BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATTERSON BRAND CONTRA ANGLE REAMER

    MDR report key: 743480 · Received June 30, 2005

    Report

    Report Number
    9611053-2005-00250
    Event Type
    Malfunction
    Date Received
    June 30, 2005
    Date of Event
    May 26, 2005
    Report Date
    May 31, 2005
    Manufacturer
    PATTERSON DENTAL CO.
    Product Code
    EKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS INCIDENT THERE WAS NO REPORT OF INJURY TO THE PT. HOWEVER, AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS (THOUGH INADVISABLE PER EXPERT OPINION PROVIDED BY DR 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. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. IT WAS REPORTED THAT THE REAMER WAS USED IN A 1/4 TURN HANDPIECE, A POSSIBLE CONTRIBUTING FACTOR IN THE EVENT; THE REAMER INVOLVED IN THIS EVENT IS INDICATED FOR USE IN A 360 DEGREES HANDPIECE. PLEASE NOTE THAT THE SAME PT IS INVOLVED IN THIS EVENT AND THE EVENT DOCUMENTED UNDER REPORT NUMBER 9611053-2005-00249.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REAMER SEPARATED IN THE CANAL DURING A PROCEDURE. THE SEPARATED PIECE WAS RETRIEVED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATTERSON BRAND CONTRA ANGLE REAMER ENDODONTIC REAMER EKP PATTERSON DENTAL CO. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR UNKNOWN 1/4 TURN HANDPIECE