BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1962549 · Received January 18, 2011

    Report

    Report Number
    6000034-2011-00028
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    February 2, 2009
    Report Date
    December 13, 2012
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED (B)(4) 2012.

    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 LACK OF OSSEOINTEGRATION AND SUBSEQUENT FIXTURE LOSS. THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE ON (B)(6) 2010, (DATE NOT SPECIFIED) WITH THE SECOND STAGE OF THE PROCEDURE OCCURRING ON (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention