BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1901701 · Received November 17, 2010

    Report

    Report Number
    6000034-2010-00707
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    March 1, 2009
    Report Date
    February 9, 2010
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT HAS A HISTORY OF IMPLANT LOSS AND REIMPLANTATION. THE FIRST IMPLANT LOSS OCCURRED ON (B)(6) 2009 AND THE PATIENT WAS REIMPLANTED ON (B)(6) 2009, WITH THE SECOND STAGE BEING COMPLETED ON (B)(6) 2009. THE SECOND IMPLANT LOSS OCCURRED ON (B)(6) 2010 WHEN THE FIXTURE EXTRUDED AND WAS REMOVED IN THE CLINIC. REIMPLANTATION OCCURRED ON (B)(6) 2010, WITH THE SECOND STAGE BEING COMPLETED ON (B)(6) 2010.

    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 10 YR Required Intervention