AXSOS 661446SRecalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540686459), received between Nov 4, 2022 and Nov 11, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break2
- Fracture2
Patient problems
- Failure of Implant2
- Nonunion/Delayed-union Bone Fracture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2022Break; Fracture; Break; Fracture
THE CUSTOMER REPORTED THAT: "A PATIENT OPERATED ON FOR AN ANTERIOR SHOULDER BLOCK, COMES BACK TO THE TO THE CLINIC AFTER SEVERAL DAYS, THE PRACTITIONER NOTICES THAT ONE OF THE SCREWS PUT IN PLACE HAS BROKEN, AND IT IS CLEAR THAT THE THAT THE GRAFT IS NO LONGER MAINTAINED. UNMAINTAINED GRAFT REQUIRING A SURGICAL REVISION, WITH CHANGE OF SCREW AND GRAFT." ADDITIONAL INFORMATION RECEIVED: NON-UNION, BUT EARLY SCREW BREAKAGE. BOTH SCREWS ARE BROKEN.
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 15779667 ↗InjuryNov 4, 2022Break; Fracture; Break; Fracture
THE CUSTOMER REPORTED THAT: "A PATIENT OPERATED ON FOR AN ANTERIOR SHOULDER BLOCK, COMES BACK TO THE TO THE CLINIC AFTER SEVERAL DAYS, THE PRACTITIONER NOTICES THAT ONE OF THE SCREWS PUT IN PLACE HAS BROKEN, AND IT IS CLEAR THAT THE THAT THE GRAFT IS NO LONGER MAINTAINED. UNMAINTAINED GRAFT REQUIRING A SURGICAL REVISION, WITH CHANGE OF SCREW AND GRAFT." ADDITIONAL INFORMATION RECEIVED: NON-UNION, BUT EARLY SCREW BREAKAGE. BOTH SCREWS ARE BROKEN.
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 15735241 ↗
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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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