AXSOS 661428Recalls & 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 07613252580355), received between Oct 24, 2018 and May 18, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Fracture1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
- Foreign Body In Patient1
- Implant Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2023Break; Fracture; Break; Fracture
AS REPORTED: PT BROKE THEIR RIGHT HUMERUS AND WAS COMPLIANT TO ALL MOBILITY INSTRUCTIONS. PATIENT WENT TO BED AND WOKE UP THE FOLLOWING MORNING AND EXPERIENCED PAIN IN THEIR ARM AND KNEW THAT SOMETHING WAS WRONG. WENT INTO THE HOSPITAL, X-RAYS WERE TAKEN AND IT WAS CONFIRMED THAT THE SCREW HEADS WERE BROKEN WITHIN 3-4 WEEKS POST OP. THE HEADLESS SCREWS WERE LEFT IN BUT THE PLATE AND REMAINING SCREWS WERE REMOVED. PATIENT WAS REVISED AND IS HAVING NO ISSUES WITH THE PLATE.
Patient problems: Failure of Implant; Foreign Body In Patient; Implant Pain
MAUDE report 16953264 ↗InjuryOct 24, 2018Appropriate Device Problem Term/Code Not Available
THE HOSPITAL REPORTED THE FOLLOWING EVENT : "DURING RADIOGRAPHIC INSPECTION AT 9 MONTHS OF OSTEOSYNTHESIS SHOWS A PSEUDOSEPTIC OSTEOARTHRITIS OF THE LEFT TIBIA WITH FRACTURE OF THE OSTEOSYNTHESIS PLATE (PLACED ON (B)(6) 2018 FOLLOWING AN OPEN FRACTURE IN THE LEFT LEG). PROVISIONAL MEASURES AND ACTIONS TAKEN: NEED FOR SURGICAL RESUMPTION ON (B)(6) 2018 WITH REMOVAL OF THE MATERIAL, SAMPLES, FIRST TIME MASK WITH SPACER IN CEMENT FIXATION BY EXTERNAL FIXATOR AND ANTIBIOTIC THERAPY. THE DEVICE HAS BEEN RETAINED FOR EXPERTISE. CLINICAL CONSEQUENCES NOTED: NEED FOR SURGICAL RESUMPTION AND SEPTIC PSEUDARTHROSIS."
Patient problems: Bone Fracture(s)
MAUDE report 8002694 ↗
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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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