AXSOS 661028Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252579793), received between Sep 21, 2018 and Sep 30, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device2
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2020Defective Device; Defective Device
THE FOLLOWING EVENT WAS REPORTED THAT: "WE HAVE JUST RECEIVED A MATERIALOVIGILANCE CONCERNING THE AXSOS CORTICAL SCREWS. ON THE RADIO, THE SCREWS WERE BENT, AND THE THREADS WERE TURNING SCREWS CONCERNED: 2 SCREWS BENT DURING PLACEMENT: 1 CORTICAL 3.5 IN 32MM AND 1 CORTICAL 3.5 IN 40MM: AND 2 SCREWS WITH BAD THREAD: 2 CORTICAL 3.5 IN 40MM AND 2 LOCKED SCREWS IN 28MM CONSEQUENCES: THE SURGEON REMOVED THE SCREWS AND PUT IN NEW ONES.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10609874 ↗MalfunctionSep 30, 2020Defective Device; Defective Device
THE FOLLOWING EVENT WAS REPORTED THAT: "WE HAVE JUST RECEIVED A MATERIALOVIGILANCE CONCERNING THE AXSOS CORTICAL SCREWS. ON THE RADIO, THE SCREWS WERE BENT, AND THE THREADS WERE TURNING. SCREWS CONCERNED: 2 SCREWS BENT DURING PLACEMENT: 1 CORTICAL 3.5 IN 32MM AND 1 CORTICAL 3.5 IN 40MM: AND 2 SCREWS WITH BAD THREAD: 2 CORTICAL 3.5 IN 40MM AND 2 LOCKED SCREWS IN 28MM. CONSEQUENCES: THE SURGEON REMOVED THE SCREWS AND PUT IN NEW ONES.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10609871 ↗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 7899326 ↗
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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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