OASYS 48565323Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327271874), received between Feb 16, 2018 and Feb 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2018Dull, Blunt; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I WAS REPORTED THAT; DURING SURGERY, A LATERAL MASS SCREW HOLE AT C6 WAS ATTEMPTED TO BE CREATED USING AN ADJUSTABLE DRILL GUIDE AND DRILL. THE SCREW HOLE BECAME BIGGER THAN EXPECTED BECAUSE THE DRILL FELT BLUNT AND IT WAS NEEDED TO APPLY FORCE. THE SURGERY WAS COMPLETED WITH A RECOVERY SHOT. THE RECOVERY SHOT WAS APPROACHED FROM THE SAME ENTRY POINT TOWARDS THE CORTICAL BONE OF THE C6 / 7 ARTICULAR SURFACE, AND A SCREW WAS IMPLANTED. THERE WAS A REPORTED 30 MINUTE SURGICAL DELAY. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7277227 ↗