BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOW FEM/DIST CENTRALIZER 10MM

    MDR report key: 1679097 · Received May 2, 2010

    Report

    Report Number
    9610726-2009-00291
    Event Type
    Malfunction
    Date Received
    May 2, 2010
    Date of Event
    January 24, 2008
    Report Date
    January 28, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    JDG
    PMA / PMN Number
    K851566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORP CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (USER RELATED) AND PRODUCT CODE JDG. DHR COMPLAINT HISTORY REVIEW.

    Description of Event or Problem · 1

    STRYKER PER: (B) (4) - USER RELATED. IT WAS REPORTED THAT, "IMPLANTED EXPIRED PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOW FEM/DIST CENTRALIZER 10MM IMPLANT JDG STRYKER ORTHOPAEDICS NA TCGC5011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA