BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDO CROWN-FESTOONING SCS

    MDR report key: 2117133 · Received May 19, 2011

    Report

    Report Number
    2523190-2011-00031
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    INTEGRA, YORK - IMILTEX
    Product Code
    ELZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    FACILITY INITIALLY REPORTED THE ITEMS HAVE BROKEN TIPS. NO PT INJURY. ON (B)(6) 2011, CUSTOMER REPORTS THAT THIS DEVICE IS USED TO MANIPULATE CROWNS AND THE DOCTOR IS CONCERNED THAT THERE IS POTENTIAL FOR THE TIPS TO BE SWALLOWED WHEN THEY BREAK OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDO CROWN-FESTOONING SCS M9 - ORAL-MAXILLO ELZ INTEGRA, YORK - IMILTEX

    Patients

    Seq Age Sex Outcome Treatment
    1