BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SP Ø 4.1MM RN, SLA® 6MM, TIZR, NTP

    MDR report key: 9040797 · Received September 13, 2019

    Report

    Report Number
    0009613348-2019-29117
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    May 31, 2019
    Report Date
    September 13, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031718730
    PMA / PMN Number
    K150938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)96) 2019 IN FDI 16 OF THE PATIENT'S MOUTH. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844529 SP Ø 4.1MM RN, SLA® 6MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG 07630031718730

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention