AXSOS 661440Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252580416), received between Dec 2, 2019 and Sep 30, 2020 — classified as 3 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

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 MATERIAL OVIGILANCE 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 10609916 ↗
• 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 10609887 ↗
• MalfunctionDec 2, 2019Break; Material Twisted/Bent; Device Handling Problem; Break; Material Twisted/Bent; Device Handling Problem

  PRIMARY LEFT TIBIA PROCEDURE. IT WAS REPORTED THAT THE 3.5 CORTICAL SCREW WAS BEING INSERTED OUTSIDE OF THE 20° CONE OF ANGULATION IN THE SHAFT AND WAS VISIBLY BENDING DURING INSERTION. IT IS NOT KNOWN IF THE SCREW WAS ALIGNED WITH THE DRILL HOLE IN THE FAR CORTEX. THE SCREW BROKE INSIDE THE PATIENT. AS THE HEAD WAS ENGAGED WITH THE PLATE AND WAS NOT SITTING PROUD, THE SURGEON MADE THE DECISION TO LEAVE THE ENTIRETY OF THE SCREW IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE REP MAY BE ABLE TO OBTAIN X-RAYS, AND OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9394774 ↗