BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-PREP BONE PREPARATION KIT

    MDR report key: 3026060 · Received March 28, 2013

    Report

    Report Number
    0001811755-2013-00648
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JDK
    PMA / PMN Number
    K931847
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED WHEN THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATIOIN HAS BEEN COMPLETED. NOT RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    UPON EVALUATION WEAR WAS OBSERVED ON THE SCULP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCULPT LEFT BLUE FLAKES IN THE PATIENT DURING A PROCEDURE. THE SURGEON WAS ABLE TO SUCTION THE ALL OF THE FLAKES FROM THE SURGICAL SITE WITHOUT PATIENT OR USER INJURIES, AND THERE WERE NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCUPLT LEFT BLUE FLAKES IN THE PATIENT DURING A PROCEDURE. THE SURGEON WAS ABLE TO SUCTION THE ALL OF THE FLAKES FROM THE SURGICAL SITE WITHOUT PATIENT OR USER INJURIES, AND THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128891 BIO-PREP BONE PREPARATION KIT PROSTHESIS, HIP, CEMENT RESTRICTOR JDK STRYKER INSTRUMENTS-KALAMAZOO 12264012

    Patients

    Seq Age Sex Outcome Treatment
    1