BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE CALCAR PLANER

    MDR report key: 1884406 · Received October 21, 2010

    Report

    Report Number
    2249697-2010-01388
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED TO ME BY ONE OF THE NURSING STAFF PRESENT AT THE TIME. SHE TOLD ME THAT FRACTURED THE PATIENT'S FEMUR WHILST USING THE CALCAR PLANAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE CALCAR PLANER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA F3A3397

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R