BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB-DF PLATE, RIGHT, 5 HOLES

    MDR report key: 1030857 · Received April 9, 2008

    Report

    Report Number
    9613350-2008-00017
    Event Type
    Injury
    Date Received
    April 9, 2008
    Date of Event
    December 6, 2007
    Report Date
    April 9, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS IMPLANTED FOR SUPRACONDYLAR FEMUR FRACTURE DATED FOR 2008. THE PLATE WAS BROKEN ABOUT FOUR MOS AFTER SURGERY. THE OPERATOR COULD NOT CONTROL THE WEIGHT BEARING BECAUSE THE PT MOVED TO ANOTHER HOSPITAL AFTER 6 WEEKS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCB-DF PLATE, RIGHT, 5 HOLES NCB PLATING SYSTEM HRS ZIMMER GMBH NA 2292505

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R