BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE)

    MDR report key: 3241512 · Received July 22, 2013

    Report

    Report Number
    0008010177-2013-00165
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION AS IT IS STILL IMPLANTED IN PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PER THE SALES REPRESENTATIVE, THE RESIDENT WAS TWISTING THE SCREW INTO THE PATIENT'S SKULL AND THE SCREW HEAD BROKE OFF FROM THE REST OF THE SCREW. THE BODY OF THE SCREW WAS UNABLE TO BE REMOVED AND IS LEFT IN THE PATIENT'S SKULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340376 LOCKING SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE) SCREW JEY STRYKER OSTEOSYNTHESIS-FREIBURG 0

    Patients

    Seq Age Sex Outcome Treatment
    1