BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1603742 · Received February 10, 2010

    Report

    Report Number
    2953769-2010-00035
    Event Type
    Injury
    Date Received
    February 10, 2010
    Date of Event
    June 22, 2009
    Report Date
    January 16, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "THE SANDWICH PHENOMENON": A RARE COMPLICATION IN ADJACENT, DOUBLE-LEVEL X-STOP SURGERY", BY GIUSEPPE M. V. BARBAGALLO, MD, LEONARDO A. CORBINO, MD, GIUSEPPE OLINDO, MD, PIETRO FOTI, MD, VINCENZO ALBANESE, MD, AND FRANCESCO SIGNORELLI, MD. ADD'L CATALOG #: 1-3012. DEVICE NOT RETURNED, FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "THE SANDWICH PHENOMENON": A RARE COMPLICATION IN ADJACENT, DOUBLE-LEVEL X-STOP SURGERY, THE FOLLOWING EVENT WAS REPORTED: PATIENT 3: A PATIENT UNDERWENT A TWO LEVELS X-STOP PROCEDURE AT L3/L4 AND L4/L5, WITHOUT EXPERIENCING ANY INTRAOPERATIVE COMPLICATION. AFTER SURGERY, A SIGNIFICANT CLINICAL IMPROVEMENT LASTER FOR ABOUT 18 MONTHS, THE PATIENT PRESENTED BECAUSE OF RECURRENT SYMPTOMS. PATIENT DENIED HAVING SUSTAINED TRAUMAS OR HAVING PERFORMED PHYSICAL "STRENUE ACTIVITIES". UPDATED IMAGING DEMONSTRATED THE L4 SPINOUS PROCESS FRACTURE WITH DEVICES DISLOCATION. HOWEVER, THE PATIENT REFUSED FURTHER SURGERY AND WAS TREATED CONSERVATIVELY. NO ADDITIONAL INFORMATION WAS REPORTED. CASE REPORTS PRESENTED FOR PATIENT 1 AND PATIENT 2 WERE PREVIOUSLY FILED AS 2953720-2006 00014 AND 2953720-2006-00016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP IPD SYSTEM INTERSPINOUS PROCESS SPACER NQO MEDTRONIC SPINE LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other