BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETM WEINGARDT PLIER

    MDR report key: 509822 · Received February 2, 2004

    Report

    Report Number
    2016150-2004-00001
    Event Type
    Injury
    Date Received
    February 2, 2004
    Date of Event
    December 11, 2003
    Manufacturer
    ORMCO CORP.
    Product Code
    JEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2003, A CLINICIAN WAS USING THE ETM WEINGARDT PLIER TO CRIMP A STOP ON A TITANIUM WIRE. WHEN THE PLIER WAS SQUEEZED THE TIP OF THE PLIER FRACTURED OFF AND HIT AN ADJACENT TOOTH, #7, CAUSING AN ENAMEL FRACTURE OF THE INCISAL EDGE. THE PT WAS REFERRED TO THEIR GENERAL PRACTITIONER FOR A COMPOSITE RESTORATION OF THE AFFECTED TOOTH. THE RESTORATION WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO LOSS OF VITALITY AND NO ENDODONTIC TREATMENT WAS REQUIRED. THE GENERAL PRACTITIONER CONFIRMED THAT ORTHODONTIC TREATMENT COULD BE CONTINUED. THE PT HAS NOT HAD ANY FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETM WEINGARDT PLIER ORTHODONTIC PLIER JEX ORMCO CORP. E-158 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other