BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2912139 · Received January 11, 2013

    Report

    Report Number
    6000034-2013-00063
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    January 24, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT PATIENT IDENTIFIER IS (B)(6); NOT (B)(6) AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4) 2013. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AROUND THE ABUTMENT. THE PATIENT UNDERWENT REVISION SURGERY TO EXCISE THE EXCESS SKIN (DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16295 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 Hospitalization| R