BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRO OSCILLATING SAW

    MDR report key: 1066213 · Received June 27, 2008

    Report

    Report Number
    1811755-2008-00028
    Event Type
    Death
    Date Received
    June 27, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 27, 2008
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K032303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED; HOWEVER IT IS SCHEDULED TO BE EVALUATED ON 07/11/2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CUTTING THE STERNUM DURING A STERNOTOMY REDO PROCEDURE THE SAW CUT INTO THE PT'S AORTA. THE PT WAS PLACED ON FEMORAL BYPASS WHILE AN ATTEMPT WAS MADE AT REPAIRING THE AORTA. IT WAS FURTHER REPORTED THAT THE PT DIED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO OSCILLATING SAW CORE SYSTEM HWE STRYKER INSTRUMENTS KALAMAZOO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death