BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEFFEE

    MDR report key: 298015 · Received September 26, 2000

    Report

    Report Number
    1526439-2000-00019
    Event Type
    Other
    Date Received
    September 26, 2000
    Date of Event
    August 22, 2000
    Report Date
    September 25, 2000
    Manufacturer
    DEPUY ACROMED
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEPUY ACROMED REC'D A MEDWATCH FORM FROM THE COMPLAINANT. ACCORDING TO THE COMPLAINANT, SIX YEARS AFTER THE PT HAD BEEN IMPLANTED WITH STEFFEE INSTRUMENTATION, A PEDICLE SCREW WAS FOUND TO BE BROKEN AT L4. THE PT HAD A RE-OPERATION FOR EXPLORATION AND REMOVAL OF THE HARDWARE FROM L4-L5. A PORTION OF THE BROKEN SCREW WAS LEFT IN L4. IN THE PACKAGE INSERT THAT ACCOMPANIES THE INSTRUMENTATION, PRECAUTIONS ARE LISTED. ONE PRECAUTION SPECIFICALLY STATES THAT "BENDING, LOOSENING, AND/OR BREAKAGE" MAY OCCUR IF THE DEVICE IS NOT REMOVED FOLLOWING THE "COMPLETION OF ITS INTENDED USE". ACCORDING TO THE COMPLAINANT, THE STEFFEE INSTRUMENTATION WAS IMPLANTED IN 1994, SIX YEARS AGO. IF SUCCESSFUL FUSION TOOK PLACE, THE IMPLANTS WERE WELL PAST THE COMPLETION OF THEIR INTENDED USE. THE PARTS WERE NOT RETURNED FOR EVAL. NO FURTHER ACTION CAN BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEFFEE SCREWS AND PLATES MCV DEPUY ACROMED NA M1824, M1879

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other