BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW, CROSS-PIN, SELF-TAPPING, DIAM.1.2X6MM, UPPERFACE, STERILE, (1/PACKAG

    MDR report key: 3141020 · Received June 3, 2013

    Report

    Report Number
    0008010177-2013-00105
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    JEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AS IT IS STILL IMPLANTED IN PATIENT. THE INCIDENT WAS NOTICED AFTER IMPLANTATION OF PLATES AND SCREWS, AND SO FAR, NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED. BASED ON THE EVENT DESCRIPTION, USE OF EXPIRED PRODUCT IS AN OFF-LABEL USE OF THE DEVICE. AT THIS POINT, THERE ARE NO INDICATIONS FOR ANY DEVICE RELATED PROBLEMS. DEVICE STILL IMPLANTED IN PATIENT.

    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.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT ONE EXPIRED SCREW AND PLATE WAS IMPLANTED IN PATIENT. THE EXPIRATION DATE WAS NOTICED WHEN THE IMPLANT STICKER WAS BEING TRANSFERRED TO THE OPERATIVE NOTES. THE SURGEON WAS NOTIFIED AS THE PATIENT WAS STILL ON THE TABLE. HOWEVER, THE SURGEON DECIDED TO GO AHEAD AND CLOSE THE PATIENT. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED SO FAR.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT ONE EXPIRED SCREW AND PLATE WAS IMPLANTED IN PATIENT. THE EXPIRATION DATE WAS NOTICED WHEN THE IMPLANT STICKER WAS BEING TRANSFERRED TO THE OPERATIVE NOTES. THE SURGEON WAS NOTIFIED AS THE PATIENT WAS STILL ON THE TABLE. HOWEVER, THE SURGEON DECIDED TO GO AHEAD AND CLOSE THE PATIENT. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245126 BONE SCREW, CROSS-PIN, SELF-TAPPING, DIAM.1.2X6MM, UPPERFACE, STERILE, (1/PACKAG SCREW JEY STRYKER OSTEOSYNTHESIS-FREIBURG J3K01F83QP

    Patients

    Seq Age Sex Outcome Treatment
    1