BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BL, Ø 4.1MM RC, SLA® 10MM, TIZR, NTP

    MDR report key: 8985010 · Received September 10, 2019

    Report

    Report Number
    0001222315-2019-01772
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    April 1, 2019
    Report Date
    September 9, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031706959
    PMA / PMN Number
    K150938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    "FIED." PATIENT PRESENTED WITH INADEQUATE BONE QUALITY / QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THE PATIENT EXPERIENCED THE FOLLOWING AT THE TIME OF EVENT: MOBILITY AND ABSCESS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778746 BL, Ø 4.1MM RC, SLA® 10MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG TC584 07630031706959

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention