BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION OTPS MINI PLATING SYSTEM

    MDR report key: 1637746 · Received March 19, 2010

    Report

    Report Number
    9710629-2010-00003
    Event Type
    Injury
    Date Received
    March 19, 2010
    Report Date
    March 18, 2010
    Manufacturer
    INION OY
    Product Code
    MAI
    PMA / PMN Number
    K023887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE REPORTED POSTOPERATIVE PLATE LOOSENING NECESSITATED A RE-OPERATION OR NOT, BUT IT IS ASSUMED SO. ALSO IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF THIS INCIDENT WITHOUT MORE INFORMATION ABOUT THE CASE. IF SUCH INFORMATION WILL BE RECEIVED, A FOLLOW-UP REPORT WILL BE SENT TO COMPLETE THIS REPORT. METHOD: THE DEVICE COULD NOT BE EVALUATED BY ANY METHOD. ONLY THE RECEIVED INFORMATION WAS EVALUATED. RESULTS: NOT ENOUGH INFORMATION ABOUT THE CASE.

    Description of Event or Problem · 1

    ACCORDING TO THE RECEIVED INFORMATION, SURGEON PERFORMED AN OPERATION USING INION OTPS BIODEGRADABLE MINI HAND PLATES AND INION OTPS 2.0 MM SCREWS, AND THE PLATES HAD LOOSENED POSTOPERATIVELY. IN SPITE OF REQUESTS, NO MORE INFORMATION OF THE CASE, SUCH AS POSSIBLE RE-OPERATION OR PATIENT OUTCOME HAS BEEN RECEIVED. IT IS ALSO NOT KNOWN WHETHER APPROPRIATE IMMOBILIZATION WAS USED. NEVERTHELESS, THE EVENT IS REPORTED BASED ON ASSUMPTION THAT A RE-OPERATION WAS CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION OTPS MINI PLATING SYSTEM BONE PLATE, BONE SCREW, BIODEGRADABLE MAI INION OY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention