BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENOVO SPACE MAINTAINER BAND CHAIRSIDE SPACE MAINTAINER

    MDR report key: 15348312 · Received September 1, 2022

    Report

    Report Number
    MW5111849
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    August 30, 2022
    Report Date
    August 30, 2022
    Manufacturer
    DENOVO DENTAL, INC.
    Product Code
    ECM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS CHILD HAD A PREFABRICATED DENTAL SPACE MAINTAINER CEMENTED ON HER LOWER RIGHT SECOND PRIMARY MOLAR IN (B)(6) 2021. AT HER SECOND RECALL EXAMINATION IT WAS DETERMINED THAT THE PREFABRICATED SPACE MAINTAINER'S SOLDER JOINT HAD FAILED AND THE CHILD HAD LOST PART OF THE DEVICE (SOLDERED TUBE AND NARROW WIRE). I HAVE SEEN MULTIPLE REPORTS FROM COLLEAGUES ON SIMILAR DEVICE FAILURES WITH THE SAME MANUFACTURER. THERE IS AN INCREASED RISK OF POSSIBLE SWALLOWING OR ASPIRATION AS A RESULT OF THIS DEFECT. I AM NOT AWARE OF ANY INSTANCE OF ASPIRATION OR SWALLOWING, BUT I AM CONCERNED ABOUT THE POSSIBILITY. FDA SAFETY REPORT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301354 DENOVO SPACE MAINTAINER BAND CHAIRSIDE SPACE MAINTAINER BAND, PREFORMED, ORTHODONTIC ECM DENOVO DENTAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female Required Intervention