BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA-LCP CONDYLAR PLATE 4.5/5.0 LE 16HO L3

    MDR report key: 2960257 · Received February 14, 2013

    Report

    Report Number
    8030965-2013-00448
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 16, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDP
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH VA-LCP CONDYLAR PLATE CONSTRUCT ON (B)(6) 2012. ON (B)(6) 2012, PAIN IN THE THIGH WAS NOTED. REPORTEDLY THE PLATE BROKE POST-OPERATIVELY. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. PATIENT WAS TREATED BY RE-LAMINOFIXATION AND CEMENT SPACER AND BONE GRAFT. PATIENT WAS PRESCRIBED PARTIAL WEIGHT BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64368 VA-LCP CONDYLAR PLATE 4.5/5.0 LE 16HO L3 PLATE JDP SYNTHES GMBH 8038937

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention