BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SP, Ø 3.3MM RN, SLACT. 8MM, TIZR, GEF.

    MDR report key: 9047310 · Received September 13, 2019

    Report

    Report Number
    0009613348-2019-16680
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    July 8, 2019
    Report Date
    September 13, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031715630
    PMA / PMN Number
    K090260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2013 IN FDI 22 OF THE PATIENT'S MOUTH. ON (B)(6) 2019, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845461 SP, Ø 3.3MM RN, SLACT. 8MM, TIZR, GEF. ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG CL053 07630031715630

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention