AXSOS 661432SRecalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540686381), received between Aug 28, 2020 and Aug 28, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2020Fracture; Fracture
THE CUSTOMER REPORTED THAT A 3.5MM AXSOS CORTICAL SCREW BROKE DURING INSERTION. ADDITIONALLY REPORTED: "NO SCREW PART FELL INTO THE PATIENT, THE HEAD OF THE SCREW BROKE OFF AS IT WAS BEING ADVANCED AND WAS STILL ATTACHED TO THE SCREWDRIVER. IT WAS SUCCESSFULLY REMOVED. I COULD NOT SEE THE ANGLE OR THE PRESSURE SINCE HE WAS OVER THE FRACTURE, HE SAID HE WAS JUST ADVANCING IT NORMALLY. THERE WAS A SLIGHT DELAY BECAUSE HE HAD TO REMOVE THE SCREW FROM THE PATIENT WHICH TOOK ABOUT 5 MINS. SINCE IT WAS NOT FULLY ADVANCED IN THE PATIENT HE WAS ABLE TO TWIST AND PULL THE SHAFT OF THE SCREW OUT WITH PLIERS."
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10467325 ↗
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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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