EVEREST Spinal System 5101-90195Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10888857290679), received between Oct 19, 2020 and Nov 13, 2020 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Fracture” (46 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 4, 2020Class IITerminated

   All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks

   Z-0542-2021 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2020Fracture; Fracture

  A PHYSICIAN REPORTED THAT AN EVEREST XT TAB REMOVAL TOOL HANDLE FRACTURED INTRAOPERATIVELY. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10838727 ↗
• MalfunctionOct 21, 2020Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED FOUR FRACTURED EVEREST XT TAB REMOVAL TOOLS. THE HANDLES WERE FOUND TO BE FRACTURED DURING PRODUCT INSPECTION; THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT CAPTURES THE FOURTH OF FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10714901 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED TWO FRACTURED EVEREST XT TAB REMOVAL TOOLS. THE HANDLES WERE FOUND TO BE FRACTURED DURING PRODUCT INSPECTION; THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT CAPTURES THE SECOND OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708375 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT AN EVEREST XT TAB REMOVAL TOOL WAS RECEIVED DAMAGED PRE-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT AND NO ASSOCIATED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708374 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  PHYSICIAN REPORTED THAT THE HANDLE OF AN EVEREST XT TAB REMOVAL TOOL WAS OBSERVED TO BE FRACTURED DURING INSPECTION. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708373 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED TWO FRACTURED EVEREST XT TAB REMOVAL TOOLS. THE HANDLES WERE FOUND TO BE FRACTURED DURING PRODUCT INSPECTION; THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT CAPTURES THE FIRST OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708372 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED A FRACTURED EVEREST XT TAB REMOVAL TOOL. THE HANDLE WAS FOUND TO BE FRACTURED DURING PRODUCT INSPECTION; THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708369 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE HANDLE OF AN EVEREST XT TAB REMOVAL TOOL FRACTURED AND RED LIQUID LEAKED OUT FROM IT AFTER STERILIZATION. THE CUSTOMER REPORTED THE FRACTURE OCCURRED BEFORE THE STERILIZATION PROCESS DURING THE PRIOR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708366 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED A FRACTURED EVEREST XT TAB REMOVAL TOOL. THE HANDLE WAS FOUND TO BE FRACTURED DURING PRODUCT INSPECTION; THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708170 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A PHYSICIAN REPORTED THAT TWO EVEREST XT TAB REMOVAL TOOL HANDLES FRACTURED DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 20-MINUTE SURGICAL DELAY NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708160 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A PHYSICIAN REPORTED THAT AN EVEREST XT TAB REMOVAL TOOL HANDLE FRACTURED DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 20-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708159 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT AN EVEREST XT TAB REMOVAL TOOL HANDLE FRACTURED INTRA-OPERATIVELY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708047 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A PHYSICIAN REPORTED THAT AN EVEREST XT TAB REMOVAL TOOL HANDLE FRACTURED DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708046 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT AN EVEREST XT TAB REMOVAL TOOL HANDLE FRACTURED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708045 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT AN EVEREST XT TAB REMOVAL TOOL FRACTURED AT THE HANDLE OUTSIDE OF THE OPERATING THEATRE. THERE WAS NO ASSOCIATED SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO A PATIENT OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708042 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE HANDLE OF AN EVEREST XT TAB REMOVAL TOOL FRACTURED AND RED LIQUID LEAKED OUT FROM IT AFTER STERILIZATION. THE CUSTOMER REPORTED THE FRACTURE OCCURRED BEFORE THE STERILIZATION PROCESS DURING THE PRIOR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708039 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A PHYSICIAN REPORTED THAT AN EVEREST XT TAB REMOVAL TOOL HANDLE FRACTURED DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY OR ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708037 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE HANDLE OF AN EVEREST XT TAB REMOVAL TOOL FRACTURED AND RED LIQUID LEAKED OUT FROM IT AFTER STERILIZATION. THE CUSTOMER REPORTED THE FRACTURE OCCURRED BEFORE THE STERILIZATION PROCESS DURING THE PRIOR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708035 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A PHYSICIAN REPORTED THAT TWO EVEREST XT TAB REMOVAL TOOLS FRACTURED AT THE HANDLE INTRAOPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10707893 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED FOUR FRACTURED EVEREST XT TAB REMOVAL TOOLS. THE HANDLES WERE FOUND TO BE FRACTURED DURING PRODUCT INSPECTION; THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT CAPTURES THE THIRD OF FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10707891 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED FOUR FRACTURED EVEREST XT TAB REMOVAL TOOLS. THE HANDLES WERE FOUND TO BE FRACTURED DURING PRODUCT INSPECTION; THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT CAPTURES THE SECOND OF FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10707889 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A PHYSICIAN REPORTED THAT AN EVEREST XT TAB REMOVAL TOOL HANDLE FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY COMPLETED WITH A BACK-UP INSTRUMENT AND A SURGICAL DELAY OF APPROXIMATELY 20 MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10707886 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED TWO FRACTURED EVEREST XT TAB REMOVAL TOOLS. THE HANDLES WERE FOUND TO BE FRACTURED DURING PRODUCT INSPECTION; THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT CAPTURES THE FIRST OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10707885 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED TWO FRACTURED EVEREST XT TAB REMOVAL TOOLS. THE HANDLES WERE FOUND TO BE FRACTURED DURING PRODUCT INSPECTION; THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT CAPTURES THE SECOND OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10707883 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED FOUR FRACTURED EVEREST XT TAB REMOVAL TOOLS. THE HANDLES WERE FOUND TO BE FRACTURED DURING PRODUCT INSPECTION; THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT CAPTURES THE FIRST OF FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10707882 ↗