BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BETA TITANIUM ARCH

    MDR report key: 292173 · Received August 22, 2000

    Report

    Report Number
    2939494-2000-00001
    Event Type
    Malfunction
    Date Received
    August 22, 2000
    Report Date
    August 11, 2000
    Manufacturer
    ACME MONACO
    Product Code
    DZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ALL OF THE BETA TITANIUM THAT WAS SOLD TO FACILITY WAS NOT TESTED TO THEIR SAMPLING PLAN "C=O" TO ANY LEVEL OF ASSURANCE FOR BRITTLESNESS. FACILITY CUSTOMERS AND PTS EXPERIENCED BREAKAGE IN NORMAL USE OF DEVICE. FACILITY WITHDREW ALL PRODUCT FROM MARKET. ACME WILL REPLACE WITH BETTER PRODUCT IF AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BETA TITANIUM ARCH ORTHODONTIC ARCH WIRE DZC ACME MONACO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other