Report

    Report Number
    6000034-2011-00409
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 12, 2011
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION AND SUBSEQUENT FIXTURE LOSS. THE FIXTURE IS NOT AVAILABLE FOR ANALYSIS. THE PATIENT WAS REIMPLANTED WITH ANOTHER FIXTURE (DATE NOT REPORTED).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention