Inion FreedomScrew™ 1 (REF OSC-4555)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06438408003592), received between Jun 25, 2024 and Apr 29, 2025 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADULT MALE PATIENT WITH NO UNDERLYING DISEASES OR MEDICATIONS SUFFERED FROM POOR WOUND HEALING AFTER ANKLE FRACTURE FIXATION WITH 3 INION FREEDOMSCREWS AND METAL IMPLANTS. POOR WOUND HEALING SYMPTOMS APPEARED APPROXIMATELY 2 MONTHS AFTER INITIAL OPERATION. NO INFORMATION IS AVAILABLE IF THE POST-OPERATIVE WOUND CARE WAS LOOKED AFTER BY THE PATIENT IN ACCORDANCE WITH THE GIVEN POSTOPERATIVE INSTRUCTIONS. NO BACTERIAL CULTURES WERE TAKEN. SYMPTOMATIC MANAGEMENT INCLUDING WOUND DRESSING CHANGES AND ANTI-INFLAMMATORY THERAPY SHOWED INADEQUATE EFFICACY. THE WOUND WAS REPEATEDLY IRRIGATED WITH HYDROGEN PEROXIDE AND SALINE. FINALLY, APPROXIMATELY 3 MONTHS AFTER INITIAL OPERATION, DEBRIDEMENT AND INTERNAL FIXATION REMOVAL WAS PERFORMED, BOTH METAL IMPLANTS AND INION FREEDOMSCREWS WERE REMOVED. WOUND HEALED AFTER DEBRIDEMENT AND INTERNAL FIXATION REMOVAL AND BASED ON INFORMATION PROVIDED BY THE HOSPITAL, ALSO THE FRACTURE HEALED SATISFACTORILY.

  Patient problems: Impaired Healing

  MAUDE report 21924357 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BILATERAL CALCANEAL FRACTURES OF 42-YEAR-OLD MALE PATIENT WERE FIXED WITH INION FREEDOMSCREW OSC-4555 LOT 2306024 TOGETHER WITH OTHER IMPLANTS FROM OTHER MANUFACTURERS (NOT SPECIFIED). THE PATIENT'S PAIN STARTED TO WORSEN AFTER HE STARTED WALKING 3 MONTHS POSTOPERATIVELY, AND THE PATIENT FELT THE PAIN INTERFERED WITH HIS NORMAL LIFE. 3,5 MONTHS AFTER THE OPERATION THE PATIENT WAS ADMITTED TO HOSPITAL WITH DIAGNOSIS OF PAIN IN THE POSTOPERATIVE RECOVERY PERIOD OF LEFT HEEL FRACTURE. AT THIS POINT THE CALCANEAL FRACTURE HAD ALREADY BEEN OSSIFIED. PRP (PLATELET-RICH-PLASMA) INJECTION WAS GIVEN TO THE LEFT CALCANEUS TOGETHER WITH OTHER SYMPTOMATIC SUPPORTIVE TREATMENT, AND IT HELPED WITH THE PATIENT'S SYMPTOMS. NO IMPLANT REMOVAL OPERATIONS HAVE BEEN PERFORMED TO THE PATIENT. BASED ON ADDITIONAL INFORMATION RECEIVED, THE PATIENT ALSO SUFFERED A WOUND INFECTION AT SOME POINT DURING POSTOPERATIVE PERIOD, WHICH WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Impaired Healing; Pain; Unspecified Infection

  MAUDE report 20308209 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BASED ON THE INFORMATION RECEIVED BY INION, 38 YEAR-OLD MALE PATIENT SUFFERING FROM TYPE 2 DIABETES HAD INTERNAL FIXATION WITH INCISION AND REDUCTION OF RIGHT ANKLE FRACTURE USING INION FREEDOMSCREW¿ 4.5 X 55 MM, CANNULATED (OSC-4555, LOT 2307022). SURGERY WAS PERFORMED UNDER GENERAL ANESTHESIA, THE FRACTURE OF FIBULA WAS FIXED WITH A BONE GRAFTING PLATE AND THE LOWER TIBIAL FIBULA WAS FIXED WITH RESORBABLE SCREWS, AND THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT DISCHARGED. 1,5 MONTHS AFTER THE OPERATION REDNESS, SWELLING, AND OOZING OF FLUID APPEARED IN THE WOUND. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR DEBRIDEMENT, ALSO ANTIBIOTICS WERE GIVEN TO PREVENT INFECTION. THE WOUND HEALED AND PATIENT WAS DISCHARGED.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 19603677 ↗