BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP PROXIMAL FEMUR PLATE 6 HOLES/211MM-LEFT

    MDR report key: 2142367 · Received June 21, 2011

    Report

    Report Number
    3003506883-2011-00040
    Event Type
    Injury
    Date Received
    June 21, 2011
    Report Date
    June 3, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K030858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT STATUS POST COMMINUTED RESERVE INTER-TROCH PLATE AND SCREW PROCEDURE RETURNED TO SURGEON COMPLAINING OF PAIN. AN X-RAY SHOWED THE LCP FEMORAL PLATE BROKE AT THE THIRD HOLE. SURGEON REMOVED HARDWARE REVISION PT TO A LONG TFN WITH A LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP PROXIMAL FEMUR PLATE 6 HOLES/211MM-LEFT LCP PROXIMAL FEMUR PLATE HRS SYNTHES ELMIRA NA 5156756

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Required Intervention SCREW