BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    MDR report key: 4283333 · Received November 18, 2014

    Report

    Report Number
    9710629-2014-00002
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 24, 2014
    Manufacturer
    INION OY
    Product Code
    HRS
    PMA / PMN Number
    K063410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INION FREEDOMSCREWS WERE USED FOR THE FIXATION OF INION FREEDOMPLATE. INION FREEDWOMSCREW COMMON DEVICE NAME: BONE SCREW. INION FREEDOMSCREW 510(K) NUMBER: K123672.

    Description of Event or Problem · 1

    (B)(6), PERFORMED 19 OPERATIONS USING INION FREEDOM PLATE AND INION FREEDOMSCREW - FIXATION (SCREW SIZE PRIMARILY 3.5 MM). HEALING WAS UNEVENTFUL AFTER MAJORITY OF THE OPERATIONS BUT IN ONE CAUSE THE FIXATION PROVED TO BE NON-STABLE AND RESULTED IN PSEUDOARTHROSIS. A REOPERATIONS WAS NECESSARY AND INION IMPLANTS WERE REPLACED BY METAL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745813 INION OTPS BIOABSOBABLE FREEDOMPLATE BONE PLATE HRS INION OY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention