BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX HYBRID ONE-LEVEL PLATE, SIZE 12MM

    MDR report key: 1640247 · Received February 5, 2010

    Report

    Report Number
    9617544-2009-00559
    Event Type
    Injury
    Date Received
    February 5, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (4) 2006 TO (B) (4) 2008 WERE WITHIN SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION (B) (4). THERE ARE 5 REPORTABLE EVENTS ASSOCIATED WITH THIS EVENT TYPE (SERIOUS INJURY) AND PRODUCT CODE KWQ.

    Description of Event or Problem · 1

    ADDITION OF SUPPLEMENTAL FIXATION. POSTERIOR ELEMENTS ADDED TO TREAT THE NONUNION/ADJACENT LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX HYBRID ONE-LEVEL PLATE, SIZE 12MM NA KWQ STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other