BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE SYSTEM 5

    MDR report key: 41354 · Received October 2, 1996

    Report

    Report Number
    2916714-1996-00005
    Event Type
    Injury
    Date Received
    October 2, 1996
    Date of Event
    September 19, 1996
    Report Date
    October 2, 1996
    Manufacturer
    JBS SA
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOCALIZED INFECTION DEVELOPED IN PT POST-OPERATIVELY AFTER IMPLANTATION OF SPINE SYSTEM IMPLANTS. RE-OPERATION PERFORMED 9/19/96. PHYSICIAN ALSO FOUND NUTS WERE NOT TIGHTLY PLACED ON SCREW/ROD. NO ADD'L INFO ON PT STATUS OR EVENT AVAILABLE AT THIS TIME. ADD'L DATA HAS BEEN REQUESTED FROM THE PHYSICIAN. ACCORDING TO HOSP/STAFF, INFECTION ISSUE IS NOT ISOLATED TO THIS EVENT OR SPINE SYSTEM IMPLANTS. THIS EVENT IS OCCURRING BELOW THE FREQUENCY AND SEVERITY THAT ARE USUAL FOR THESE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE SYSTEM 5 Implant SPINAL IMPLANTS: SCREW, ROD, NUT JDN JBS SA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention