BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.75X13 SELF-TAP +

    MDR report key: 166660 · Received May 11, 1998

    Report

    Report Number
    2184002-1998-00346
    Event Type
    Injury
    Date Received
    May 11, 1998
    Date of Event
    June 16, 1995
    Report Date
    May 11, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS PLACED 3/22/1995. IT WAS REMOVED 6/16/1995 DUE TO NON-INTEGRATION, POSSIBLY DUE TO OVERHEATING OF THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.75X13 SELF-TAP + Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. ISS962 75940138

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention