BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST360 SPINAL FIXATION SYSTEM

    MDR report key: 940056 · Received April 10, 2007

    Report

    Report Number
    2184052-2007-00007
    Event Type
    Malfunction
    Date Received
    April 10, 2007
    Date of Event
    March 12, 2007
    Report Date
    March 14, 2007
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REPORTED THAT SUCCESSFUL FUSION OCCURRED AT THE LEVELS L4 TO S1. IT IS UNKNOWN WHEN THE ROD MIGRATION OCCURRED AND WAS IDENTIFIED APPROXIMATELY 11 MONTH POST-OP. THE ST360 INSTRUCTIONS FOR USE (07.00514.001 REV. G) STATES IN THE COMPLICATIONS AND POSSIBLE ADVERSE EFFECTS SECTION, "LOOSENING, DISASSEMBLY, BENDING OR BREAKAGE OF COMPONENTS."

    Description of Event or Problem · 1

    ORIGINAL SURGERY DATE WAS 2006, L4/S1. SURGEON REPORTED A 6.35MM ROD, ON PATIENTS LEFT SIDE, MIGRATED OUT OF THE L4 CONNECTOR AND HAS MIGRATED DOWN TOWARDS THE L5 AND S1 CONNECTORS. THE 6.35MM ROD ON THE PATIENTS RIGHT SIDE MAY BE SLIPPING AS WELL. IT IS UNKNOWN WHEN THE ROD MIGRATED OUT OF THE CONNECTOR. X-RAYS WERE OBTAINED FROM THE CASE. X-RAYS TAKEN ELEVEN DAYS LATER, SHOW THE RODS IN CORRECT POSITION. X-RAYS TAKEN ONE MONTH PRIOR, REVEAL THE LEFT ROD IN PATIENT IS NOT IN THE CORRECT POSITION. IT APPEARS THE ROD ON PATIENT RIGHT SIDE HAS MIGRATED SLIGHTLY. THE DEVICES RESIDE IN THE PATIENT. THE SURGEON STATED THAT THE PATIENT IS SUCCESSFULLY FUSED AT THESE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST360 SPINAL FIXATION SYSTEM ST360 CONNECTOR KWQ ZIMMER SPINE, INC. 07.00295.004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR