BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIX ANKER

    MDR report key: 1057161 · Received June 5, 2008

    Report

    Report Number
    8031010-2008-00047
    Event Type
    Malfunction
    Date Received
    June 5, 2008
    Report Date
    May 8, 2008
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO INDICATION PT INJURY RESULTED OR THAT INTERVENTION WAS REQUIRED, THERE HAVE BEEN PREVIOUS REPORTS OF THIS MALFUNCTION THT NECESSITATED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY. THE DEVICE WAS RETURNED, VISUALLY INSPECTED, AND FOUND TO HAVE SEPARATED JUST UNDER THE HEAD; NO VISUAL DEFECTS WERE NOTED. THE DIAMETER WAS ALSO MEASURED AND FOUND TO BE IN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RADIX-ANKER POST SEPARATED APPROXIMATELY THREE YEARS AFTER PLACEMENT; A TEMPORARY RESTORATION WAS PLACED AS A RESULT. THERE IS NO INDICATION THAT PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIX ANKER ELR DENTSPLY MAILLEFER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK