BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2874454 · Received December 14, 2012

    Report

    Report Number
    6000034-2012-02365
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    March 12, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, THE DEVICE IS UNAVAILABLE FOR ANALYSIS. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT SURGERY TO ACCESS THE PREVIOUSLY IMPLANTED SLEEPER DEVICE ON (B)(6) 2013. THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (DATE NOT REPORTED), RESULTING IN FIXTURE LOSS. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A 90894

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention