BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITANIUM PALATAL EXPANDER

    MDR report key: 961747 · Received April 5, 2007

    Report

    Report Number
    2081322-2007-00001
    Event Type
    Malfunction
    Date Received
    April 5, 2007
    Date of Event
    December 27, 2006
    Report Date
    April 4, 2007
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    DYJ
    PMA / PMN Number
    k923218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS ANALYZED AND EVIDENCE OF BRITTLE FRACTURE WAS CONFIRMED. EXTENSIVE ENGINEERING ANALYSIS OF SIMILAR MALFUNCTIONS IN THE SAME TIME FRAME THAT THIS DEVICE MANUFACTURED CONCLUSIVELY DETERMINED THAT THE MOST PROBABLE CAUSE OF THE DEVICE MALFUNCTION IS LIKELY DUE TO A DECREASE IN THE DUCTILITY AND ELONGATION PROPERTIES OF THE ORTHOLOY ARM AS-RECEIVED FROM THE VENDOR. WHEN THE WIRE IS TOO HARD, BRITTLE FRACTURE CAN OCCUR. EXCESSIVE PRACTITIONER MANIPULATION (BENDING) TO FIT THE PATIENT CAN FURTHER INCREASE FRACTURE PROBABILITY. THIS DEVICE WAS PRODUCED IN AUGUST 2005, INSTALLED IN 2006, AND FAILED ABOUT 2 MONTHS LATER. CORRECTIVE ACTION: TO INCREASE DUCTILITY OF THE WIRE AND PREVENT BRITTLE FRACTURE OF DEVICES DELIVERED TO CUSTOMERS, THE FOLLOWING ACTIONS HAVE BEEN IMPLEMENTED BY ORTHO ORGANIZERS, INC. TWO PROOF-TESTING STEPS HAVE BEEN ADDED TO THE MANUFACTURING PROCESS TO IDENTIFY AND SCREEN ANY POTENTIALLY BRITTLE APPLIANCES PRIOR TO SHIPMENT. THE ORTHOLOY WIRE ARMS ARE ANNEALED AT ORTHO ORGANIZERS PRIOR TO ASSEMBLY TO ENSURE SUFFICIENT DUCTILITY AND ELONGATION PROPERTIES. TENSILE STRENGTH AND ELONGATION SPECIFICATIONS HAVE BEEN REVISED FOR THE SUPPLIED ORTHOLOY WIRE ARMS. THESE DEVICES HAVE BEEN MARKETED FOR OVER 10 YEARS. THE FAILURE RATE ASSOCIATED WITH THE ORTHOLOY ARM IS AN EVENT WITH A LOW OCCURRENCE RATE (LESS THAN 0.02%).

    Description of Event or Problem · 1

    IN 2007, ORTHO ORGANIZERS RECEIVED A COMPLAINT REPORT FROM DR. DOCTOR INSTALLED A 101-768 SIZE 40 NITANIUM PALATAL EXPANDER IN HIS PATIENT IN 2006. HIS PATIENT REPORTED THAT WHEN SHE WOKE ON THE MORNING OF APPROX TWO MONTHS LATER, THE LEFT ARM (WIRE) OF THE DEVICE HAD BROKEN OFF AND WAS MISSING. THE DOCTOR COULD NOT CONFIRM THE PATINET'S REPORT AND NOTED THAT THE PATIENT DISLIKED THE DEVICE AND COMPLAINED ABOUT DISCOMFORT FROM INITIAL INSTALLATION. IT IS POSSIBLE THAT THE PATIENT INGESTED (SWALLOWED) THE MISSING WIRE SECTION, ALTHOUGH THERE IS NO CONCLUSIVE EVIDENCE SHE DID. THE DOCTOR REMOVED THE REMAINING PORTION OF THE BROKEN DEVICE AT THAT TIME, BUT DID NOT INSTALL A NEW DEVICE DUE TO THE PATIENT'S COMPLAINT ABOUT DISCOMFORT. THE DOCTOR REPORTED THE MALFUNCTION ON MARCH 7TH. HE FURTHER REPORTS THAT THERE WAS NO MEDICAL INTERVENTION AND THERE HAS BEEN NO INJURY OR SYMPTOMS OF ANY ADVERSE IMPACT ON THE PATIENT'S HEALTH IN THE 3 MONTHS SINCE THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITANIUM PALATAL EXPANDER ORTHODONTIC INTRAORAL DEVICE DYJ ORTHO ORGANIZERS, INC. 101-768 560212C05

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR