BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2200232 · Received August 11, 2011

    Report

    Report Number
    6000034-2011-00591
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 28, 2011
    Report Date
    September 30, 2011
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT REPORTED THAT THE PROCESSOR BECAME HOT TO THE TOUCH WITH DEVICE USE. IT HAS BEEN REQUESTED THAT THE DEVICE BE REMOVED FROM SERVICE AND RETURNED FOR ANALYSIS. THERE WERE NO ALLEGATIONS OF PATIENT INJURY.

    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 21 YR Required Intervention