BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP. STANDARD PLUS Ø 3.3 RN 8.0 MM

    MDR report key: 9073569 · Received September 16, 2019

    Report

    Report Number
    0009613348-2019-01775
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    March 28, 2019
    Report Date
    September 16, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031700957
    PMA / PMN Number
    K033922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)96) 2010 IN FDI 36 OF THE PATIENT'S MOUTH. ON (B)(6) 2019, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867160 IMP. STANDARD PLUS Ø 3.3 RN 8.0 MM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG X1348 07630031700957

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention