BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3241507 · Received July 22, 2013

    Report

    Report Number
    6000034-2013-01360
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 19, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED GRANULATION TISSUE AT THE IMPLANT SITE, WHICH WAS SURGICALLY REMOVED UNDER GENERAL ANESTHESIA ON (B)(6), 2013. DURING THE PROCEDURE, THE ABUTMENT WAS REMOVED AND A LONGER ABUTMENT WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341004 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 90305

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention