BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEDSTROEM FILE

    MDR report key: 3080715 · Received April 9, 2013

    Report

    Report Number
    9611053-2013-00005
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 18, 2013
    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. (B)(4)) TO PRECLUDE INJURY OR ILLNESS THAT WOULD NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE 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. ACTUAL DEVICE WAS DISCARDED. UNUSED FILES FROM SAME PACKAGE WERE RETURNED AND EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT HEDSTROEM FILE SEPARATED DURING USE. AS OF THIS MDR EVALUATION, THE SEPARATED PIECE IS STILL IN THE TOOTH AND THE PT IS PLANNING TO RETURN FOR FURTHER TREATMENT AT THE DENTAL PRACTICE BECAUSE THEY ARE ALLERGIC TO THE FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144762 HEDSTROEM FILE EKS DENTSPLY VDW GMBH VDW031132

    Patients

    Seq Age Sex Outcome Treatment
    1