BEUDAMED
    FDA Adverse Event Other Summary report: N

    X STOP IPD SYSTEM

    MDR report key: 731439 · Received June 30, 2006

    Report

    Report Number
    2953720-2006-00001
    Event Type
    Other
    Date Received
    June 30, 2006
    Date of Event
    May 25, 2006
    Report Date
    June 30, 2006
    Manufacturer
    ST. FRANCIS MEDICAL TECHNOLOGIES, INC.
    Product Code
    NQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A X STOP INTERSPINOUS DECOMPRESSION SPINAL IMPLANT WAS INSERTED BETWEEN LEVEL L4 AND L5 IN EARLY 2006. APPROXIMATELY 4 MONTHS LATER, IT WAS REPORTED THAT THE IMPLANT WAS REMOVED; MOST LIKELY DUE TO DEVICE DISLODGEMENT. THE PATIENT CONCURRENTLY UNDERWENT SPINAL FUSION SURGERY AT THE TIME OF DEVICE REMOVAL. THE DATE OF DEVICE DISLODGEMENT IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X STOP IPD SYSTEM INTERSPINOUS PROCESS PROSTHESIS NQO ST. FRANCIS MEDICAL TECHNOLOGIES, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention