BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIVE S PLUS IMPL D3.4/L13

    MDR report key: 8883230 · Received August 12, 2019

    Report

    Report Number
    9612468-2019-02326
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    April 30, 2019
    Report Date
    August 8, 2019
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    PMA / PMN Number
    K073075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    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. REF: REVOCATION OF EXEMPTION (ASR) #E1997021 AND E1997026. REPORT LATE DUE TO ASR TO INDIVIDUAL REPORTING TRANSITION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679208 XIVE S PLUS IMPL D3.4/L13 IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention