EVEREST Spinal System 5101-90160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857279391), received between Feb 3, 2021 and Nov 22, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT OUTSIDE THE OR AN EVEREST XT ROD REDUCER CAME APART AT THE TIP. THERE WAS NO ASSOCIATED PROCEDURE WITH THIS EVENT, THEREFORE, NO ADVERSE CONSEQUENCES TO ANY PATIENTS WERE SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858064 ↗
• MalfunctionFeb 3, 2021Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT TWO EVEREST XT MI ROD REDUCER TOWER TIPS BROKE OFF INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT REPRESENTS THE FIRST OF THE TWO EVEREST XT MI ROD REDUCER TOWER TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276409 ↗
• MalfunctionFeb 3, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO EVEREST XT MI ROD REDUCER TOWER TIPS BROKE OFF INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT REPRESENTS THE SECOND OF THE TWO EVEREST XT MI ROD REDUCER TOWER TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276375 ↗