BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1841528 · Received September 14, 2010

    Report

    Report Number
    2953769-2010-00390
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 26, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "ASSOCIATION BETWEEN DEGENERATIVE SPONDYLOLISTHESIS AND SPINOUS PROCESS FRACTURE FOLLOWING INTERSPINOUS PROCESS SPACER SURGERY", BY DAVID H. KIM, MD, NAEL SHANTI, MD, MARK TANTORSKI, DO, JEREMY SHAW, BA, LING LI, MSPH, JULI F. MARTHA, MPH, ADRIAN THOMAS, MD, STEPHEN PARAZIN, MD. METHOD; DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ABSTRACT TITLED "ASSOCIATION BETWEEN DEGENERATIVE SPONDYLOLISTHESIS AND SPINOUS PROCESS FRACTURE FOLLOWING INTERSPINOUS PROCESS SPACER SURGERY", THE FOLLOWING WAS REPORTED: OUT OF 38 PATIENTS WHO UNDERWENT INTERSPINOUS PROCESS SPACER (IPS) SURGERY AT A TOTAL OF 50 LEVELS (38 AT LEVEL L4-5, 12 L3-4; 26 1-LEVEL, 12 2-LEVEL) 11 SPINOUS PROCESS FRACTURES WERE IDENTIFIED BY CT IN 11 PATIENTS (22.0% OF LEVELS). IMPLANTS INCLUDED 34 TITANIUM X-STOP (MEDTRONIC), 8 PEEK X-STOP (MEDTRONIC), AND 8 ASPEN (LANX) DEVICES. IT IS UNK HOW MANY SPINOUS PROCESS FRACTURES OCCURRED IN THE PATIENT'S TREATED WITH MEDTRONIC X-STOP DEVICES. NO ADDITIONAL INFORMATION WAS REPORTED.

    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 UNK Other