BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERELASTIC REGULAR FORCE NITI ARCHWIRES

    MDR report key: 3553376 · Received December 20, 2013

    Report

    Report Number
    2939494-2013-00001
    Event Type
    Injury
    Date Received
    December 20, 2013
    Date of Event
    December 6, 2013
    Report Date
    December 20, 2013
    Manufacturer
    HIGHLAND METALS, INC.
    Product Code
    DZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SIX CUSTOMERS IN THE USA KNOWN TO HAVE RECEIVED (B)(4), LOT 41679 ((B)(4)PACKS IN TOTAL SENT). THESE CUSTOMERS WERE SENT A FIELD SAFETY NOTICE ON 2013-12-13 VIA FAX OR EMAIL INFORMING THEM TO CHECK THE PRODUCT RECEIVED TO DETERMINE IF IT CONTAINS THE WRONG PRODUCT. THE DOCTOR HAS BEEN GIVEN THE OPTION TO KEEP THE PRODUCT, OR RETURN TO HIGHLAND METALS, INC FOR A REFUND. DISTRIBUTORS MUST CONTACT EACH OF THEIR CUSTOMERS THAT MAY HAVE RECEIVED THE PRODUCT TO INFORM THEM OF THE INCIDENT AND FOR THEM TO TAKE THE SAME ACTION.

    Description of Event or Problem · 1

    A CUSTOMER IN THE USA RETURNED A PACKAGE OF NITI ORTHODONTIC WIRES, PRODUCT (B)(4), LOT 41679 TO HIGHLAND METALS INC. THE CUSTOMER INDICATED THAT THE PACKAGE CONTAINED .016" NATURAL UPPER FORM ORTHODONTIC ARCHWIRES, NOT .016" NATURAL LOWER FORM ARCHWIRE AS STATED ON THE LABEL. THE ARCHWIRE IS MARKED WITH AN INK MIDLINE - THE MIDLINE SHOULD BE A RED COLOR FOR LOWER ARCHWIRES BUT IN THIS CASE WERE BLACK COLOR USED FOR UPPER ARCHWIRES. THIS IS EASILY IDENTIFIABLE BY THE ASSISTANT AND DOCTOR. THE WIRES HAD NOT BEEN USED BY THE DOCTOR ON ANY PATIENT AS IT WAS NOTICED WHEN THE ASSISTANT UNLOADING THE ARCHWIRES ONTO THE TRAY FOR USE BY THE DOCTOR. THE WIRE WAS RECEIVED BY HIGHLAND METALS INC ON (B)(4) 2013 AND IT WAS CONFIRMED TO CONTAIN .016" NATURAL UPPER FORM NITI ARCHWIRES. THE LABEL WAS FOR .016" NATURAL LOWER FORM NITI ARCHWIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669424 SUPERELASTIC REGULAR FORCE NITI ARCHWIRES WIRE, ORTHODONTIC DZC HIGHLAND METALS, INC. .016 NATURAL LOWER 41679

    Patients

    Seq Age Sex Outcome Treatment
    1 Other