BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIUM CUSTOM CRANIAL IMPLANT

    MDR report key: 1640257 · Received February 5, 2010

    Report

    Report Number
    8010177-2009-00247
    Event Type
    Injury
    Date Received
    February 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    KKY
    PMA / PMN Number
    K043250
    Removal / Correction Number
    Z-0510-2009
    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 SYSTEMS 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 2 EVENT ASSOCIATED WITH THIS EVENT TYPE (SERIOUS INJURY) AND PRODUCT CODE (KKY).

    Description of Event or Problem · 1

    SERIOUS INJURY. SALES REP FOUND OUT ABOUT POST OPERATIVE CASE REGARDING A PT WHO HAS HAD 2 FLUID INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIUM CUSTOM CRANIAL IMPLANT IMPLANT KKY STRYKER OSTEOSYNTHESIS FREIBURG NA 0660610165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other