BEUDAMED
    FDA Adverse Event Other Summary report: N

    REUNION HA FRACTURE STEM 7MM

    MDR report key: 2013063 · Received March 1, 2011

    Report

    Report Number
    2249697-2011-00231
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSD
    PMA / PMN Number
    K070963
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE NURSE OPENED THE IMPLANT AND THE IMPLANT FELL OUT ONTO THE FLOOR. NO BAD OUTCOME CAME. WE USED A DIFFERENT IMPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUNION HA FRACTURE STEM 7MM IMPLANT HSD STRYKER ORTHOPAEDICS MAHWAH NA T2S72420-E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other