BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSFORCE

    MDR report key: 10693787 · Received October 16, 2020

    Report

    Report Number
    2081322-2019-00002
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    November 1, 2019
    Report Date
    December 23, 2019
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    EJF
    UDI-DI
    00190707060008
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO ORGANIZERS, INC. BECAME AWARE ON DECEMBER 6TH, 2019 OF AN INCIDENT IN (B)(6) WHERE AN ARM OF A TRANSFORCE APPLIANCE WAS BROKEN OFF AND SWALLOWED BY A PATIENT WHILST SLEEPING. X-RAY CONFIRMED THAT THE ROD WAS SWALLOWED. ORTHO ORGANIZERS RECEIVED ADVERSE EVENT REVIEW EMPLOYEE/PATIENT QUESTIONNAIRE COMPLETED BY MARKUS WAND (NOT A HEALTHCARE PROFESSIONAL). THE BROKEN APPLIANCE WILL NATURALLY PASS THROUGH THE PATIENT'S BODY. GERMAN DISTRIBUTOR (NOT HEALTHCARE PROFESSIONAL) MR. WAND ASSUMED THAT REOCCURRENCE OF SAME MALFUNCTION COULD RESULT IN SERIOUS INJURY. HOWEVER, PAST SIMILAR SITUATIONS HAS RESULTED WITH PATIENT PASSING THE DEVICE COMPONENT NATURALLY WITHOUT NEED FOR MEDICAL INTERVENTION. SUBSEQUENT FOLLOW-UP WITH PATIENT DETERMINED THAT THE PATIENT DID NATURALLY PASS THE DEVICE AND IS DOING FINE. INVESTIGATION OF THE DEVICE IS NOT POSSIBLE IN THIS CASE.

    Description of Event or Problem · 1

    INCIDENCE OCCURRED IN (B)(6) WHERE AN ARM OF A TRANSFORCE APPLIANCE (ORTHODONTIC ATTACHMENT) WAS BROKEN OFF OF THE TOOTH AND SWALLOWED BY THE PATIENT WHILST SLEEPING. X-RAY CONFIRMED THAT THE ROD WAS SWALLOWED AND IS STILL IN THE PATIENT'S BODY. COMPLAINT SENT TO ORTHO ORGANIZERS, INC. ON DECEMBER 6TH 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155041 TRANSFORCE ORTHODONTIC APPLIANCE EJF ORTHO ORGANIZERS, INC. 424-532 912883 00190707060008

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other