BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S, Ø 3.3MM RN, SLACT. 10MM, TIZR, GEF.

    MDR report key: 9036451 · Received September 13, 2019

    Report

    Report Number
    0009613348-2019-09325
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    June 28, 2019
    Report Date
    September 13, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031715579
    PMA / PMN Number
    K090260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 37 OF THE PATIENT'S MOUTH. DETAILS OF SURGERY: BONE OVERHEATING. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835057 S, Ø 3.3MM RN, SLACT. 10MM, TIZR, GEF. ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG NP820 07630031715579

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention