BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 5.5 X 40

    MDR report key: 6089748 · Received November 9, 2016

    Report

    Report Number
    0009617544-2016-00447
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 14, 2016
    Report Date
    May 24, 2017
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    UDI-DI
    04546540450180
    PMA / PMN Number
    K121342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: RISK ASSESSMENT; RESULTS: VISUAL, ANALYSIS, DEVICE HISTORY AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. NO LOT # WAS PROVIDED, SO A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE PLAUSIBLE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; ROD SLIPPED OUT OF SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; ROD SLIPPED OUT OF SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742430 XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 5.5 X 40 PEDICLE SCREW SPINAL SYSTEM NKB STRYKER SPINE-FRANCE UNKNOWN 04546540450180

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO