BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN¿ SPINAL SYSTEM

    MDR report key: 2859062 · Received December 5, 2012

    Report

    Report Number
    1030489-2012-02560
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 22, 2012
    Report Date
    February 20, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7968214, PRODUCT CODE MAX WAS CLEARED IN THE UNITED STATES. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7968214, 510K # K091813 WAS CLEARED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: VISUAL AND OPTICAL ANALYSIS OF THE RETURNED DEVICE SHOWS THAT CRACKING APPEARS TO HAVE INITIATED NEAR THE INTERSECTION OF THE OUTER WALL AND THE SCREW BOSS HOLE WHERE THE SHARP CORNER COULD ACT AS A STRESS RISER. OPTICAL EXAMINATION IDENTIFIED PLASTIC DEFORMATION ON THE INTERIOR AND OUTER EDGE OF THE SCREW BOSS HOLE, CONSISTENT WITH AXIAL MISALIGNMENT OF THE BONE SCREW DURING IMPLANTATION, WHICH COULD RESULT IN OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE SCREW DURING IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT WHILE INSERTING THE SCREW, THE CAGE FRACTURED INTO PIECES. THE BROKEN PIECES WERE REMOVED AND A NEW CAGE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH 202603269

    Patients

    Seq Age Sex Outcome Treatment
    1