BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR ASSY TWO LEVEL PLATE SIZE 28

    MDR report key: 5999833 · Received October 5, 2016

    Report

    Report Number
    0009617544-2016-00401
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWQ
    UDI-DI
    07613252152187
    PMA / PMN Number
    K142237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: MANUFACTURING FILES WERE REVIEWED AND NO ANOMALIES WERE FOUND. CONCLUSION: THE PROBABLE ROOT CAUSE OF THE MECHANISM POPPING UP IS NOT DETERMINED AND MULTIFACTORAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; TWO 28MM ANTERIOR CERVICAL PLATES HAD THE LOCKING MECHANISM BRAKE DURING SCREW INSERTION. THE THIRD 28MM PLATE WAS INSERTED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; TWO 28MM ANTERIOR CERVICAL PLATES HAD THE LOCKING MECHANISM BRAKE DURING SCREW INSERTION. THE THIRD 28MM PLATE WAS INSERTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651478 AVIATOR ASSY TWO LEVEL PLATE SIZE 28 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ STRYKER SPINE-FRANCE 168418 07613252152187

    Patients

    Seq Age Sex Outcome Treatment
    1