BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERCON YO ML A2 DISK 98 18

    MDR report key: 24742185 · Received March 31, 2026

    Report

    Report Number
    9681199-2026-00002
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 31, 2026
    Manufacturer
    DEGUDENT GMBH
    Product Code
    EIH
    UDI-DI
    EDD153661052180
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A CERCON YO ML A3 DISK 98 18 USED IN TREATMENT, FRACTURE OF THE BRIDGE 10 DAYS AFTER INTEGRATION. THE PATIENT ALSO EXPERIENCED A CUT ON THEIR TONGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614842 CERCON YO ML A2 DISK 98 18 POWDER, PORCELAIN EIH DEGUDENT GMBH 18061030 EDD153661052180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown