BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 2171774 · Received July 22, 2011

    Report

    Report Number
    2953769-2011-00088
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: FOLLOW-UP WITH COMPANY REPRESENTATIVE. EVALUATION SUMMARY: VISUAL AND FUNCTIONAL INSPECTION INDICATED: "THE LOCKING SCREW WAS BROKEN APPROXIMATELY AT THE JUNCTION BETWEEN THE SMOOTH SHAFT AND THREADED PORTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN X-STOP PROCEDURE AT LEVEL L2/L3 ON (B)(6) 2011. PATIENT BEGAN HAVING INCREASING PAIN. PATIENT HAD POSTOP EXAMINATION ON (B)(6) 2011, AND AT THAT TIME, RADIOGRAPHS WERE OBTAINED AND THE X-STOP WAS NO LONGER CONNECTED. IT WAS DECIDED THAT A REVISION WAS REQUIRED. THE DEVICE WAS EXPLANTED ON (B)(6) 2011. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP IPD SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SPINE LLC. 2232411

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Other