BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 4X13 SELF-TAP+

    MDR report key: 36078 · Received August 28, 1996

    Report

    Report Number
    2184002-1996-00159
    Event Type
    Injury
    Date Received
    August 28, 1996
    Date of Event
    July 31, 1996
    Report Date
    August 28, 1996
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED ON 1/18/96. SOME PAIN, NO SWELLING, NO INFLAMMATION, LOOSE. DID NOT INTEGRATE. 3 IMPLANTS WERE PUT IN, 2 ARE INTEGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 4X13 SELF-TAP+ Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-40-13 75950555

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention