BEUDAMED
    FDA Adverse Event Other Summary report: N

    X STOP IPD SYSTEM

    MDR report key: 799201 · Received December 21, 2006

    Report

    Report Number
    2953720-2006-00017
    Event Type
    Other
    Date Received
    December 21, 2006
    Report Date
    November 21, 2006
    Manufacturer
    ST. FRANCIS MEDICAL 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

    METHOD: DEVICE NOT RETURNED. RESULTS: UNABLE TO OBTAIN ADDITIONAL INFO FROM FACILITY. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    PT UNDERWENT SURGICAL PROCEDURE, AT WHICH TIME X STOP IMPLANTS WERE INSERTED AT TWO LEVELS; SURGEON ALSO PERFORMED A LAMINOTOMY AT L2/L3. PT WAS PLACED IN PRONE POSITION. DURING THE PROCEDURE, A SPINOUS PROCESS FRACTURE OCCURRED AT L4; THE SURGEON ELECTED TO INSERT THE IMPLANT AS PLANNED AND BRACE THE PT POSTOPERATIVELY AS A PRECAUTION. NO ADDITIONAL INFO REGARDING THIS INCIDENT IS AVAILABLE.

    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. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention