BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMX SPECTRA ST SYR HV A2

    MDR report key: 23720212 · Received December 4, 2025

    Report

    Report Number
    8010638-2025-00014
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Report Date
    December 4, 2025
    Manufacturer
    DENTSPLY DETREY GMBH
    Product Code
    EBC
    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
    2455427 CERAMX SPECTRA ST SYR HV A2 SEALANT, PIT AND FISSURE, AND CONDITIONER EBC DENTSPLY DETREY GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown