EVEREST Spinal System 5101-90129Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10888857210141), received between Mar 18, 2020 and Jan 30, 2023 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (15 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2023Mechanical Jam; Mechanical Jam

  THIS RECORD IS A CONSOLIDATION OF Q4 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES THREE INSTANCE OF INTRAOPERATIVE EVEREST MI PROVISIONAL SPLIT DRIVER JAMMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16265122 ↗
• MalfunctionOct 29, 2022Mechanical Jam; Mechanical Jam

  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 INSTANCE OF INTRAOPERATIVE EVEREST MI PROVISIONAL SPLIT DRIVER JAMMING. 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 15696269 ↗
• MalfunctionAug 1, 2022Failure to Eject; Failure to Eject

  THIS RECORD IS A CONSOLIDATION OF Q2 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES SEVEN INSTANCES OF INTRAOPERATIVE EVEREST PROVISIONAL SPLIT DRIVER JAMMING. IN ONE (OF SEVEN) INSTANCES, THE REPORTED EVENT WAS NOTED DURING STERILIZATION; THERE WAS NO PROCEDURE ASSOCIATED WITH THE EVENT AND NO PATIENT INVOLVEMENT. IN FOUR (OF SEVEN) INSTANCES, THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO A PATIENT OR USER. IN TWO (OF SEVEN) INSTANCES, 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 15138157 ↗
• MalfunctionJan 31, 2022Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS WHERE THE KNOBS OF EVEREST MI PROVISIONAL SPLIT DRIVERS JAMMED INTRA-OPERATIVELY. SURGERIES WERE SUCCESSFULLY COMPLETED WITH NO DELAY AND ANOTHER DRIVER. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13404708 ↗
• MalfunctionOct 29, 2021Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE THE HANDLE OF AN EVEREST MI PROVISIONAL SPLIT DRIVER "JAMMED" 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 12723555 ↗
• MalfunctionAug 3, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AN EVEREST MI PROVISIONAL SPLIT DRIVER WAS "FOUND BROKEN IN TRAY" INTRA-OPERATIVELY. UPON REVIEW OF THE RETURNED DEVICE, IT HAS BEEN DETERMINED THAT THE DRIVER KNOB HAD JAMMED. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268977 ↗
• MalfunctionJul 29, 2021Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS IN WHICH EVEREST MI PROVISIONAL SPLIT DRIVERS JAMMED INTRA-OPERATIVELY. TWO DEVICES, "LOCKED INTO DRIVER AND WILL NOT ROTATE," ONE DEVICE, "WAS NOT RETAINING THE SET SCREW," DUE TO A JAMMED KNOB. SURGERIES WERE SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249401 ↗
• MalfunctionApr 29, 2021Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES FIVE MALFUNCTION EVENTS WHERE AN EVEREST MI PROVISIONAL SPLIT DRIVER 'LOCKED UP' INTRA-OPERATIVELY. SURGERIES WERE 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 11746454 ↗
• MalfunctionJan 29, 2021Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 10 MALFUNCTION EVENTS WHERE EVEREST MI PROVISIONAL SPLIT DRIVERS JAMMED AND WOULD NOT RETAIN SCREWS INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11252544 ↗
• MalfunctionAug 13, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AN EVEREST MI PROVISIONAL SPLIT DRIVER JAMMED INTRA-OPERATIVELY. THE KNOB OF THE DRIVER WOULD NOT TURN AND THE TIP WOULD NOT ATTACH TO SET SCREWS. 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; No Consequences Or Impact To Patient

  MAUDE report 10402584 ↗
• MalfunctionAug 6, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AN EVEREST MI PROVISIONAL SPLIT DRIVER JAMMED INTRA-OPERATIVELY. THE DRIVER GOT STUCK AND WAS UNABLE TO TIGHTEN OR LOOSEN THE SET SCREW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY BY USING A BACKUP DRIVER.

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

  MAUDE report 10375151 ↗
• MalfunctionJul 28, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THREE EVEREST MI PROVISIONAL SPLIT DRIVERS JAMMED INTRA-OPERATIVELY. THE DRIVERS WERE NOT ABLE TO ATTACH TO THE SET SCREW AND THE KNOBS WOULD NOT TURN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT SURGICAL DELAY, BY USING AN ALTERNATE INSTRUMENT. THIS REPORT REPRESENTS THE THIRD OF THE THREE DRIVERS.

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

  MAUDE report 10335660 ↗
• MalfunctionJul 28, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THREE EVEREST MI PROVISIONAL SPLIT DRIVERS JAMMED INTRA-OPERATIVELY. THE DRIVERS WERE NOT ABLE TO ATTACH TO THE SET SCREW AND THE KNOBS WOULD NOT TURN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT SURGICAL DELAY, BY USING AN ALTERNATE INSTRUMENT. THIS REPORT REPRESENTS THE FIRST OF THE THREE DRIVERS.

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

  MAUDE report 10335657 ↗
• MalfunctionJul 28, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THREE EVEREST MI PROVISIONAL SPLIT DRIVERS JAMMED INTRA-OPERATIVELY. THE DRIVERS WERE NOT ABLE TO ATTACH TO THE SET SCREW AND THE KNOBS WOULD NOT TURN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT SURGICAL DELAY, BY USING AN ALTERNATE INSTRUMENT. THIS REPORT REPRESENTS THE SECOND OF THE THREE DRIVERS.

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

  MAUDE report 10335588 ↗
• InjuryMar 18, 2020Mechanical Jam; Mechanical Jam

  STRYKER REPRESENTATIVE REPORTED THAT 2 EVEREST MI PROVISIONAL SPLIT DRIVERS; SIZE 30 FAILED TO LOOSEN FROM SET SCREW AFTER INSERTION. SURGERY WAS SUCCESSFULLY COMPLETED AFTER A 2.5 HOUR DELAY. THIS REPORT CAPTURES THE SECOND OF TWO SCREWDRIVERS.

  Patient problems: Injury

  MAUDE report 9850490 ↗
• InjuryMar 18, 2020Mechanical Jam; Mechanical Jam

  STRYKER REPRESENTATIVE REPORTED THAT 2 EVEREST MI PROVISIONAL SPLIT DRIVERS; SIZE 30 FAILED TO LOOSEN FROM SET SCREW AFTER INSERTION. SURGERY WAS SUCCESSFULLY COMPLETED AFTER A 2.5 HOUR DELAY. THIS REPORT CAPTURES THE FIRST OF TWO SCREWDRIVERS.

  Patient problems: Injury

  MAUDE report 9850482 ↗