BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (17-0572) ANK C/X IMPL D8/D7.0/L8(IMPLANTS)

    MDR report key: 11933722 · Received June 3, 2021

    Report

    Report Number
    9612468-2021-29398
    Event Type
    Injury
    Date Received
    June 3, 2021
    Report Date
    May 14, 2021
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
    Product Code
    DZE
    PMA / PMN Number
    K140347
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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
    826030 (17-0572) ANK C/X IMPL D8/D7.0/L8(IMPLANTS) IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention