AXSOS 371536Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154864263), received between Aug 5, 2019 and Oct 3, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Break; Fracture; Material Deformation; Positioning Problem; Break; Fracture; Material Deformation; Positioning Problem

  IT WAS REPORTED, THE THREADS ON THE TWO LOCKING GUIDES, REFERENCE (B)(4) , ARE IN POOR CONDITION. THIS ISSUE CAUSES INCORRECT SCREW ALIGNMENT BECAUSE THE SYSTEM IS UNIAXIAL AND ALTERS THE DIRECTION OF THE LOCKING SCREW. AS A RESULT, WHEN ATTEMPTING TO INSERT A 4.0X36MM LOCKING SCREW, REFERENCE (B)(4) , THE FORCE AND THE CHANGE IN THE ALIGNMENT OF THE LOCKING GUIDE CAUSED THE SCREW HEAD TO BREAK OFF, LEAVING IT INSIDE THE PATIENT. A SURGICAL DELAY OF 15-20 MINUTES WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20362947 ↗
• MalfunctionAug 5, 2019Fracture; Difficult to Remove

  AS REPORTED: "THE HEAD OF THE SCREW WAS SPLIT WHEN TRYING TO PUT IT TO THE END, IT WAS HAPPENING MANUALLY, IN THE SAME DIRECTION AS THE GUIDE. THE SCREW IS BLOCKED DURING THE SAME PROCEDURE, ONE OF THE SCREWS DID NOT PASS PROPERLY THROUGH THE PLATE, WAS CHANGED BY ANOTHER AND THIS DID NOT ENTER IN ITS TOTALIDADE." ADDITIONALLY: "REMAINS A SCREW WITHOUT HEAD INSIDE THE PATIENT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ADVERSE CONSEQUENCES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8862856 ↗