OASYS 48560028Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327271393), received between Apr 30, 2018 and Oct 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 1, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT AN OASYS TORQUE WRENCH WAS WORN. THERE WERE NO REPORTED ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562960 ↗
• MalfunctionApr 30, 2018Mechanical Jam; Loose or Intermittent Connection; Mechanical Jam

  IT WAS REPORTED THAT DURING INSTALLATION OF CONNECTOR AND TORQUE WRENCH, CONNECTION WAS LOOSE AND SURGEON WAS NOT ABLE TO PERFORM FINAL TIGHTENING. THE CONNECTOR COULD NOT BE REMOVED FROM THE TORQUE WRENCH. IT IS UNCLEAR HOW MUCH THE DOCTOR COULD TIGHTEN THE SCREW. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7474268 ↗