BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION CPS 2.0 MM SYSTEM X-PLATE

    MDR report key: 2559471 · Received April 30, 2012

    Report

    Report Number
    9710629-2012-00001
    Event Type
    Injury
    Date Received
    April 30, 2012
    Manufacturer
    INION OY
    Product Code
    JEY
    PMA / PMN Number
    K010351
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREFERRED TECHNIQUE FOR GENIOPLASTY IS FIXATION WITH 2 INION CPS 2.5 SCREWS AS PRESENTED IN THE INION CPS TRAINING MATERIAL. SINCE 2001, 2 CASES HAVE BEEN EVALUATED BY INION BEFORE, THUS OCCURRENCE RATE VERY LOW. ALTHOUGH THESE PROBLEMS ARE VERY RARE, THE IMPLANT SELECTION SECTION IN THE IFU IS PLANNED TO BE UPDATED TO INCLUDE THIS MORE SPECIFIC INFO. THE INION CPS IFU STATES UNDER WARNINGS: INCORRECT SELECTION, PLACEMENT, POSITIONING, AND FIXATION OF THE IMPLANT CAN CAUSE SUBSEQUENT UNDESIRABLE RESULTS. THE SURGEON SHOULD BE FAMILIAR WITH THE DEVICES, THE METHOD OF APPLICATIONS AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING THE SURGERY.

    Description of Event or Problem · 1

    DURING A COMPARATIVE STUDY, SURGEON USED X-PLATE WITH 4 SCREWS IN OSSEOUS ADVANCED GENIOPLASTY. 4 OUT OF 5 PATIENTS BETWEEN AGE OF (B)(6) EXPERIENCED SIMILAR PROBLEM WHICH LED TO RE-OPERATION AND REPLACEMENT WITH TITANIUM PLATE. WITHIN 6-24 HOURS POSTOPERATIVELY, X-PLATE WAS FIXED IN PLACE BUT LOST HARDNESS AND NO STABILITY, AND THE FREE SEGMENTAL CHIN MOVED BACK. NO PROBLEMS WERE OBSERVED WHEN THE SAME OPERATION WAS DONE TO 7 OTHER PATIENTS USING 2 PCS OF 2.5 MM X 19 MM LAG SCREW (PRESUMABLY SCR-1294 2.5 X 18 MM SCREW). OTHER 3 PATIENTS WERE 1 MALE, 2 FEMALE, AGE 20, 23, 25. DEMOGRAPHICS ARE NOT AVAILABLE INDIVIDUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS 2.0 MM SYSTEM X-PLATE BOEN PLATE JEY INION OY PLT-1039/PLT-1040 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention INION CPS 2.0 MM X 11 MM SCREWS FOR PLATE FIXATION| (4 EACH)