BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA SPINAL FIXATION SYSTEM

    MDR report key: 2941008 · Received October 17, 2006

    Report

    Report Number
    2941008
    Event Type
    Malfunction
    Date Received
    October 17, 2006
    Date of Event
    October 2, 2006
    Report Date
    October 16, 2006
    Manufacturer
    ZIMMER SPINE INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO THE ED WITH COMPLAINT OF SEVERE BACK AND LEG PAIN. SHE IS S/P L4-5 DECOMPRESSION IN (B)(6) 2006. X-RAYS SHOW 2 OF THE SCREWS HAVE FRACTURED, AT 5, WITH MINIMAL DISPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA SPINAL FIXATION SYSTEM NONE KWQ ZIMMER SPINE INC. SPA 6045
    2 OPTIMA SPINAL FIXATION SYSTEM NONE KWQ ZIMMER SPINE INC SPA 6040

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR