INION OTPS¿

Additional Manufacturer Narrative

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

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.