BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BL, Ø 4.8MM RC, SLACTIVE 12MM, TIZR, NTP

    MDR report key: 9441307 · Received December 9, 2019

    Report

    Report Number
    0001222315-2019-12402
    Event Type
    Injury
    Date Received
    December 9, 2019
    Date of Event
    September 30, 2019
    Report Date
    December 9, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707284
    PMA / PMN Number
    K121131
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 14. ON (B)96) 2019, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, MOBILITY AND INCREASED SENSITIVITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232636 BL, Ø 4.8MM RC, SLACTIVE 12MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG RE416 07630031707284

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention