Inion FreedomScrew™ 1 (REF OSA-3545)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06438408003301), received between Nov 3, 2023 and Jul 3, 2024 — 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 16, 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.

• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  66-YEAR OLD PATIENT WAS IN A CAR ACCIDENT AND WAS OPERATED DUE TO A TRAUMATIC OPEN ANKLE FRACTURE WITH DISLOCATION AND BONE DEFECT. BOTH INTERNAL AND EXTERNAL FIXATION WERE USED. THE FRACTURE WAS INITIALLY FIXATED WITH A METAL PLATE, METAL BONE PINS, ABSORBABLE SUTURES, ALLOGRAFT BONE, SILICONE DRAINAGE DEVICE AND INION FREEDOMSCREW. IN ADDITION TO ANKLE FRACTURE THE PATIENT ALSO SUFFERED FROM OTHER INJURIES DUE TO THE CAR ACCIDENT INCLUDING RIGHT TALUS FRACTURE, RIGHT ANKLE SKIN CONTUSION AND RIGHT LOWER LIMB VASCULAR INJURIES, AND UNDERWENT RIGHT ANKLE DEBRIDEMENT, PLASTER FIXATION, CLOSED NEGATIVE PRESSURE DRAINAGE (VSD) OF THE WOUND, VASCULAR EXPLORATION AND LOCAL FASCIAL FLAP PLASTY. THE PATIENT WAS DISCHARGED AND LATER THE EXTERNAL FIXATION WAS REMOVED AT A TIME OF OUTPATIENT REVIEW. 4 MONTHS AFTER FIXATION OF THE TRAUMATIC ANKLE FRACTURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER AN OUTPATIENT CHECKUP DUE TO POSTOPERATIVE WOUND INFECTION AND PLATE EXPOSURE IN THE RIGHT ANKLE, AND UNDERWENT ANOTHER SURGICAL PROCEDURE. THE SECOND PROCEDURE WAS RIGHT ANKLE FRACTURE POSTOPERATIVE DEBRIDEMENT OF THE EXPOSED PLATE, REMOVAL OF THE INTERNAL FIXATION, INTERNAL FIXATION OF THE AN

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 19664436 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BIOABSORBABLE INION FREEDOMSCREW (3.5 X 45 MM, REF OSA -3545) WAS USED IN A RIGHT ANKLE FRACTURE OPERATION ON (B)(6), 2023 ON A 29-YEAR OLD MALE PATIENT. THE PATIENT SUFFERED A SPRAIN FROM PLAYING FOOTBALL RESULTING IN A SWOLLEN AND PAINFUL RIGHT ANKLE, AND WENT TO THE HOSPITAL WHERE AN X-RAY EXAMINATION SHOWED AN INTERRUPTION IN THE BONY CONTINUITY OF THE RIGHT ANKLE JOINT. THE RIGHT LATERAL ANKLE WAS FIXED WITH A KINGSTAR LOCKING PLATE (TITANIUM ALLOY), AND THE SEPARATED LOWER TIBIOFIBULAR JOINT WAS FIXED WITH ONE INION FREEDOMSCREW. BASED ON THE INFORMATION RECEIVED BY INION, THE FRACTURE WAS SATISFACTORILY REPOSITIONED WITH A BALANCED JOINT SPACE AND SOLIDLY FIXED ON FLUOROSCOPY DURING THE OPERATION. 10 DAYS AFTER OPERATION ((B)(6), 2023), THE WOUND BECAME INFECTED. A DEBRIDEMENT WAS PERFORMED TO THE WOUND. INION HAS NOT RECEIVED INFORMATION WHETHER BACTERIAL SAMPLES WERE TAKEN FROM THE PATIENT AND IF ANTIBIOTIC TREATMENT WAS GIVEN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 18063123 ↗