BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2090864 · Received May 11, 2011

    Report

    Report Number
    8030965-2011-00219
    Event Type
    Injury
    Date Received
    May 11, 2011
    Report Date
    May 4, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K030858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE CONCLUDED AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH A 4.5 MM LCP PROXIMAL FEMUR PLATE. TWO WEEKS POSTOP, THE PLATE WAS NOTED AS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP PROXIMAL FEMUR PLATE 8 HOLES/247 MM-LEFT LCP PROXIMAL FEMUR PLATE HRS SYNTHES ELMIRA NA 6404315

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention