BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2884684 · Received December 24, 2012

    Report

    Report Number
    6000034-2012-02416
    Event Type
    Injury
    Date Received
    December 24, 2012
    Report Date
    February 4, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT REVISION SURGERY IN (B)(6) 2011 (DAY NOT REPORTED) TO CORRECT AN OVERGROWTH OF SKIN TISSUE AT THE IMPLANT SITE. THIS REPORT IS FILED (B)(4), 2013. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED (B)(6) 2011 (DAY NOT REPORTED) AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. DEVICE UNAVAILABLE FOR ANALYSIS. THIS REPORT IS FILED (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY IN 2011 (EXACT DATE NOT REPORTED) TO CORRECT AN OVERGROWTH OF SKIN TISSUE AROUND THE IMPLANT SITE. 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 123371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention