BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 5 RECIP/STERNUM SAW

    MDR report key: 2894000 · Received December 21, 2012

    Report

    Report Number
    1811755-2012-04340
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 25, 2012
    Report Date
    December 10, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVAL AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE AND THE DEVICE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, PARTICLES WERE FALLING OUT OF THE SAW. A BACK-UP DEVICE WAS USED TO COMPLETE THE CASE. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE, THE PT DEVELOPED AN INFECTION. THE BOARD OF INFECTION AND PHYSICIAN BOARD MET TO DISCUSS THE CASE. IT CANNOT BE DETERMINED IF THE INFECTION WAS CAUSED AS A RESULT OF THE PT BEING EXPOSED TO ANY PARTICLES COMING FROM THE DEVICE. IT WAS REPORTED THAT IT IS LIKELY THE INFECTION OCCURRED POST-OP DURING REHAB. THE PT WAS PRESCRIBED ANTIBIOTICS AND HAS NOT EXPERIENCED ANY FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 5 RECIP/STERNUM SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK