BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITRAX MODULAR ENDO HEAD 50MM

    MDR report key: 1629282 · Received February 5, 2010

    Report

    Report Number
    2249697-2009-00989
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    January 4, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    KWL
    PMA / PMN Number
    K902365
    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 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 THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION (B) (4). THERE ARE 2 EVENTS ASSOCIATED WITH THIS EVENT TYPE (USER RELATED) AND PRODUCT CODE KLW.

    Description of Event or Problem · 1

    USER RELATED. IT WAS REPORTED THAT "SALES REP NOTICED THAT THE IMPLANT HAD EXPIRED ON 12/2006 AFTER DOCTOR BENIVADES HAD IMPLANTED IT AND REDUCE THE FRACTURE. SALES REP EXPLAINED TO DR (B) (6) THAT THE IMPLANT WAS EXPIRED. DR (B) (6) ASKED WHAT THE EXPIRATION DATE WAS. SALES REP STATED THAT IT WAS 12/2006. DR (B) (6) STATED THAT HE WAS NOT GOING TO WORRY ABOUT IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNITRAX MODULAR ENDO HEAD 50MM IMPLANT KWL STRYKER ORTHOPAEDICS NA KOCV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other