BEUDAMED
    FDA Adverse Event Other Summary report: N

    X STOPPK IPD SYSTEM

    MDR report key: 799210 · Received December 21, 2006

    Report

    Report Number
    2953720-2006-00013
    Event Type
    Other
    Date Received
    December 21, 2006
    Date of Event
    September 11, 2006
    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

    H6: METHOD: DEVICE NOT RETURNED. RESULTS, CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. ADD'L LOT NUMBER IS 051205.

    Description of Event or Problem · 1

    X-RAY REVEALED DISLOCATION OF BOTH X - STOP IMPLANTS. PT UNDERWENT REVISION SURGERY TO REMOVE IMPLANTS. PT REPORTEDLY HAD SIGNIFICANT FACET JOINT HYPERTROPHY NEARLY FUSED; WHICH WAS LIKELY CAUSAL TO THE INCIDENT.

    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. 1-3010 051214

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention