BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1162443 · Received September 16, 2008

    Report

    Report Number
    2953769-2008-00042
    Event Type
    Injury
    Date Received
    September 16, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD- OTHER; ROUTINE LITERATURE SEARCH. THE FILLING OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT ANY DEVICE DISCUSSED HEREIN CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 1

    DURING A CLINICAL LITERATURE REVIEW, THERE WAS NO INDICATION OF THE OCCURRENCE OF A SPINOUS PROCESS FRACTURE DURING AN X-STOP PROCEDURE REPORTED. NO OTHER INFO WAS AVAILABLE AT THIS TIME.

    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