BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø4.1MM RC, SLA® 8MM, TIZR, LOXIM

    MDR report key: 8976931 · Received September 9, 2019

    Report

    Report Number
    0001222315-2019-01181
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    March 22, 2019
    Report Date
    September 9, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707123
    PMA / PMN Number
    K150938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    RER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770736 BLT Ø4.1MM RC, SLA® 8MM, TIZR, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG TN314 07630031707123

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention