OASYS 48560022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327271133), received between Jun 30, 2017 and Jan 11, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJan 11, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT A RIGHT INSITU BENDER SNAPPED WHILE BENDING VITALLIUM ROD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181690 ↗
• MalfunctionJun 30, 2017Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; SURGEON WAS USING THE IN SITU BENDERS TO MANIPULATE THE ROD IN PATIENT AND THE TIP BROKE OFF. NO HARM WAS DONE TO THE PATIENT AND EVERYTHING WAS RECOVERED. WHEN GETTING THE INSTRUMENT BACK AFTER THE WASHERS THE TIP HAD GONE MISSING. WAS LOST IN WASHER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6681587 ↗