BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUSTAR DENTAL CHAIR

    MDR report key: 23213539 · Received October 3, 2025

    Report

    Report Number
    1017522-2025-00002
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    July 24, 2024
    Report Date
    October 3, 2025
    Manufacturer
    KAVO DENTAL TECHNOLOGIES, LLC
    Product Code
    NRU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHAIR WAS NOT RETURNED FOR EVALUATION. HOWEVER, BASED ON COMMUNICATION FROM THE INITIAL REPORTER TO PELTON TECHNICAL SERVICE THE CHAIR FAILED AS A RESULT OF IMPROPER MAINTENANCE. THROUGH TROUBLESHOOTING BY PELTON TECHNICAL SERVICE REPLACEMENT PARTS WERE PROVIDED TO REPAIR THE CHAIR TO MANUFACTURER SPECIFICATIONS. THIS CONCLUDES THE INVESTIGATION.

    Description of Event or Problem · 0

    THE ALLEGED INCIDENT WAS REPORTED BY MR. (B)(6) LEGAL REPRESENTATIVE AS FOLLOWS: THE DENTAL HYGIENIST ADJUSTED THE CHAIR SO THAT MR. (B)(6) WAS SITTING UPRIGHT, WHEN THE BACK SUPPORT OF THE CHAIR SUDDENLY COLLAPSED CAUSING THE CHAIR TO WHIP BACKWARDS. MR. (B)(6) WAS SEEN AND EVALUATED BY THE EMERGENCY DEPARTMENT STAFF AT (B)(6) HOSPITAL. THIS EVALUATION INCLUDED AN X-RAY OF HIS LUMBAR AND SACRAL SPINE, A CT SCAN OF HIS HEAD AND BRAIN WITHOUT CONTRAST, AND A CT SCAN OF HIS CERVICAL SPINE. THE EMERGENCY DEPARTMENT STAFF CONCLUDED THAT, AS A RESULT OF THE ACCIDENT, MR. (B)(6) SUFFERED A CLOSED HEAD INJURY, ACUTE CERVICAL STRAIN, AND ACUTE TRAUMATIC LOW BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588512 NUSTAR DENTAL CHAIR DENTAL CHAIR NRU KAVO DENTAL TECHNOLOGIES, LLC DC1700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O