BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 180802 · Received July 29, 1998

    Report

    Report Number
    180802
    Event Type
    Other
    Date Received
    July 29, 1998
    Report Date
    June 19, 1998
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Product Code
    JEY
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REQUEST FOR INFORMATION FROM WALTER LORENZ SURGICAL INC FOR INFORMATION CONCERNING 2.0 MM BONE PLATE. THIS DEVICE WAS INSTALLED WITH SEVERAL OTHER BONE PLATES. IN THIS PT AT THE SAME TIME, CO DOES NOT KNOW WHAT KIND OF INCIDENT OCCURRED. NO RESPONSE FROM DR ORDER SEVERAL ATTEMPTS TO CLARIFY INCIDENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant 2.0 MM BONE PLATE JEY WALTER LORENZ SURGICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other