BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXT MODULAR REAMER HEAD

    MDR report key: 1030807 · Received April 17, 2008

    Report

    Report Number
    2242816-2008-00052
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 23, 2008
    Report Date
    April 2, 2008
    Manufacturer
    EBI
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 8MM REAMER WAS NOT ABLE TO REAM THE FULL LENGTH OF THE CANAL AS INTENDED. THE REAMER WAS ONLY ABLE TO REAM HALF WAY DOWN AND THEN STOPPED. AN ADD'L REAMER WAS AVAILABLE AND WAS USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXT MODULAR REAMER HEAD HTO EBI

    Patients

    Seq Age Sex Outcome Treatment
    1