Inion CompressOn™ Screw 1 (REF OSH-2712)Recalls & reported problems
Inion Oy · 2.7 x 12 mm screw · Class 2 · Implant
Data updated Oct 18, 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 06438408008122), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (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.
Reports received per month
Most reported problems
Device problems
- Crack1
Patient problems
- Loss of fracture reduction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Crack; Crack
TWO INION COMPRESSON SCREWS (2.7*12 MM) WERE USED TO FIX METACARPAL FRACTURES IN A 17-YEAR-OLD PATIENT. THE FOURTH METACARPAL BONE HAD A FRACTURE AT THE DIAPHYSIS, AND IT WAS DIFFICULT TO ALIGN THE ENDS OF THE BONES. WHILE THREADING THE SCREW HOLE, A SMALL PIECE OF BONE BROKE OFF. THIS DID NOT IMPACT THE PLANNED OPERATION AND AFTER THREADING, THE SURGEON STARTED INSERTING ONE INION COMPRESSON SCREW TO THE THREADED SCREW HOLE. HOWEVER, DURING INSERTION, THE SCREW HEAD BROKE WHEN IT HIT THE SURFACE OF THE BONE AND THE SCREW WOULD NO LONGER TURN. THE SCREW WAS LEFT IN PLACE AND ITS HEAD WAS CUT OFF WITH CUTTERS. THE FRACTURE WAS FINALLY REPAIRED WITH CERCLAGE METAL WIRE AND ONE TRANSVERSE K-WIRE. THE SURGERY TOOK APPROXIMATELY 30 MINUTES LONGER, INCLUDING THE INSTALLATION OF THE METAL WIRE AND K-WIRE. THE FRACTURE AT THE DISTAL END OF THE THIRD METACARPAL (MIDDLE FINGER BONE) WAS SUCCESSFULLY FIXED WITH THE INION COMPRESSON SCREW. THE SURGEON WAS SATISFIED WITH THE FIXATION.
Patient problems: Loss of fracture reduction
MAUDE report 23288967 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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