BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PRIM CEM FXD BPLT #5

    MDR report key: 1881589 · Received October 20, 2010

    Report

    Report Number
    9610726-2010-00374
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    MBH
    PMA / PMN Number
    K072575
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SURGEON STATES THAT THE PRINTING AND VERTICAL LINES ARE NOT PRINTED IN THE MIDDLE OF THE BASEPLATE (KEEL SHOULD BE IN THE MIDDLE OF THOSE VERTICAL LINES). HE MANAGED TO CONTINUE THE OPERATION TAKING ANOTHER BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PRIM CEM FXD BPLT #5 IMPLANT MBH STRYKER ORTHOPAEDICS LIMERICK NA SXCCT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R