BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 4X15 TPS SCREW IMPLANT

    MDR report key: 186578 · Received September 11, 1998

    Report

    Report Number
    2184002-1998-00616
    Event Type
    Injury
    Date Received
    September 11, 1998
    Date of Event
    August 1, 1998
    Report Date
    August 14, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    2 IMPLANTS WERE PLACED 06/04/1998 IN THE LOWER CUSPID. THEY FAILED AND WERE REMOVED "JULY/AUGUST". ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 4X15 TPS SCREW IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9020-40-15 75981566

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention