BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAMON COPPER NITI WIRE

    MDR report key: 851730 · Received May 17, 2007

    Report

    Report Number
    2016150-2007-00035
    Event Type
    Malfunction
    Date Received
    May 17, 2007
    Date of Event
    April 1, 2007
    Report Date
    April 20, 2007
    Manufacturer
    ORMCO CORP.
    Product Code
    DZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO REPORTED INJURIES ASSOCIATED WITH THIS INCIDENT. HOWEVER, DUE TO THE PRIOR SUBMISSION OF A REPORTABLE INCIDENT ON THE DAMON COPPER NITI WIRE ON JUNE 15, 2005 (MDR # 2016150-2005-00002: MALFUNCTION WHICH REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE) THIS INCIDENT IS REPORTABLE. THIS INCIDENT FALLS UNDER THE FDA PRESUMPTION THIS TYPE OF MALFUNCTION IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IN APRIL 2007, A DR INFORMED ORMCO CORP, THAT HE HAD DAMON CUNITI WIRE BREAKAGES. THERE ARE NO REPORTED INJURIES ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAMON COPPER NITI WIRE WIRE, ORTHODONTIC DZC ORMCO CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other