BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA DEFORMITY UNI-PLANAR SCREW 5.5 X 45MM

    MDR report key: 2230711 · Received August 17, 2011

    Report

    Report Number
    9617544-2011-00288
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K080928
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION. TWO ADDITIONAL SCREWS WERE ALSO FILED WITH THE INITIAL REPORT. IF DURING THE INVESTIGATION IT'S DETERMINED THAT THEY WERE A CONTRIBUTOR TO THE EVENT, THEN AN ADDITIONAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SCREWS WERE IMPLANTED AND THE SURGEON NOTICED THAT THE TULIP OF THE SCREW WAS PISTONING. THE SALES REP NOTICED THAT THE RING OF THE SCREW POPPED OFF BUT WAS STILL ATTACHED TO THE SCREW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA DEFORMITY UNI-PLANAR SCREW 5.5 X 45MM IMPLANT NKB STRYKER SPINE BORDEAUX NA 092283

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention XIA DEFORMITY UNI-PLANAR SCREW 6.5 X 45 MM (2):| CAT 48223645, LOT 095303