Inion FreedomPin™ 1 (REF OPK-15K2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06438408004346), received between Apr 2, 2025 and Apr 2, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 56-YEAR-OLD FEMALE WITH HYPERTENSION UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF A TIBIA AND FIBULA FRACTURE. BOTH METAL IMPLANTS AND ABSORBABLE INION FREEDOMPINS (INION FREEDOMPIN¿ KIT Ø1.5 MM AND INION FREEDOMPIN¿ KIT Ø2.0 MM (REPORTED SEPARATELY) WERE USED IN THE FIXATION. THE PATIENT WAS DISCHARGED SUCCESSFULLY. APPROXIMATELY 1 YEAR LATER THE PATIENT WAS RE-ADMITTED TO HOSPITAL WITH POOR WOUND HEALING. BASED ON THE INFORMATION RECEIVED, DESPITE INITIAL WOUND HEALING THE WOUND STARTED TO HAVE SYMPTOMS APPROXIMATELY 10 DAYS PRIOR TO THE RE-ADMISSION TO HOSPITAL (1 YEAR AFTER THE ORIGINAL OPERATION), BACTERIAL CULTURES WERE TAKEN AND BACTERIA WAS FOUND. THE PATIENT WAS TREATED WITH ANTIBIOTICS, DEBRIDEMENT AND INTERNAL FIXATION REMOVAL OF METAL IMPLANTS. THE PATIENT WAS DISCHARGED AFTER WOUND HEALING. THE INION FREEDOMPIN IMPLANTS WERE NOT REMOVED AND BASED ON THE INFORMATION RECEIVED BY INION, THE FRACTURES HAVE HEALED.

  Patient problems: Bacterial Infection; Post Operative Wound Infection

  MAUDE report 21750731 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 50-YEAR-OLD MALE PATIENT WITH NO UNDERLYING DISEASES UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION FOR ANKLE FRACTURE (LEFT TRIMALLEOLAR FRACTURE, DISLOCATION AND LIGAMENT INJURY). INION FREEDOMPINS WERE USED IN THE FIXATION TOGETHER WITH METAL IMPLANTS. THE OPERATION WAS SUCCESSFUL. 3 WEEKS AFTER INITIAL OPERATION THE PATIENT WAS RE-ADMITTED TO A HOSPITAL WITH POSTOPERATIVE WOUND INFECTION. BACTERIAL CULTURES WERE TAKEN AND BACTERIA WAS FOUND. THE TREATMENT FOR THE WOUND INFECTION INCLUDED ANTIBIOTICS, DEBRIDEMENT AND FLAP TRANSFER. THE WOUND HEALED AFTER DEBRIDEMENT AND FLAP TRANSFER AND THE PATIENT WAS DISCHARGED. NO IMPLANT REMOVALS WERE NECESSARY (EITHER METAL IMPLANTS OR INION FREEDOMPINS). THE TRIMALLEOLAR FRACTURE HAS BEEN HEALED.

  Patient problems: Bacterial Infection; Post Operative Wound Infection

  MAUDE report 21750349 ↗