BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LCP DISTAL FEMUR PLATE

    MDR report key: 2041294 · Received March 29, 2011

    Report

    Report Number
    8030965-2011-00119
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 9, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K062564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ONGOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PATIENT WITH TI LCP DISTAL FEMUR PLATE. PLATE BROKE AND PATIENT UNDERWENT REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LCP DISTAL FEMUR PLATE DISTAL FEMUR PLATE HRS SYNTHES GMBH NA 2563722

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS