BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO TS TIB INSERT

    MDR report key: 1621884 · Received February 5, 2010

    Report

    Report Number
    2249697-2009-00972
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    July 3, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    MBH
    PMA / PMN Number
    K994128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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) (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 (DIMENSIONAL DISCREPANCY) AND PRODUCT CODE MBH.

    Description of Event or Problem · 1

    DIMENSIONAL DISCREPANCY. THE TRIAL DID NOT HAVE ANY PROBLEM; HOWEVER, THE IMPLANT COULD NOT FIT RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO TS TIB INSERT IMPLANT MBH STRYKER ORTHOPAEDICS NA 11919202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other