BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERLINE

    MDR report key: 10492060 · Received September 3, 2020

    Report

    Report Number
    3005503242-2020-00133
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    March 9, 2020
    Report Date
    September 2, 2020
    Manufacturer
    DENTIUM USA
    Product Code
    DZE
    UDI-DI
    D755FX4010SWC0
    PMA / PMN Number
    K160965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    C081420-03 SUMMARY MEMO.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE AROUND 4 MONTHS AFTER PLACEMENT SURGERY. THE PATIENT HAS HISTORY OF DIABETES AND HYPERTENSION. BONE QUALITY WAS TYPE III AND ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS GOOD. DURING THE SURGERY, PERIODONTAL DISEASE AND BONE RESORPTION WAS OBSERVED. THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956527 SUPERLINE DENTAL IMPLANT DZE DENTIUM USA FX4010SWC G15OB520S D755FX4010SWC0

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention