BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP PROXIMAL FEMUR PLATE 8 HOLES/247MM-LEFT

    MDR report key: 2221608 · Received August 19, 2011

    Report

    Report Number
    3003506883-2011-00515
    Event Type
    Injury
    Date Received
    August 19, 2011
    Report Date
    August 4, 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. DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    FACILITY IN (B)(6) REPORTED THAT AN LCP PLATE BROKE POST OPERATIVELY AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP PROXIMAL FEMUR PLATE 8 HOLES/247MM-LEFT PROXIMAL FEMUR PLATE HRS SYNTHES ELMIRA 6470539

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS