BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIX ANKER

    MDR report key: 1509104 · Received October 6, 2009

    Report

    Report Number
    8031010-2009-00136
    Event Type
    Malfunction
    Date Received
    October 6, 2009
    Date of Event
    August 15, 2009
    Report Date
    September 9, 2009
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO 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. THEREFORE, THIS EVENT IS REPORTABLE PER 21 CEF PART 803.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RADIX ANKER POST FRACTURED APPROXIMATELY 29 MONTHS AFTER PLACEMENT; THE SEPARATED PIECE WAS RETRIEVED WITHOUT INJURY.

    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