BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSIBLE TITANIUM PARTIAL PROSTHESIS

    MDR report key: 3963687 · Received April 3, 2014

    Report

    Report Number
    9616949-2014-00001
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 28, 2014
    Manufacturer
    AUDIO TECHNOLOGIES SRL
    Product Code
    ETB
    PMA / PMN Number
    K001142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR HAS REPORTED AN EVENT THAT HAPPENED DURING AN AUDIO PROSTHESIS, EXPLANTED FROM A PATIENT. HERE BELOW THE REPORT FROM THE DISTRIBUTOR: "CUSTOMER STATES THEY HAVE EXPLANTED (B)(6) 2014 AND FOUND PRODUCT TO BE BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203201 EXTENSIBLE TITANIUM PARTIAL PROSTHESIS EXTENSIBLE PARTIAL PROSTHESIS ETB AUDIO TECHNOLOGIES SRL PAP 07.64 0212

    Patients

    Seq Age Sex Outcome Treatment
    1