Inion FreedomPin™ 1 (REF OPA-1550)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06438408004155), received between Jul 14, 2025 and Jul 14, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  A 6-YEAR-OLD MALE PATIENT WITH BIG TOE FRACTURE (PROXIMAL PHALANG) WAS OPERATED WITH INION FREEDOMPIN Ø1,5 MM. 2 YEARS AFTER OPERATION PATIENT SUFFERED OF REDNESS & SWELLING OF THE IP-JOINT. X-RAY, MRI, LABORATORIES (LEUK, CRP) WERE TAKEN. LABORATORY RESULTS WERE NORMAL. IN MRI THE PIN WAS PARTIALLY ABSORBED, DISTAL PART STILL INSIDE THE PHALANGE. THERE WAS EDEMA AROUND THE PIN COVERING THE WHOLE PHALANGE WHICH LED THE SURGEON TO SUSPECT ROOT CAUSES SUCH AS OSTEOMYELITIS/ARTHRITIS AND FOREIGN BODY REACTION. PATIENT HAD ANTIBIOTICS FOR 10 DAYS, HOWEVER NO SAMPLES TAKEN, BECAUSE THE PATIENT HAD NO FEVER, OR PAIN IN THE TOE AND LABORATORY SAMPLES WERE NORMAL. THE SWELLING DISAPPEARED IN A MONTH. RE-OPERATION WAS NOT NEEDED. X-RAY 4 MONTHS LATER SHOWED A LARGE EROSION (LYTIC LESION) INSIDE THE FIRST PHALANGE. X-RAYS AND MRI WERE SENT TO UNIVERSITY HOSPITAL FOR FURTHER EXAMINATIONS IF NEEDED. PATIENT'S CURRENT CONDITION IS NORMAL.

  Patient problems: Inflammation

  MAUDE report 22492918 ↗