AXSOS 661434Recalls & 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 07613252580386), received between Mar 17, 2020 and Jul 11, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
- Failure of Implant1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED: DURING THE SURGICAL PROCEDURE, A 3.5 CORTICAL SCREW IS BROKEN INSIDE THE PATIENT. IT IS CURRENTLY UNKNOWN IF PART OF THE BROKEN SCREW REMAINS IN THE PATIENT, AND IF ATTEMPTS WERE MADE TO RETRIEVE IT.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 19719393 ↗MalfunctionMar 17, 2020Fracture; Fracture
CUSTOMER REPORTED THAT : "WHILE THE DOCTOR WAS INSERTING AN AXOS ANCILLARY INSTRUMENT SET PLATE, ONE OF THE CORTEX SCREWS (PART NUMBER: 661434) BROKE. THE BODY OF THE SCREW REMAINED IN THE PATIENT WHILE THE HEAD DETACHED. THE PATIENT IS FINE, THE BODY OF THE SCREW WILL BE REMOVED ALONG WITH THE PLATE."
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9844980 ↗
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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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