AXSOS 661448Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252580454), received between Sep 21, 2018 and May 21, 2022 — classified as 2 injuries, 1 malfunction.
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
- Fracture1
- Migration1
Patient problems
- Failure of Implant1
- No Known Impact Or Consequence To Patient1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PROXIMAL LATERAL TIBIA PLATE AND SCREWS WERE BROKEN. DUE TO AN ACUTE INFECTION, THE BROKEN IMPLANTS, A MEDIAL PLATE AND ADDITIONAL SCREWS, WERE REMOVED AND RESOLVED WITH TEMPORARY EXTERNAL FIXATION PLACEMENT.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 14466141 ↗MalfunctionMar 29, 2019Break
IT WAS REPORTED THAT, ON (B)(6) 2019, DR. WAS FIXING A DISTAL TIBIA FRACTURE. DURING THE IMPLANTING OF TWO DIFFERENT SCREWS, THE SCREWS SNAPPED AND BROKE IN HALF. ADDITIONALLY DURING DRILLING, THE TIP OF THE DRILL BIT BROKE IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8464238 ↗InjurySep 21, 2018Migration
THE PATIENT WAS TREATED WITH A AXSOS PHL PLATE ON (B)(6) 2018. THE PATIENT COMPLAINED OF PAIN DURING HER FOLLOW-UP VISIT ON (B)(6) 2018. SCREWS OF THE PLATE HAD EMIGRATED. THE PATIENT HAD TO BE OPERATED AGAIN.
Patient problems: Pain
MAUDE report 7899264 ↗
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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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