BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASYS 4.0 X 10MM PLATE SCREW

    MDR report key: 2915310 · Received January 9, 2013

    Report

    Report Number
    9617544-2013-90015
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE, THIS WILL BE REPORTED AS SUPPLEMENTAL.

    Description of Event or Problem · 1

    DURING OASYS SURGERY, THE SURGEON USED THE PLATE. THE SCREW WAS UNSTABLE WHEN THE SURGEON TRIED TO INSERT THE PLATE SCREW BY THE DRIVER. WHEN THE SURGEON INSERTED THE PLATE SCREW TO THE PARTWAY, SCREW HEAD WORE OUT. THEREFORE THE SURGEON CHANGED THE PLATE SCREW TO SAME SIZE SCREW. THE SURGERY WAS COMPLETED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13167 OASYS 4.0 X 10MM PLATE SCREW IMPLANT KWP STRYKER SPINE BORDEAUX NA E4J

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR