BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.75X13 TPS SCREW IMPLANT

    MDR report key: 197824 · Received November 19, 1998

    Report

    Report Number
    2184002-1998-00817
    Event Type
    Injury
    Date Received
    November 19, 1998
    Date of Event
    May 7, 1998
    Report Date
    November 19, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 04/23/1997 IN SITE #4. IMPLANT FAILED AND WAS REMOVED 05/07/1998. IT WAS REMOVED DUE TO GRANULOMA. THERE WAS A VERTICAL BONE DEFECT PROXIMAL TO THE IMPLANT X-RAY INDICATED BONE LOSS. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.75X13 TPS SCREW IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9020-38-13 75970910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention