BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROX. LAT. HUMERUS PLATE 5-HOLE / RIGHT

    MDR report key: 1620528 · Received February 5, 2010

    Report

    Report Number
    8031020-2009-00152
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    June 29, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH, STRYKER OSTEOSYNTHESIS
    Product Code
    KTT
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ARE 4 EVENTS ASSOCIATED WITH THIS EVENT TYPE (REVISION SURGERY REQUIRED) AND PRODUCT CODE (KTT).

    Description of Event or Problem · 1

    REVISION SURGERY REQUIRED. THE LOCKING SCREWS BACKED OUT POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROX. LAT. HUMERUS PLATE 5-HOLE / RIGHT IMPLANT KTT STRYKER OSTEOSYNTHESIS SELZACH, STRYKER OSTEOSYNTHESIS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention