EVEREST Spinal System 2901-90098Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10888857040564), received between May 20, 2020 and Jan 30, 2023 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2023Corroded; Material Deformation; Corroded; Material Deformation

  THIS RECORD IS A CONSOLIDATION OF Q4 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES SEVEN INSTANCES OF INTRAOPERATIVE EVEREST LOCKING SCREW INSERTER DEFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264993 ↗
• MalfunctionOct 28, 2022Fracture; Material Deformation; Fracture; Material Deformation

  THIS RECORD IS A CONSOLIDATION OF Q3 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES THREE INSTANCES OF INTRAOPERATIVE EVEREST LOCKING SCREW INSERTER DEFORMATION. THE ASSOCIATED PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694260 ↗
• MalfunctionJul 29, 2022Material Deformation; Material Deformation

  THIS REPORT CAPTURES FOUR INSTANCES OF INTRAOPERATIVE EVEREST LOCKING SCREW INSERTER TIP DEFORMATION. IN ALL CASES, THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO A PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131915 ↗
• MalfunctionApr 29, 2022Material Deformation; Material Deformation

  THIS RECORD IS A CONSOLIDATION OF Q1 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE EVEREST LOCKING SCREW INSERTER TIP DEFORMATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254547 ↗
• MalfunctionJan 27, 2022Material Deformation; Material Deformation

  THIS RECORD IS A CONSOLIDATION OF Q4 2021 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES EIGHT INSTANCES OF INTRAOPERATIVE EVEREST LOCKING SCREW INSERTER TIP DEFORMATION. IN ALL CASES, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. THERE WAS NO SURGICAL DELAY IN SEVEN OF THE EVENTS; ONE EVENT INVOLVED AN UNSPECIFIED DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13369552 ↗
• MalfunctionOct 29, 2021Fracture; Material Deformation; Fracture; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE THE TIP OF EVEREST LOCKING SCREW INSERTER "STRIPPED" INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER DRIVER AND NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12723442 ↗
• MalfunctionJul 30, 2021Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES EIGHT MALFUNCTION EVENTS IN WHICH EVEREST LOCKING SCREW INSERTERS WERE NOTED TO HAVE TIP DEFORMATIONS INTRA-OPERATIVELY. SURGERIES WERE SUCCESSFULLY COMPLETED WITH ADDITIONAL INSERTERS AND NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12254995 ↗
• MalfunctionApr 30, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THIS REPORT SUMMARIZES TWELVE MALFUNCTION EVENTS WHERE THE TIPS OF EVEREST LOCKING SCREW INSERTERS "STRIPPED" INTRA-OPERATIVELY. SURGERIES WERE SUCCESSFULLY COMPLETED WITH ANOTHER DRIVER. ONE PROCEDURE EXPERIENCED A FIVE MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753447 ↗
• MalfunctionJan 29, 2021Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES NINE MALFUNCTION EVENTS WHERE THE TIP OF EVEREST LOCKING SCREW INSERTERS DEFORMED INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED AND ONE EVENT EXPERIENCED A 20 TO 30 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11254336 ↗
• MalfunctionOct 16, 2020Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT AN EVEREST LOCKING SCREW INSERTER TIP DEFORMED INTRA-OPERATIVELY. THE TIP WOULD NO LONGER FIT INTO THE INTERFACE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT SURGICAL DELAY, BY USING ANOTHER INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10688284 ↗
• MalfunctionSep 30, 2020Deformation Due to Compressive Stress; Mechanical Jam; Deformation Due to Compressive Stress; Mechanical Jam

  IT WAS REPORTED THAT TWO EVEREST LOCKING SCREW INSERTER TIPS JAMMED INTRA-OPERATIVELY. THE DRIVERS CROSS THREADED WITH SCREW AND TAMPERED THE THREADS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT REPRESENTS THE SECOND OF THE TWO INSERTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10607326 ↗
• MalfunctionSep 30, 2020Deformation Due to Compressive Stress; Mechanical Jam; Deformation Due to Compressive Stress; Mechanical Jam

  IT WAS REPORTED THAT TWO EVEREST LOCKING SCREW INSERTER TIPS JAMMED INTRA-OPERATIVELY. THE DRIVERS CROSS THREADED WITH SCREW AND TAMPERED THE THREADS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT REPRESENTS THE FIRST OF THE TWO INSERTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10607324 ↗
• MalfunctionSep 8, 2020Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT THE TIP OF AN EVEREST LOCKING SCREW INSERTER STRIPPED INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH A SECOND DRIVER AND NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10505379 ↗
• MalfunctionSep 8, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN EVEREST LOCKING SCREW INSERTER BECAME DEFORMED DURING INTRA-OPERATIVE IMPLANT INSERTION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10502589 ↗
• MalfunctionSep 4, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT UPON ATTEMPTED SCREW INSERTION, THE TIPS OF TWO EVEREST LOCKING SCREW INSERTERS 'STRIPPED'. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVELY AVAILABLE INSTRUMENT. THIS RECORD REPRESENTS THE SECOND OF THE TWO LOCKING SCREW INSERTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10497213 ↗
• MalfunctionSep 4, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT UPON ATTEMPTED SCREW INSERTION, THE TIPS OF TWO EVEREST LOCKING SCREW INSERTERS 'STRIPPED'. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVELY AVAILABLE INSTRUMENT. THIS RECORD REPRESENTS THE FIRST OF THE TWO LOCKING SCREW INSERTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10497210 ↗
• MalfunctionAug 28, 2020Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  A PHYSICIAN REPORTED THAT TWO EVEREST LOCKING SCREW INSERTERS WERE 'STRIPPED' INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT REPRESENTS THE FIRST OF THE TWO INSERTERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10467419 ↗
• MalfunctionAug 28, 2020Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  A PHYSICIAN REPORTED THAT TWO EVEREST LOCKING SCREW INSERTERS WERE 'STRIPPED' INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS RECORD REPRESENTS THE SECOND OF THE TWO INSERTERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10467411 ↗
• MalfunctionJul 31, 2020Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT WHERE AN EVEREST SPINAL SYSTEM LOCKING SCREW INSERTER JAMMED INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 15-20 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10350530 ↗
• MalfunctionJul 28, 2020Material Twisted/Bent; No Apparent Adverse Event; Material Twisted/Bent; No Apparent Adverse Event

  IT WAS REPORTED THAT TWO EVEREST LOCKING SCREW INSERTER TIPS WERE DAMAGED INTRA-OPERATIVELY. THE INSTRUMENTS REPEATEDLY BECAME UNLOCKED AND LOOSENED DURING INSERTION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT REPRESENTS THE SECOND OF THE TWO INSERTERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10336023 ↗
• MalfunctionJul 28, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT TWO EVEREST LOCKING SCREW INSERTER TIPS WERE DAMAGED INTRA-OPERATIVELY. THE INSTRUMENTS REPEATEDLY BECAME UNLOCKED AND LOOSENED DURING INSERTION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT REPRESENTS THE FIRST OF THE TWO INSERTERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10335927 ↗
• InjuryMay 20, 2020Difficult to Insert; Deformation Due to Compressive Stress; Difficult to Insert; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT AN EVEREST LOCKING SCREW INSERTER JAMMED AND AN EVEREST POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY. WHEN THE SURGEON ATTEMPTED TO REMOVE THE SCREW, THE SCREW HEAD POPPED OFF AND WAS STUCK ON THE INSTRUMENT. THERE WAS NO SURGICAL DELAY, HOWEVER THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AS THE ROD WAS NOT ABLE TO BE CONNECTED AT THE DESIRED LEVEL AND THE SCREW SHAFT REMAINED IN THE PATIENT. THIS REPORT REPRESENTS THE SCREW INSERTER.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 10075639 ↗