BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAMON COPPER NITI WIRE

    MDR report key: 1160385 · Received September 16, 2008

    Report

    Report Number
    2016150-2008-00082
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Report Date
    August 18, 2008
    Manufacturer
    ORMCO CORPORATION
    Product Code
    DZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 IN 2008, (MDR #2016150-2008-00001: 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

    ON AUGUST 18, 2008 A DOCTOR INFORMED ORMCO CORPORATION THAT HE HAD DAMON CUNITI WIRE BREAKAGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other