BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 4.5/5 BROAD CURV 12HO L229 TI

    MDR report key: 2256885 · Received September 16, 2011

    Report

    Report Number
    8030965-2011-00615
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    June 27, 2011
    Report Date
    August 19, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE REPORTED AS AUGUST 2020. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM (B)(6) REPORTS A PT WITH A RIGHT FEMORAL FRACTURE WAS PLATED ON (B)(6) 2011. BAND WIRE WAS USED FOR MORE RIGID FIXATION. HWB STARTED (B)(6) 2011 AND FWB STARTED IN (B)(6) 2011. THREE MONTHS AFTER FWB THE PLATE WAS BROKEN; DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP 4.5/5 BROAD CURV 12HO L229 TI LCP 4.5/5 BROAD CURV 12HO L229 TI KTT SYNTHES GMBH 3526526

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SCREWS| WIRE