BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMX SPECTRA ST SYR HV A3

    MDR report key: 23720057 · Received December 4, 2025

    Report

    Report Number
    8010638-2025-00012
    Event Type
    Injury
    Date Received
    December 4, 2025
    Report Date
    December 4, 2025
    Manufacturer
    DENTSPLY DETREY GMBH
    Product Code
    EBC
    UDI-DI
    D0106424751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT CERAMX SPECTRA ST SYR HV A3 THAT WAS USED IN TREATMENT, SOME FILLINGS IN A FEW PATIENTS HAVE SOFTENED AND CAN BE REMOVED WITH A HARD INSTRUMENT. WHILE OTHER FILLINGS WITH THE SAME MATERIAL REMAIN UNAFFECTED. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156696 CERAMX SPECTRA ST SYR HV A3 SEALANT, PIT AND FISSURE, AND CONDITIONER EBC DENTSPLY DETREY GMBH UNK D0106424751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown