BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VLIFT EXPANDER

    MDR report key: 3955338 · Received July 24, 2014

    Report

    Report Number
    0009617544-2014-00323
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE DEVICE FRACTURED AS A RESULT OF REVERSED BENDING FATIGUE AND ROTATING BENDING FATIGUE. THIS INDICATES THAT THE DEVICE WAS EXPERIENCING A CANTILEVER LOAD AT THE TIME OF FRACTURE. CONCLUSION: THE PLAUSIBLE ROOT CAUSE OF THE REPORTED EVENT IS A USER APPLIED CANTILEVER LOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING VLIFT CAGE SURGERY, THE SURGEON INSERTED THE CAGE USING EXPANDER. THE SURGEON CHECKED THE STABILITY OF THE CAGE. WHEN THE EXPANDER WAS MOVED, THE BASE OF THE INNER SHAFT BROKE. THE SURGEON REMOVED EXPANDER AND FINISHED THE OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING VLIFT CAGE SURGERY, THE SURGEON INSERTED THE CAGE USING EXPANDER. THE SURGEON CHECKED THE STABILITY OF THE CAGE. WHEN THE EXPANDER WAS MOVED, THE BASE OF THE INNER SHAFT BROKE. THE SURGEON REMOVED EXPANDER AND FINISHED THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433578 VLIFT EXPANDER INSTRUMENT-EXPANDER LXH STRYKER SPINE-FRANCE 135544

    Patients

    Seq Age Sex Outcome Treatment
    1