AXSOS 661030SRecalls & reported problems
Stryker GmbH · Locking 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540685872), received between Apr 17, 2017 and May 11, 2020 — classified as 1 injury, 1 malfunction.
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
- Break1
- Loose or Intermittent Connection1
- Positioning Failure1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2020Positioning Failure; Positioning Failure
AS REPORTED: "AXOS PROXIMAL TIBIA PROCEDURE. THE LOCKING OF THE PLATE AND SCREW WAS BAD. THIS EVENT PROBABLY OCCURRED BECAUSE THE SCREW DID NOT GO STRAIGHT INTO THE OPENED HOLE. THERE MAY ALSO BE A PROBLEM WITH THE BONE QUALITY OF THE PATIENT."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10042307 ↗InjuryApr 17, 2017Break; Loose or Intermittent Connection
ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY WITH THE AXSOS PROXIMAL TIBIA LATERAL PLATE. ON (B)(6) 2016, THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE SCREW INSERTED IN THE BONE ARE BROKEN AND LOOSENING. THEREFORE THE SURGEON DID THE REVISION SURGERY ON(B)(6) 2016.
Patient problems: No Code Available
MAUDE report 6498956 ↗
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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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