BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIELKE PEDICLE SCRW

    MDR report key: 19915 · Received February 22, 1995

    Report

    Report Number
    MW1005198
    Event Type
    Injury
    Date Received
    February 22, 1995
    Date of Event
    May 14, 1987
    Report Date
    February 5, 1995
    Manufacturer
    STUART DRUG AND SURGICAL SUPPLY, INC.
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    OPERATION: BILATERAL LATERAL FUSION, WITH DEVICE, L5 TO SACRUM USING AUTOGENOUS BONE GRAFT. ONE OF THE PEDICLE SCREWS IS NOW FRACTURED AND CAN BE SEEN ON X-RAY, BELIEVE IT BROKE IN 8/87. PERSISTENT SEVERE BACK PAIN SINCE BACK SURGERY AND RPTR WALKS WITH CANE. HARDWARE STILL IN BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIELKE PEDICLE SCRW Implant SCREW AND ROD MCV STUART DRUG AND SURGICAL SUPPLY, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| S