BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3192900 · Received June 27, 2013

    Report

    Report Number
    6000034-2013-01120
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 13, 2013
    Report Date
    January 2, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED JANUARY 31, 2014.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION ON (B)(6), 2013, RESULTING IN FIXTURE LOSS. THE PATIENT WAS GIVEN A LOCAL ANESTHETIC INJECTION (TYPE AND AMOUNT NOT REPORTED) TO FACILITATE FIXTURE/ABUTMENT REMOVAL AND TO CLOSE THE SITE WITH SUTURES. THERE ARE PLANS TO REPLACE THE LOST FIXTURE, BUT IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6), 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294821 FLANGE FIXTURE AND ABUTMENT PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 132685

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention