BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIX ANKER

    MDR report key: 789252 · Received November 21, 2006

    Report

    Report Number
    8031010-2006-00543
    Event Type
    Malfunction
    Date Received
    November 21, 2006
    Report Date
    October 24, 2006
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO INDICATION THAT PATIENT INJURY OCCURRED, THERE HAVE BEEN PREVIOUS REPORTS OF THIS MALFUNCTION THAT NECESSITATED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. FURTHER INFORMATION PERTAINING TO OUTCOME OF THIS EVENT WILL BE REPORTED IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RADIX ANKER POST SEPARATED. OUTCOME OF THE EVENT IS NOT KNOWN AS OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN