BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE SYSTEM

    MDR report key: 38126 · Received August 12, 1996

    Report

    Report Number
    2916714-1996-00003
    Event Type
    Injury
    Date Received
    August 12, 1996
    Date of Event
    July 10, 1996
    Report Date
    August 12, 1996
    Manufacturer
    JBS, SA
    Product Code
    JBS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGICAL REVISION WAS COMPLETED ON 08/15/96. THE FRACTURED SCREW ON THE LEFT SIDE OF L4 AND AN UNFRACTURED SCREW ON THE RIGHT WERE EXPLANTED. BOTH SCREWS WERE REPLACED WITH 7MM SCREWS, ALONG WITH ADDITIONAL RODS AND NUTS. THE LINKING PLATES WERE PLACED FROM SIDE TO SIDE AT L5 AND L4 TO ADD ADDITIONAL STRENGTH. THE PATIENT WAS IN SATISFACTORY CONDITION POST-OP AND AT POST-OP OFFICE VISIT ON 08/28/96, PATIENT REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE SYSTEM Implant BONE SCREW JBS JBS, SA NA LT101 JG1

    Patients

    Seq Age Sex Outcome Treatment
    1 52 * Other| R