BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP PROXIMAL FEMUR

    MDR report key: 1903469 · Received November 15, 2010

    Report

    Report Number
    3003506883-2010-00061
    Event Type
    Injury
    Date Received
    November 15, 2010
    Report Date
    October 22, 2010
    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

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SYNTHES, A PT STATUS POST PLATE AND SCREW IMPLANTATION HAD AN X-RAY TAKEN THAT SHOWED A BROKEN PLATE. THE DEVICE REPORT STATES THAT MEDICAL/SURGICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP PROXIMAL FEMUR PROXIMAL FEMUR PLATES HRS SYNTHES ELMIRA NA 6045102

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREW