BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS 3.5 X 10MM POLYAXIAL SCREW

    MDR report key: 2930338 · Received January 22, 2013

    Report

    Report Number
    9617544-2013-90043
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 28, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    K032394
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "SCREWS PULLED OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29511 OASYS 3.5 X 10MM POLYAXIAL SCREW IMPLANT KWP STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R POLYAXIAL SCREW| OASYS 3.5 X 20/12MM 48552320/12