BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITIFLEX FILE

    MDR report key: 2132401 · Received June 13, 2011

    Report

    Report Number
    8031010-2011-00083
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 24, 2011
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EKS
    PMA / PMN Number
    K951607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS (THOUGH INADVISABLE PER EXPERT OPINION PROVIDED BY DR. (B)(6)) TO PRECLUDE INJURY OR ILLNESS THAT WOULD NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A NITIFLEX FILE SEPARATED; EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION. THERE WAS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITIFLEX FILE EKS DENTSPLY VDW GMBH 0911001536

    Patients

    Seq Age Sex Outcome Treatment
    1