BEUDAMED
    FDA Adverse Event Other Summary report: N

    X STOPPK IPD SYSTEM

    MDR report key: 799195 · Received December 21, 2006

    Report

    Report Number
    2953720-2006-00016
    Event Type
    Other
    Date Received
    December 21, 2006
    Date of Event
    December 1, 2005
    Report Date
    December 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. RESULTS AND CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. ADD'L LOT NUMBER IS 051104.

    Description of Event or Problem · 1

    THREE MONTHS POST-OPERATIVELY, PT COMPLAINED OF LOWER BACK PAIN AND NUMBNESS IN RIGHT LEG. X-RAY SHOWED EVIDENCE OF A 2MM IMPLANT MIGRATION POSTERIORLY. AT 8 MONTHS POSTOPERATIVELY, X-RAY CONFIRMED A L4 SPINOUS PROCESS FRACTURE. PT UNDERWENT REVISION SURGERY TO REMOVE IMPLANTS AND PERFORM 3-LEVEL PEDICLE SCREW FIXATION IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X STOPPK IPD SYSTEM INTERSPINOUS PROCESS PROSTHESIS NQO ST. FRANCIS MEDICAL TECHNOLOGIES, INC. 1-3016 050531

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R