BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WUBU MINI SCREWS, C-F, S-T, 1.7X3

    MDR report key: 1640255 · Received February 5, 2010

    Report

    Report Number
    8010177-2009-00246
    Event Type
    Injury
    Date Received
    February 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    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 MID 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 IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (SERIOUS INJURY) AND PRODUCT CODE (JEY).

    Description of Event or Problem · 1

    SERIOUS INJURY. SURGEON REPORTED PART NUMBERS FOR THE PLATES AND SCREWS IMPLANTED ON HER PT'S MID FACE. THE PT IS EXPERIENCING RASHES AND ACNE WHICH THEY BELIEVE IS A RESULT OF THE METALLIC COMPOSITION OF THE PLATES AND SCREWS. THE PLATES AND SCREWS WERE IMPLANTED IN (B) (6) OF 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WUBU MINI SCREWS, C-F, S-T, 1.7X3 IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other