BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1862539 · Received October 8, 2010

    Report

    Report Number
    6000034-2010-00647
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 28, 2010
    Report Date
    December 7, 2010
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT SUSTAINED A BLOW TO THE HEAD, RESULTING IN A LOSS OF OSSEOINTEGRATION AND SUBSEQUENT FIXTURE LOSS. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT, (B)(6) 2010.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER MODULE POWER CONNECTION WAS BROKEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention