OASYS 48561024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327271300), received between Jun 24, 2016 and Jan 23, 2017 — 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 23, 2017Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING POSTERIOR CERVICAL PROCEDURE THE SCREWDRIVERS STRIPPED OUT AND THE PERSUADER BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6270637 ↗
• MalfunctionJun 24, 2016Break; Disassembly; Mechanical Problem; Disassembly; Mechanical Problem

  IT WAS REPORTED THAT; PERSUADER SCREW BROKE. UPDATE 3-JUN-2016: WE WERE TRYING TO PERSUADE THE ROD INTO THE TULIP HEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5749006 ↗