BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.4X10 TPS CYLIND

    MDR report key: 161262 · Received April 7, 1998

    Report

    Report Number
    2184002-1998-00242
    Event Type
    Injury
    Date Received
    April 7, 1998
    Date of Event
    October 1, 1997
    Report Date
    April 7, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 5/11/1997. ON 10/97, PT CAME TO CLINIC WITH THE IMPLANT IN HIS HAND. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.4X10 TPS CYLIND Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9040-34-10 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention