BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø3.3MM NC, SLA® 8MM, TIZR, LOXIM

    MDR report key: 9095084 · Received September 19, 2019

    Report

    Report Number
    0009613348-2019-30037
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    August 27, 2019
    Report Date
    September 19, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031706713
    PMA / PMN Number
    K150938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED 2019-06-21 IN FDI 42. ON 2019-06-21, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886174 BLT Ø3.3MM NC, SLA® 8MM, TIZR, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG VJ813 07630031706713

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention