ESCALATE 48570300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252464228), received between May 15, 2017 and Feb 6, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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 6, 2018Disassembly; Structural Problem; Disassembly

  IT WAS REPORTED THAT DURING A PROCEDURE, A PLATE WAS OVER EXPANDED AND CAME APART. THE PLATE WAS TAKEN OUT AND REPLACED. THERE WAS A REPORTED DELAY OF 4/5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES.

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

  MAUDE report 7244905 ↗
• MalfunctionMay 15, 2017Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLATE PULLED APART WHEN EXPANDING IT. PULLED PLATE OUT AND NEW PLATE WAS USED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6567967 ↗