BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9034430 · Received September 13, 2019

    Report

    Report Number
    0009613348-2019-07378
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    July 12, 2019
    Report Date
    September 13, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031719614
    PMA / PMN Number
    K033922
    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 46 OF THE PATIENT'S MOUTH. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)96) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. 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
    840249 SP Ø 4.1MM RN, SLA® 10MM, TI, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG TM602 07630031719614

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention