EVEREST® Spinal System 2911-07550Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888857042711), received between Apr 16, 2021 and Jul 13, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT 4 EVEREST POLYAXIAL SCREWS FRACTURED INTRA-OPERATIVELY DURING SCREW INSERTION AND REMOVAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. THIS REPORT CAPTURES THE THIRD OF THE FOUR SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004806 ↗
• MalfunctionJul 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT 4 EVEREST POLYAXIAL SCREWS FRACTURED INTRA-OPERATIVELY DURING SCREW INSERTION AND REMOVAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. THIS REPORT CAPTURES THE FOURTH OF THE FOUR SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004794 ↗
• MalfunctionJul 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT 4 EVEREST POLYAXIAL SCREWS FRACTURED INTRA-OPERATIVELY DURING SCREW INSERTION AND REMOVAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. THIS REPORT CAPTURES THE SECOND OF THE FOUR SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004763 ↗
• MalfunctionJul 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT 4 EVEREST POLYAXIAL SCREWS FRACTURED INTRA-OPERATIVELY DURING SCREW INSERTION AND REMOVAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. THIS REPORT CAPTURES THE FIRST OF THE FOUR SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004759 ↗
• MalfunctionMar 3, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT THE TULIP OF AN EVEREST POLYAXIAL SCREW "POPPED OFF" DURING INTRA-OPERATIVE SCREW INSERTION AT S1. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663316 ↗
• InjuryAug 13, 2021Fracture; Fracture

  IT WAS REPORTED THAT THREE EVEREST POLYAXIAL SCREWS FRACTURED DURING SURGERY. TWO SCREWS BROKE UPON INSERTION. THE THIRD SCREW FRACTURED WHEN THE SURGEON ATTEMPTED TO REMOVE AND REPOSITION IT AFTER DECIDING IT WAS TOO LONG. THERE WAS A SURGICAL DELAY OF MORE THAN TWO HOURS AND THE PROCEDURE WAS NOT COMPLETED AS PLANNED. THIS REPORT CAPTURES THE FIRST OF THE THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321584 ↗
• MalfunctionApr 16, 2021Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT ONE EVEREST POLYAXIAL SCREW FRACTURED AND TWO EVEREST POLYAXIAL SCREWS MIGRATED. THE PATIENT WAS UNDERGOING A REVISION SURGERY APPROXIMATELY ONE YEAR AFTER IMPLANTATION TO ADDRESS NON-FUSION WHEN THE SURGEON IDENTIFIED THE FRACTURE AND MIGRATIONS, WHICH THEY ATTRIBUTED TO THE PATIENT'S PSEUDO-ARTHROSIS. THIS REPORT CAPTURES THE FRACTURED SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678269 ↗