BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2851678 · Received November 29, 2012

    Report

    Report Number
    6000034-2012-02275
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 15, 2012
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE (DATE NOT REPORTED) TO REMOVE AN OVERGROWTH OF SKIN TISSUE AROUND THE ABUTMENT AND HAD A KENALOG INJECTION. THIS REPORT IS FILED (B)(4) 2012. IMPLANTED DEVICE REMAINS..

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE (DATE NOT REPORTED) TO REMOVE AN OVERGROWTH OF SKIN TISSUE AROUND THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention