BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.3X8 SELF-TAP +

    MDR report key: 165953 · Received May 6, 1998

    Report

    Report Number
    2184002-1998-00333
    Event Type
    Injury
    Date Received
    May 6, 1998
    Date of Event
    February 23, 1998
    Report Date
    May 6, 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

    PATIENT: PLACED 10/21/1997, REMOVED 2/23/1998. IMPLANT FAILED DUE TO POOR BONE QUALITY. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.3X8 SELF-TAP + Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-33-08 75980266

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention