BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1828222 · Received September 3, 2010

    Report

    Report Number
    2953769-2010-00372
    Event Type
    Injury
    Date Received
    September 3, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 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

    CATALOG #: 1-2210, LOT #: 2180331, EXPIRATION DATE: 07/31/2011. DEVICE MANUFACTURING DATE: 07/2009. H6: METHOD: DEVICE WAS NOT RETURNED; FOLLOWED UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN X-STOP PROCEDURE AT THREE LEVELS L2-L5. THE 10 MM DEVICE WAS SUCCESSFULLY INSERTED AT LEVEL L4/L5. DURING INSERTION OF THE 8 MM DEVICE, THE SPINOUS PROCESS WAS FRACTURED AT LEVEL L4. BOTH DEVICES WERE REMOVED AND LAMINECTOMIES WERE PERFORMED. IT WAS NOTED THAT THERE WAS 1.5 HOUR DELAY IN THE OVERALL PROCEDURE TIME AND IN-PATIENT HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION WAS NECESSARY. NO ADDITIONAL INFO 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 2186081

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention