BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 5100575 · Received September 24, 2015

    Report

    Report Number
    6000034-2015-01886
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    June 23, 2015
    Report Date
    August 31, 2015
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A KELOID AT THE ABUTMENT SITE. SUBSEQUENTLY ON (B)(6), 2015, THE KELOID WAS EXCISED AND THE DEVICE WAS EXPLANTED. DURING THE SAME PROCEDURE, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630492 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A 139396

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention