BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE

    MDR report key: 2071024 · Received April 20, 2011

    Report

    Report Number
    9610726-2011-00120
    Event Type
    Other
    Date Received
    April 20, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    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. ADD'L INFO PERTAINING TO THE EVENT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR# 9610726-2011-00121.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "REP WAS TOLD BY THE DOCTOR AND FIRST ASSIST THAT WHILE THEY WERE CEMENTING THE COMPONENTS THEY USED THE BOVIE AND THEY SAID THAT THE CEMENT CAUGHT ON FIRE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA MAS005

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other