BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.75X10 SELF-TAPPING IMPLANT WITH MOUNT

    MDR report key: 199332 · Received November 30, 1998

    Report

    Report Number
    2184002-1998-00839
    Event Type
    Injury
    Date Received
    November 30, 1998
    Date of Event
    November 3, 1998
    Report Date
    November 30, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 04/21/1998 IN SITE #3, SOFT BONE. IMPLANT WAS REMOVED 11/03/1998 DUE TO MOBILITY. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.75X10 SELF-TAPPING IMPLANT WITH MOUNT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-38-10 75971287

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention