BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 4X10 TPS SCREW

    MDR report key: 166655 · Received May 11, 1998

    Report

    Report Number
    2184002-1998-00347
    Event Type
    Injury
    Date Received
    May 11, 1998
    Date of Event
    April 10, 1998
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS PLACED 3/24/1998, TEETH 20. IT WAS REMOVED 4/10/1998 DUE TO SWELLING, PAIN, ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 4X10 TPS SCREW Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9020-40-10 75970398

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention