BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOFFELMIRE RETAINER

    MDR report key: 596510 · Received April 21, 2005

    Report

    Report Number
    MW1035291
    Event Type
    Malfunction
    Date Received
    April 21, 2005
    Report Date
    April 21, 2005
    Manufacturer
    SULLIVAN-SCHEIN DENTAL
    Product Code
    JEP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE ANGLED TOFFELMIRE RETAINER HAS POOR QUALITY AND ERRATIC MACHINING THAT CAUSED THE MATRIX BAND RETENTION SLOT TO INADEQUATELY TIGHTEN THE MATRIX BAND AND CAUSES METAL FATIGUE AND FRACTURE OF THE RETAINING ELEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOFFELMIRE RETAINER RETAINER JEP SULLIVAN-SCHEIN DENTAL 100-0436 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *