BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SP Ø 3.3MM RN, SLA® 12MM, TI, LOXIM

    MDR report key: 9498716 · Received December 19, 2019

    Report

    Report Number
    0001222315-2019-14466
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    August 1, 2019
    Report Date
    December 19, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031719478
    PMA / PMN Number
    K033922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)96) 2019 IN ADA 26. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288910 SP Ø 3.3MM RN, SLA® 12MM, TI, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG HL853 07630031719478

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention