BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRATECH IMPL EV 4.2S 11MM OS

    MDR report key: 11884700 · Received May 26, 2021

    Report

    Report Number
    9612468-2021-30499
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    October 22, 2019
    Report Date
    May 20, 2021
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784531 ASTRATECH IMPL EV 4.2S 11MM OS IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention