AXSOS 661070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252579946), received between Jan 18, 2022 and Oct 14, 2022 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THERE WERE 3 SCREWS THAT DID NOT ALLOW LOCKING ON THE PLATE USED, EVEN FOLLOWING THE SURGICAL TECHNIQUE CORRECTLY. THEY DID NOT LOCK WITH THE DYNAMOMETRIC SCREWDRIVER, THE SCREWS CONTINUED TO ROLL REMAINING UNDER THE PLATE THE OTHERS SCREWS THAT WERE PLACED WORKED AND GOT BLOCKED. SURGEON DECIDED TO REMOVE THEM SINCE THEY ARE NOT FULFILLING ANY FUNCTION. THERE WAS AN UNSPECIFIED SURGICAL DELAY RESULTING FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611199 ↗
• MalfunctionJan 18, 2022Break; Material Fragmentation; Break; Material Fragmentation

  AS REPORTED: "4.0 X 70 MM SCREW STRIPPED WHEN TRYING TO BE BACKED OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282530 ↗