BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAPLINK

    MDR report key: 10840618 · Received November 13, 2020

    Report

    Report Number
    2016150-2020-00005
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Report Date
    November 13, 2020
    Manufacturer
    ORMCO CORPORATION
    Product Code
    DZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALLEGED THAT A MALFUNCTION TO SNAPLINK OCCURED, AND THE PATIENT WAS INJURED. THE PATIENT HAS RECOVERED, AND NO SERIOUS INJURY WITH THIS INCIDENT.

    Description of Event or Problem · 1

    SNAPLINK GATE WOULD OPEN, AND WIRE POKED THE PATIENT IN THE CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305927 SNAPLINK SNAPLINK DZD ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other