BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SP Ø 4.1MM RN, SLA® 10MM, TI, LOXIM

    MDR report key: 15616747 · Received October 17, 2022

    Report

    Report Number
    0001222315-2022-21999
    Event Type
    Injury
    Date Received
    October 17, 2022
    Date of Event
    August 30, 2022
    Report Date
    October 17, 2022
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031719614
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 7. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE AND RIDGE AUGMENTATION. ON 2022-08-30, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV, POOR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2939989 SP Ø 4.1MM RN, SLA® 10MM, TI, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLA Titanium TL RZ288 07630031719614

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention