BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2912133 · Received January 11, 2013

    Report

    Report Number
    6000034-2013-00002
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    April 1, 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

    PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE SURGERY TO EXCISE SKIN TISSUE PRIOR TO EXPLANTATION (DATE NOT REPORTED). THE PATIENT WAS ADMINISTERED ORAL AND IV ANTIBIOTICS (DATE, TYPE, AND AMOUNTS NOT REPORTED).THIS REPORT IS FILED (B)(6), 2013. (B)(4): IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) DUE TO ONGOING STAPH INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6) 2013. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16293 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention