BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UHR BIPOLAR 28X45MM

    MDR report key: 1679101 · Received May 2, 2010

    Report

    Report Number
    2249697-2009-00992
    Event Type
    Malfunction
    Date Received
    May 2, 2010
    Date of Event
    October 20, 2006
    Report Date
    October 20, 2006
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    KWL
    PMA / PMN Number
    K800207
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 ARE 4 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DIMENSIONAL DISCREPANCY) AND PRODUCT CODE KWL. DHR AND COMPLAINT HISTORY REVIEW.

    Description of Event or Problem · 1

    (B) (4): DIMENSIONAL DISCREPANCY. IT WAS REPORTED UHR HEAD DID NOT FIT. OPENED ANOTHER HEAD WHICH DID FIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UHR BIPOLAR 28X45MM IMPLANT KWL STRYKER ORTHOPAEDICS NA 0R9MJA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA