BEUDAMED
    FDA Adverse Event Other Summary report: N

    X STOP IPD SYSTEM

    MDR report key: 788118 · Received November 17, 2006

    Report

    Report Number
    2953720-2006-00006
    Event Type
    Other
    Date Received
    November 17, 2006
    Date of Event
    October 6, 2006
    Report Date
    November 17, 2006
    Manufacturer
    ST. FRANCIS MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6. METHOD: DEVICE NOT RETURNED. RESULTS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. CONCLUSION: FOLLOWING REVISION SURGERY, A LOW WHITE BLOOD CELL COUNT AND SUSPECTED INFECTION WERE REPORTED. APPROXIMATELY THREE WEEKS AFTER THE REPORT OF SUSPECTED INFECTION, THE TREATING PHYSICIAN REPORTED THAT PATIENT HAD RETURNED TO CLINIC WITH NO SIGN OF INFECTION AND NO COMPLAINTS OF PAIN.

    Description of Event or Problem · 1

    TWO 12MM X STOP INTERSPINOUS DECOMPRESSION SPINAL IMPLANTS WERE INSERTED AT L2-3 AND L3-4. IT WAS REPORTED THAT THE SURGEON EXPERIENCED DIFFICULTY PLACING IMPLANT AT L2-3 DUE TO SPINAL ANATOMY, AND THAT POSTOPERATIVELY, PATIENT COMPLAINED OF PAIN. APPROXIMATELY TWO WEEKS AFTER INITIAL SURGERY, THE 12MM IMPLANT AT L2-3 WAS EXPLANTED AND A 14MM IMPLANT WAS INSERTED AT L4-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X STOP IPD SYSTEM INTERSPINOUS PROCESS PROSTHESIS NQO ST. FRANCIS MEDICAL DEVICE TECHNOLOGIES, INC. NA 060927

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention