Inion CompressOn™ Screw 1 (REF OSH-3534)Recalls & reported problems
Inion Oy · 3.5 x 34 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 06438408008412), received between Aug 14, 2024 and Aug 14, 2024 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2024Crack; Crack
DURING MINI-INVASIVE PATELLAR FRACTURE FIXATION, THE SURGEON EXPERIENCED SOME PROBLEMS IN THE INSERTION OF THE INION COMPRESSION SCREW (INION COMPRESSION SCREW 3.5 X 34 MM, HEADLESS, CANNULATED). FINALLY THE SCREW HEAD CRACKED WHILE LOCKING THE SCREW WITH A LITTLE FORCE. HOWEVER, THE FIXATION HAD BEEN COMPLETED AND THE SCREW WAS LEFT IN PLACE. TO ENSURE PROPER PLACEMENT OF THE SCREW, THE SURGEON HAD TO MAKE ANOTHER WOUND TO THE SKIN ON THE OTHER SIDE OF THE BONE TO DETERMINE IF THE SCREW HAD PENETRATED THE BONE ON THE OTHER SIDE. NO ADDITIONAL MEASURES WERE TAKEN AND NO RE-OPERATION WAS NEEDED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 19983174 ↗
Other Screw, fixation, bone devices
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- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- 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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