BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERLINE

    MDR report key: 15820989 · Received November 17, 2022

    Report

    Report Number
    3005503242-2022-00109
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    September 28, 2022
    Report Date
    November 17, 2022
    Manufacturer
    DENTIUM USA
    Product Code
    DZE
    UDI-DI
    D755FX3612SWC0
    PMA / PMN Number
    K160965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE SEE ATTACHED SUMMARY MEMO.

    Description of Event or Problem · 0

    THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE APPROXIMATELY 4 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED BONE RESORPTION AND PERI-IMPLANTITIS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAD A RIDGE AUGMENTATION PROCEDURE (GBR) DONE ON TOOTH #6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2774349 SUPERLINE DENTAL IMPLANT DZE DENTIUM USA FX3612SWC A11MB724S D755FX3612SWC0

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention