AXSOS 661038Recalls & 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 07613252579847), received between Sep 21, 2018 and Sep 21, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2020Positioning Failure; Positioning Failure
AS REPORTED: "THE SCREWS HAD NO HOLD IN THE PLATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10564225 ↗InjurySep 21, 2018Migration or Expulsion of Device
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 7899276 ↗
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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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