BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HESTROEM FILE

    MDR report key: 2873589 · Received November 14, 2012

    Report

    Report Number
    9611053-2012-00004
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 19, 2012
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    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. JAMES GUTMANN) 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 803. THE DEVICE WAS EVALUATED AND NO MANUFACTURING DEFECT COULD BE FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT A HEDSTROEM FILE SEPARATED AND THE DOCTOR WAS GOING TO ATTEMPT RETRIEVAL. HOWEVER, ON (B)(6) 2012, IT WAS REPORTED THAT THE SEPARATED PIECE WAS NOT RETRIEVED AND WAS INCORPORATE INTO THE FILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HESTROEM FILE EKS DENTSPLY VDW GMBH 005414

    Patients

    Seq Age Sex Outcome Treatment
    1