BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 5X11.5 SELF-TAPPING IMPLANT WITH MOUNT

    MDR report key: 190794 · Received October 8, 1998

    Report

    Report Number
    2184002-1998-00706
    Event Type
    Injury
    Date Received
    October 8, 1998
    Date of Event
    September 2, 1998
    Report Date
    October 8, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 07/01/1998 IN THE POSTERIOR MANDIBLE. THE RESTORATIVE DR DISCOVERED MOBILITY. THE PT HAD NOT COMPLAINED OF PAIN. THE IMPLANT WAS REMOVED 09/02/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 5X11.5 SELF-TAPPING IMPLANT WITH MOUNT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-50-11 75982153

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention