BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3234070 · Received July 18, 2013

    Report

    Report Number
    6000034-2013-01327
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    July 13, 2013
    Report Date
    July 18, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS PLACED UNDER GENERAL AND LOCAL ANESTHESIA IN AN OR TO REPLACE THE ABUTMENT. REVISION OF TISSUE AROUND THE IMPLANT SIDE HAS BEEN PERFORMED DURING THE SAME SURGERY.THIS REPORT IS FILED DECEMBER 6, 2013. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THE 9MM ABUTMENT WITH A 10MM ABUTMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6), 2013.THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334055 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92346 96349

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention