BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SECUR FIT PLUS

    MDR report key: 1620561 · Received February 5, 2010

    Report

    Report Number
    9616680-2009-00667
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    April 6, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK, STRYKER ORTHOPAEDICS
    Product Code
    MEH
    PMA / PMN Number
    K020615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 DECISION. 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 ARE 4 EVENTS ASSOCIATED WITH THIS EVENT TYPE (POST OPERATIVE ADVERSE RESULT AND PRODUCT CODE MEH).

    Description of Event or Problem · 1

    POST OPERATIVE ADVERSE RESULT. IT WAS REPORTED THAT, "DOCTOR REPORTED THAT PT HAS PAIN ON LATERAL SIDE OF THIGH (RECENT ONSET). UPON HAVING XRAY TAKEN A SMALL, SHARP, FRAGMENT IS NOTED. THERE HAVE BEEN NO FALLS AND LOTS OF ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER SECUR FIT PLUS IMPLANT MEH STRYKER ORTHOPAEDICS CORK, STRYKER ORTHOPAEDICS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other