BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø4.1MM RC, SLACTIVE® 10MM, TIZR, NTP

    MDR report key: 9668422 · Received February 4, 2020

    Report

    Report Number
    0009613348-2020-07367
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    January 10, 2020
    Report Date
    February 4, 2020
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707031
    PMA / PMN Number
    K140878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)96) 2019 IN FDI 16. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. 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
    131745 BLT Ø4.1MM RC, SLACTIVE® 10MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLActive Roxolid BL XZ237 07630031707031

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention