BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRATECH IMPL EV 4.2S 11MM OS

    MDR report key: 24632686 · Received March 18, 2026

    Report

    Report Number
    3013111692-2026-08674
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    January 16, 2026
    Report Date
    March 18, 2026
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532214271
    PMA / PMN Number
    K120414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    Description of Event or Problem · 0

    CUSTOMER REPORTED AN IMPLANT LOSS - MOBILITY IMPLANT REGION 25 DID NOT HEAL, HAD TO BE REMOVED, IMPRESSION TAKEN BEFOREHAND AT HZA WHERE THE IMPLANT LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689729 ASTRATECH IMPL EV 4.2S 11MM OS IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 526372 07392532214271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention IMPLANT WITH GF.