BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SP Ø 4.1MM RN, SLACTIVE® 12MM, TIZR, NTP

    MDR report key: 13119818 · Received December 30, 2021

    Report

    Report Number
    0001222315-2021-22987
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    November 18, 2021
    Report Date
    December 30, 2021
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031715982
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 13. ON (B)(6) 2021-11-18, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: BLEEDING AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016500 SP Ø 4.1MM RN, SLACTIVE® 12MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLActive Roxolid TL 07630031715982

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention