BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1902589 · Received November 17, 2010

    Report

    Report Number
    2953769-2010-00556
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    June 12, 2008
    Report Date
    September 23, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE WAS NOT RETURNED; FOLLOWED UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6), PATIENT UNDERWENT AN X-STOP PROCEDURE. THE PATIENT HAD A SUPERFICIAL DRAINAGE OF A SMALL AREA AT THE INCISIONAL SITE WHICH REQUIRED FURTHER INCISION AND DRAINAGE. RESOLUTION WAS IN APPROXIMATELY TWO MONTHS. 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