BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION OTPS¿

    MDR report key: 23494213 · Received November 7, 2025

    Report

    Report Number
    3003407235-2025-00014
    Event Type
    Injury
    Date Received
    November 7, 2025
    Report Date
    October 13, 2025
    Manufacturer
    INION OY
    Product Code
    HTY
    PMA / PMN Number
    K050275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RISK OF TISSUE IRRITATION IS ALWAYS PRESENT WHEN FOREIGN MATERIALS ARE IMPLANTED (E.G. DUE TO MECHANICAL IRRITATION, HYPERSENSITIVITY TO FOREIGN MATERIALS). MECHANICAL IRRITATION, INFECTION AND TISSUE REACTION ARE ALSO IDENTIFIED AS ADVERSE POST-OP REACTIONS OF INION FREEDOM/OTPS IMPLANTS. ACCORDING TO LONG-TERM PMS DATA OF INION FREEDOM/OTPS SYSTEM A COMPLICATION-TO OPERATION RATIO FOR "SYMPTOMATIC FOREIGN BODY REACTION GREATER THAN OR EQUAL TO 3 MONTHS POST-OPERATIVELY (INFLAMMATION, SWELLING, PALPABILITY, MECHANICAL IRRITATION)" IS (B)(4).

    Description of Event or Problem · 0

    IN THE PUBLICATION KOMUR ET AL. 2018 (MID-TERM RESULTS OF TWO DIFFERENT FIXATION METHODS FOR CHEVRON OSTEOTOMY FOR CORRECTION OF HALLUX VALGUS) 40 PATIENTS (48 FEET) WERE TREATED WITH INION OTPS BIOABSORBABLE PINS FOR CHEVRON OSTEOTOMY / HALLUX VALGUS, AND COMPARED WITH CANNULATED METAL SCREW FIXATION. THREE INION OTPS BIOABSORBABLE PIN REMOVAL OPERATIONS WERE CONDUCTED FOR 3/40 (7.5%) CHEVRON OSTEOTOMY PATIENTS WITHIN THE STUDY. THE REMOVALS WERE DONE DUE TO IRRITATION DURING THE FOLLOW-UP PERIOD OF THE STUDY (14 (RANGE 2 TO 27) MONTHS). THE IRRITATION INCIDENTS ARE BEING REPORTED (THREE REPORTS, EACH PATIENT REPORTED SEPARATELY) AS THEY RESULTED IN PIN REMOVAL SURGERY. THE REMOVAL SURGERIES WERE CONDUCTED AFTER BONE HEALING AND THE STUDY REPORTS THAT NO LOSS OF CORRECTIONS WERE NOTICED WITH ANY OF THE STUDY PATIENTS. THE AUTHORS CONCLUDED THAT BOTH METHODS (BIOABSORBABLE PINS AND METAL SCREWS) WERE FOUND SAFE AND RELIABLE AFTER CHEVRON OSTEOTOMY FOR CORRECTION OF HALLUX VALGUS UNDER APPROPRIATE CONDITIONS AND WHEN PERFORMED BY AN EXPERIENCED SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860693 INION OTPS¿ PIN HTY INION OY

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown Required Intervention