Inion CompressOn™ Screw 1 (REF OSH-4545)Recalls & reported problems
Inion Oy · 4.5 x 45 mm screw · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06438408008689), received between Jul 2, 2025 and Jul 2, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure to Osseointegrate1
- Osseointegration Problem1
- Patient-Device Incompatibility1
Patient problems
- Impaired Healing1
- Inflammation1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2025Failure to Osseointegrate; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Failure to Osseointegrate; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem
DUE TO TALONAVICULAR, CALCANEOCUBOIDAL AND SUBTALAR ARTHROSIS (PES PLANOVALGUS), ARTHRODESIS OPERATIONS WERE CONDUCTED FOR THE 59-YEAR-OLD FEMALE PATIENT WITH 5 INION COMPRESSION SCREWS (LISTED BELOW) APPROXIMATELY 2 YEARS AGO. OSH-4545 (LOT: 2109040), 1 SCREW, OSH-4550 (LOT: 2109041), 1 SCREW (REPORTED SEPARATELY), OSH-4526 (LOT: 2109033), 1 SCREW (REPORTED SEPARATELY), OSH-6070 (LOT: 2109046), 2 SCREWS (REPORTED SEPARATELY). DURING OPERATION 3 ARTHRODESIS LINES WERE FIXATED FOR FUSION. NO PROBLEMS DURING OPERATION. CAST WAS APPLIED FOR 8 WEEKS POSTOPERATIVELY. NO AES WERE DETECTED AT 6-WEEK OR 3-MONTH POSTOPERATIVE FOLLOW-UP. HOWEVER, AT 2 YEARS POST-OP, PATIENT REPORTS OF PAIN AND SWELLING SENSATION IN THE OPERATED FOOT. PSEUDOARTHROSIS OF 2/3 BONE LINES IS IDENTIFIED BASED ON X-RAY. BASED ON THE FINDING IN X-RAY AND SYMPTOMS EXPERIENCED BY THE PATIENT, A RE-OPERATION WAS SCHEDULED TO BE COMPLETED WITHIN 6 MONTHS WITH METAL IMPLANTS (THE REOPERATION HAS NOT BEEN CONDUCTED YET).
Patient problems: Impaired Healing; Inflammation; Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 22382024 ↗
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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