BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE SYSTEM 5 ROD, TITANIUM ALLOY, 150MM

    MDR report key: 223876 · Received May 13, 1999

    Report

    Report Number
    2916714-1999-00009
    Event Type
    Malfunction
    Date Received
    May 13, 1999
    Date of Event
    November 13, 1997
    Report Date
    May 13, 1999
    Manufacturer
    AESCULAP - JBS S.A.
    Product Code
    MNH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INITIAL BACK SURGERY ON 11/19/1996; SPONDYLOLISTHESIS AT L4-L5 WITH FACET HYPERTROPHY AND DEGENERATIVE CHANGE THROUGH FACET JOINT, SPONDYLOSIS, UNSTABLE LOW BACK. OPERATION PERFORMED WAS LAMINECTOMY AT L3-S1 WITH FUSION AT L2-S1 AND INTERNAL FIXATION AT L2-S1. DUE TO PAIN IN BACK AND LEGS AND (2) FRACTURED RODS, A REOPERATION WAS PERFORMED ON 11/13/1997. INITIAL HARDWARE WAS REMOVED AND REPLACED WITH 2 METALLIC FIXATION SCREWS AND INTERBODY FUSION WAS PERFORMED AT L4-L5 WITH BAK IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE SYSTEM 5 ROD, TITANIUM ALLOY, 150MM Implant SPINAL IMPLANT FIXATION DEVICE MNH AESCULAP - JBS S.A. NA LT04JC7/1GJ

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R