BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMA DENTAL

    MDR report key: 23714944 · Received December 4, 2025

    Report

    Report Number
    3003444492-2025-00007
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Report Date
    May 7, 2026
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CAPA402 HAS BEEN RAISED TO INVESTIGATE THE NON-CONFORMANCE. A FOLLOW UP REPORT SHALL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN CONCLUDED. ATTACHED IS A PRODUCT SPECIFICATION AND COMPARISION OF THE AFFECTED DEVICES THAT WERE RELEASED. CONTAINMENT ACTIONS: - PLACE BOTH CROUND006RA AND CROUND008RA BURS ON HOLD IN SYSPRO. - COMPLETE - PROVIDE AND COMPARISON OF SPECIFICATIONS BETWEEN CROUND006RA AND CROUND008RA - COMPLETE (ATTACHED). - COMMUNICATION SENT TO AFFECTED CUSTOMERS TO REQUEST THE CUSTOMER TO RETURN THE INCORRECT BURS - COMPLETE

    Description of Event or Problem · 0

    INCORRECT PRODUCT SENT TO THE CUSTOMER (B)(6). INSTEAD OF ISSUING CROUND006RA CROUND008RA WAS ISSUED. THE MRP SYSTEM IS CORRECT BUT AFTER AN INVESTIGATION IT WAS DETERMINED THAT JOB NUMBERS (B)(6). WERE POTENTIALLY MIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348198 PRIMA DENTAL DENTAL BUR EJL PRIMA DENTAL GROUP CROUND006RA DETAILS ATTACHED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown