AXSOS 702760Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540693532), received between Jun 20, 2019 and Feb 18, 2020 — classified as 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 18, 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.

• MalfunctionFeb 18, 2020Defective Device; Defective Device

  IT IS REPORTED THAT THE TORQUE LIMITER IS DEFECTIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9721512 ↗
• MalfunctionJun 20, 2019Defective Device

  IT WAS REPORTED THAT THE TORQUE LIMITER DOES NOT WORK PROPERLY. DID NOT HEAR A CLICK SOUND DURING TORQUE, AND TRIED IT SEVERAL TIMES, BUT IT DID NOT WORK PROPERLY. NO SURGICAL DELAY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8716501 ↗