BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BL, Ø 4.8MM RC, SLA® 12MM, TIZR, NTP

    MDR report key: 9525327 · Received December 27, 2019

    Report

    Report Number
    0001222315-2019-14685
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 27, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707376
    PMA / PMN Number
    K150938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)96) 2019 IN ADA 27. ON (B)(6) 2011, 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
    1321534 BL, Ø 4.8MM RC, SLA® 12MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG RM249 07630031707376

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention