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AXSOS 661055Recalls & reported problems

Stryker GmbH · Locking Screw · Class 2 · Implant

All models of AXSOS (184)

Data updated Oct 18, 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 07613252579915), received between Jun 15, 2018 and Jun 15, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 18, 2026.

Most reported problems

Device problems

  • Device Operates Differently Than Expected1

Patient problems

  • 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.

  • MalfunctionJun 15, 2018Device Operates Differently Than Expected

    THE CUSTOMER REPORTED THAT DURING IMPLANTATION OF AN AXSOS 3 TIBIAL PLATE THE SURGEON NOTICED SWARF BUILDING UP AROUND THE HEAD OF THE AXSOS 3 LOCKING SCREW AS HE WAS INSERTING IT BY HAND.ON THE X-RAY THE SURGEON COULD SEE THAT DEBRIS HAD BUILT UP AT THE PLATE HOLE AND THE THREAD WAS NO LONGER ON THE SCREW. ANOTHER SCREW WAS USED TO COMPLETE THE CASE. ALL SWARF WAS REMOVED FROM THE PATIENT. THERE WERE NO DELAYS TO THE CASE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7606777 ↗

Other Plate, fixation, bone devices

All Plate, fixation, bone devices →

Sources and updates

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