AXSOS 661455Recalls & reported problems
Stryker GmbH · Cortex Screw · Class 2 · Implant
All models of AXSOS (184)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252580478), received between Apr 22, 2019 and May 15, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
Device problems
- Fracture2
- Break1
- Difficult to Remove1
Patient problems
- Device Embedded In Tissue or Plaque2
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2020Fracture; Fracture
IT WAS REPORTED, THE DOCTOR WAS USING THE AXSOS 4.0 SCREWS & INSTRUMENTS WITH A DISTAL TIBIA PLATE AND ATTEMPTING TO LAG A FRACTURE THROUGH THE PLATE WITH A 3.5 CORTEX SCREW. UPON TIGHTENING THE SCREW BROKE AT THE JUNCTION BETWEEN THE HEAD AND WHERE THE THREADS BEGIN.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Known Impact Or Consequence To Patient
MAUDE report 10063634 ↗MalfunctionApr 22, 2019Break; Fracture; Difficult to Remove; Fracture
THE SCREW WAS SCREWED IN MANUALLY AFTER PROPER PRE-DRILLING. THE HEAD OF THE SCREW BROKE OFF. THE SCREW REMAINED IN THE PATIENT. THE BROKEN SCREW HEAD HAS BEEN RECOVERED AND IS AVAILABLE FOR EXAMINATION. NO REVISION PLANNED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8537085 ↗
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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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