BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CURVED BROAD LCP PLATE 13 HOLES/247MM

    MDR report key: 2221539 · Received August 18, 2011

    Report

    Report Number
    8030965-2011-00557
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    August 1, 2011
    Report Date
    July 29, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K041911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A SEVERELY OVERWEIGHT PT WITH A PERIPROSTHETIC HIP, DISTAL FRACTURE, STATUS POST CURVED BROAD LCP PLATE IMPLANTATION IN (B)(6) 2011, EXPERIENCED A FALL ON AN UNKNOWN DATE. X-RAYS SHOWED, THE PLATE WAS BROKEN. ON (B)(6) 2011, THE HARDWARE WAS REMOVED AND THE SURGEON NOTED A NONUNION OF THE FRACTURE. PT WAS REVISED TO A NEW IMPLANT OF THE SAME TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM CURVED BROAD LCP PLATE 13 HOLES/247MM CURVED BROAD LCP PLATE KTT SYNTHES GMBH 2457375

    Patients

    Seq Age Sex Outcome Treatment
    1 Female CABLES.| POSITIONING PINS.| SCREWS.| SCREWS| POSITIONING PINS| CABLES