BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2953769-2011-00026

    MDR report key: 2032909 · Received March 29, 2011

    Report

    Report Number
    2953769-2011-00026
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE FOLLOWING WAS OBSERVED ON THE RETURNED DEVICE DURING VISUAL INSPECTION: THERE WAS NO DAMAGE TO THE HANDLES OR SHAFT. THE TORQUE RESET MECHANISM WAS NOT DAMAGED. THE TIP WAS UNABLE TO BE ARTICULATED AT 45° AND 90°. THE PIVOT WAS OBSERVED DISCONNECTED FROM BOTH WELD JOINTS. CONCLUSION: BASED ON VISUAL INSPECTION, THE HEAD OF THE ASSEMBLY WAS SPLAYED; THUS, PREVENTED THE ASSEMBLY BEING REMOVED FROM THE DOCKED CANNULA. THE REPORTED FAILURE MODE IN THE COMPLAINT IS CONSISTENT WITH THE INVESTIGATION RESULTS. METHOD; FOLLOWED UP WITH COMPANY REPRESENTATIVE. MEDTRONIC, INC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: AN EXPRESS CURETTE WAS USED TO SCORE SCLEROTIC BONE AT L4 DURING A KYPHOPLASTY CASE. WHEN ATTEMPTING TO REMOVE THE CURETTE FROM THE LEFT SIDE, THE CURETTE WOULD NOT PULL OUT OF THE WORKING CANULA. THE ENTIRE LEFT CANULA HAD TO BE REMOVED WITH THE EXPRESS CURETTE. WHEN REMOVED, THE TIP OF THE CURETTE APPEARED TO BE BENT. THE CASE THEN HAD TO BE COMPLETED FROM A UNILATERAL APPROACH THERE WERE NO FRAGMENTS LEFT IN THE PATIENT AND NO ADVERSE EVENTS. THE CASE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LXH MEDTRONIC SPINE LLC 0005522072

    Patients

    Seq Age Sex Outcome Treatment
    1