BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CURVED BROAD LCP PLATE

    MDR report key: 2120476 · Received April 27, 2011

    Report

    Report Number
    1719045-2011-00227
    Event Type
    Injury
    Date Received
    April 27, 2011
    Report Date
    April 13, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTT
    PMA / PMN Number
    K041911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH THE CURVED LOCKING COMPRESSION PLATE AT A DIFFERENT HOSPITAL BY A DIFFERENT SURGEON. ORIGINAL SURGERY - PERIPROSTHETIC HIP FRACTURE FIXATION. AT 3 MONTHS STATUS POST, PLATE BROKE AND NON-UNION WAS NOTED. PLATE WAS REMOVED ON (B)(6) 2011. SURGEON REVISED PATIENT TO FEMORAL STRUTS AND CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM CURVED BROAD LCP PLATE LCP PLATE KTT SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention