BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 4.5/5 BROAD 10HO L188 TI

    MDR report key: 2971305 · Received February 21, 2013

    Report

    Report Number
    2520274-2013-01098
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: PAT WAS IMPLANTED WITH PLATE AND SCREWS FOR FEMUR SHAFT FRACTURE ON (B)(6) /2012. ON (B)(6) 2013 DURING REHABILITATION, THE SURGEON FOUND A RE FRACTURE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013, HARDWARE WAS REMOVED AND PATIENT WAS REVISED TO AN IM NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75892 LCP 4.5/5 BROAD 10HO L188 TI LCP 4.5/5 BROAD 10HOLE KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention