BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2883590 · Received December 21, 2012

    Report

    Report Number
    2520274-2012-04291
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 26, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    MAUDE EVENT REPORT RECEIVED INDICATES PATIENT WAS IMPLANTED WITH A MATRIX CONSTRUCT ON (B)(6) 2011, LEVELS TREATED ARE UNKNOWN. IN 2012, THERE WAS INDICATION IN AN X-RAY THAT THE LEFT ROD HAD STARTED TO MOVE BUT NO BREAK COULD BE SEEN. A LATER X-RAY IN 2012 SHOWS THE ROD BROKEN AND UPWARD MOVEMENT HAD OCCURRED. ANOTHER X-RAY ON AN UNKNOWN DATE SHOWED A COMPLETE FAILURE OF THE ROD AND TWO CAPS WHICH ALLOWED THE ROD TO MOVE UPWARD INTO THE BACK MUSCLES. NOW THERE IS NOTHING TO RESTRAIN THE IMPLANTS FROM MOVING AND IS NOW REQUIRING REVISION SURGERY. THE SURGEON HAS ADVISED THAT THE MIGRATION OF A ROD INTO THE BACK MUSCLES WILL CONTINUE TO CAUSE FURTHER DAMAGE IF LEFT IN PLACE. REVISION PROCEDURE HAS NOT BEEN SCHEDULED. THIS REPORT IS #5 OF 5 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW SCREW NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS, ROD, CAPS