BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2914531 · Received January 14, 2013

    Report

    Report Number
    6000034-2013-00095
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE SURGEON, THE PATIENT WAS ADMINISTERED LOCAL ANESTHETIC PRIOR TO SURGERY, (B)(6) 2013, TO EXCISE SKIN OVERGROWTH AROUND THE ABUTMENT. THIS REPORT IS FILED (B)(4) 2013. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013. DURING THE PROCEDURE, THE ABUTMENT WAS REPLACED WITH A LONGER MODEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED 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
    21036 FLANGE FIXTURE AND ABUTMENT LXB, PRODCUT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R