BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION S-1 GRAFT CONTAINMENT SYSTEM PLATE

    MDR report key: 1328973 · Received February 19, 2009

    Report

    Report Number
    9710629-2009-00001
    Event Type
    Injury
    Date Received
    February 19, 2009
    Date of Event
    November 11, 2008
    Report Date
    January 27, 2009
    Manufacturer
    INION OY
    Product Code
    OJB
    PMA / PMN Number
    K071810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRIMARY AIM OF THE PROCEDURE I.E., SOLID FUSION WAS SUCCESSFULLY ACHIEVED, BUT RE-OPERATION WAS NEEDED 1.5 YEARS POST-OPERATIVELY TO SOLVE THE SWALLOWING PROBLEMS CAUSED BY MATERIAL DEGRADATION RELATED LOCAL SOFT TISSUE REACTION / FLUID ACCUMULATION (ADVERSE EVENT / ANTICIPATED RISK). IT SHOULD BE NOTED THAT SEVERAL FOREIGN MATERIALS WERE USED TOGETHER IN THESE PROCEDURES (BIODEGRADABLE POLYMER, PEEK, AND BETA-TRICALCIUM PHOSPHATE). THE DEGRADATION RELATED TISSUE REACTIONS TYPICALLY OCCUR EARLIEST APPROX 1.5 - 2 YRS POSTOPERATIVELY, I.E., WHEN THE IMPLANT DEGRADES, WHICH IS MOST LIKELY THE CAUSE OF THE MASSES SEEN. PLEASE NOTE THE FOLLOWING STATEMENTS IN THE INSTRUCTION FOR USE IN THE INION S-1 SYSTEM: IMPLANTATION OF FOREIGN MATERIALS CAN RESULT IN AN INFLAMMATORY RESPONSE OR ALLERGIC REACTION. TRANSIENT LOCAL FLUID ACCUMULATION MAY OCCUR IN STERILE CIRCUMSTANCES. MORE THAN 2000 INION S-1 PLATES HAVE BEEN SOLD SINCE THE PRODUCT WAS LAUNCHED 2005/2006. IDENTICAL CASES NOT PREVIOUSLY REPORTED TO INION.

    Description of Event or Problem · 1

    ACDF, C5-6. SOLID FUSION, BUT SWALLOWING DIFFICULTIES, ABNORMAL CYSTIC MASS (SAME SHAPE AND SIZE AS THE PLATE) AND LIQUID FORMATION 1.5 YEARS POST-OPERATIVELY. RE-OPERATION PERFORMED FOR CYST REMOVAL (INFLAMMATORY TISSUE). PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION S-1 GRAFT CONTAINMENT SYSTEM PLATE OJB: SPINAL INTERVERT. BODY FIXATION ORTH OJB INION OY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O (BACITRACIN SOLUTION)| WOUND IRRIGATED WITH ANTIBIOTIC SOLUTION| 9MM PEEK SPACER WITH VITOSS SATURATED WITH BMA.