BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUQUE PEDICLE WRAP

    MDR report key: 18198 · Received December 2, 1994

    Report

    Report Number
    MW1004296
    Event Type
    Other
    Date Received
    December 2, 1994
    Date of Event
    March 25, 1991
    Report Date
    November 18, 1994
    Manufacturer
    ZIMMER, INC.
    Product Code
    MCV
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MAJOR BACK SURGERY DECOMPESSION L-1, L-2, L-3, L-4, AND L-5. SURGEON USED A PEDICLE WRAP WHICH TRANSVERSE FUSION. NOW RPTR HAS PAIN, SEVERE NUMBNESS OF LOWER EXTREMITIES AND OUTER LEFT THIGH AND SEVERE ACHE OF LOWER RIGHT OUTER THIGH AND LOWER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUQUE PEDICLE WRAP Implant STEEL BRACE AND 7 SCREWS MCV ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other