BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE SYSTEM 5 IMPLANTS

    MDR report key: 42433 · Received October 11, 1996

    Report

    Report Number
    2916714-1996-00006
    Event Type
    Injury
    Date Received
    October 11, 1996
    Date of Event
    October 2, 1996
    Report Date
    October 11, 1996
    Manufacturer
    JBS, SA
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REOPERATION PERFORMED ON 10/2/96 ON ELDERLY FEMALE PT DUE TO SPINAL IMPLANTS BECOMING LOOSE, POSSIBLY DUE TO TECHNIQUE USED DURING IMPLANTATION. IMPLANTS ORIGINALLY IMPLANTED ON 7/3/96: L3-5 ON LEFT SIDE, L4-5 ON RIGHT SIDE. ALL SPINE SYSTEM IMPLANTS REMOVED. SURGEON IMPLANTED ANOTHER GRAFT AND DIFFERENT HARDWARE. NO IMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE SYSTEM 5 IMPLANTS Implant PEDICLE SCREWS, RODS, NUTS MCV JBS, SA NA MANY SEE MFG RPT

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention