BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYSTON INTERBODY SPACER SYSTEMS

    MDR report key: 2509832 · Received March 29, 2012

    Report

    Report Number
    0002242816-2012-00027
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 2, 2012
    Manufacturer
    EBI, LLC
    Product Code
    BZD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE REPORTED EVENT. THE THREADED END OF THE SHAFT TIP SHEAR OFF. THE MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO DIMENSIONAL, FUNCTIONAL OR MATERIAL ANOMALIES FOUND IN THE DOCUMENTATION. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE REPORTED EVENT IS EXCESSIVE DEFLECTION FORCES. UNDER THOSE CONDITIONS, THE SHAFT THREAD WOULD BE THE REGION OF THE INSTRUMENT WITH THE SMALLEST CROSS-SECTIONAL AREA AND MORE PRONE TO BREAKAGE.

    Description of Event or Problem · 1

    TIP OF THE DRIVER FRACTURED DURING THE PROCEDURE. TIP REMAINS EMBEDDED IN THE IMPLANTED PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYSTON INTERBODY SPACER SYSTEMS CURVE VARIABLE INSERTER SHAFT BZD EBI, LLC N/A PT15D

    Patients

    Seq Age Sex Outcome Treatment
    1