BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC1335 DENTAL CHAIR

    MDR report key: 12094089 · Received June 30, 2021

    Report

    Report Number
    1017522-2021-00002
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 30, 2021
    Manufacturer
    KAVO DENTAL TECHNOLOGIES, LLC
    Product Code
    NRU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPON THE INITIAL EVALUATION CONDUCTED BY THE ON-SITE DEALER TECHNICIAN, HE WAS ABLE TO IDENTIFY THE PROBLEM AND IMPLEMENT THE CORRECTION ACCORDING TO THE DC1335 INSTALL INSTRUCTIONS. THE DEALER TECHNICIAN PROVIDED INITIAL PHOTOS OF THE PRODUCT MALFUNCTION DETAILING THE PROBLEM, AS WELL AS PHOTOS OF THE CORRECTION TO THE CHAIR. KAVO DENTAL TECHNOLOGIES, LLC REVIEWED ALL PHOTOS PROVIDED BY THE DEALER TECHNICIAN. AFTER FURTHER EVALUATION OF THE PHOTOS, IT HAS BEEN DETERMINED THAT THE SET SCREW WAS NOT PROPERLY INSTALLED, PRIOR TO CORRECTION, ACCORDING TO THE DC1335 INSTALL INSTRUCTIONS. THIS RESULTED IN THE PRODUCT MALFUNCTION; THE SEPARATION OF THE BACK LINK FROM THE BACK PIN AND THE CHAIR BACK TO FALL. THE DC1335 CHAIR INSTALL INSTRUCTIONS STATE TO TIGHTEN THE SET SCREW ON THE BACK LINK SO THAT THE CHAIR IS FIRMLY RETAINED.

    Description of Event or Problem · 1

    THE DEALER TECHNICIAN REPORTED THAT THE CHAIR BACK DROPPED SUDDENLY WITH PATIENT IN CHAIR. THE BACKREST LINK CAME LOOSE, AND BACKREST DROPPED. IT WAS REPORTED THAT THE LINK SET SCREW APPEARED TO BE LOOSE DUE TO WEAR INSIDE LINK. IT WAS ALSO REPORTED THAT THE PATIENT WENT TO A CHIROPRACTOR THE SAME DAY AND IS RECEIVING ONGOING CHIROPRACTIC TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989922 DC1335 DENTAL CHAIR DENTAL CHAIR NRU KAVO DENTAL TECHNOLOGIES, LLC DC1335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other