BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEDSTROEM FILE

    MDR report key: 3063252 · Received February 26, 2013

    Report

    Report Number
    8031010-2013-00003
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 28, 2013
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 21CFR PART 803. ACTUAL FILE USED IN THE EVENT WAS NOT AVAILABLE FOR EVALUATION. UNUSED FILES FROM THE SAME PACKAGE WERE RETURNED AND FOUND TO BE WITHIN SPECIFICATION. ALSO, A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83175 HEDSTROEM FILE EKS DENTSPLY MAILLEFER 1181630

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR