BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP PROXIMAL FEMUR PLATE 10 HOLES/283MM-LEF

    MDR report key: 2211380 · Received August 9, 2011

    Report

    Report Number
    8030965-2011-00537
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    July 14, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K030858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PT IMPLANTED WITH AN LCP PROXIMAL FEMUR PLATE ON AN UNK DATE. THE PLATE BROKE POSTOPERATIVELY AND WAS REMOVED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP PROXIMAL FEMUR PLATE 10 HOLES/283MM-LEF LCP PROXIMAL FEMUR PLATE HRS SYNTHES ELMIRA 6006281

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention