EVEREST Spinal System 5101-90012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857104006), received between Jun 26, 2020 and Aug 8, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2022Material Deformation; Failure to Eject; Material Deformation; Failure to Eject

  IT WAS REPORTED THAT THE EVEREST MI OFFSET ROD REDUCER WAS DIFFICULT TO COME OFF OF THE SCREW AND WAS BROKEN/BENT WHEN ATTEMPTING TO REMOVE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15185999 ↗
• MalfunctionMay 11, 2021Use of Device Problem; Material Deformation; Naturally Worn; Use of Device Problem; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT 2 EVEREST MI OFFSET ROD REDUCERS SHOWED SIGNS OF MATERIAL WEAR AND WERE NOT RETAINING THE SCREW HEADS OUTSIDE OF THE OR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE SECOND OF THE TWO REDUCERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807255 ↗
• MalfunctionMay 11, 2021Use of Device Problem; Material Deformation; Naturally Worn; Use of Device Problem; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT 2 EVEREST MI OFFSET ROD REDUCERS SHOWED SIGNS OF MATERIAL WEAR AND WERE NOT RETAINING THE SCREW HEADS OUTSIDE OF THE OR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE FIRST OF THE TWO REDUCERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807253 ↗
• InjuryJun 26, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHILE TRYING TO PLACE A TEMPORARY ROD IN PREPARATION FOR TLIF, AN EVEREST MI SINGLE ACTION ROD REDUCER TIP FRACTURED AND BECAME STUCK ON AN EVEREST POLAYAXIAL SCREW AT THE L5 LEVEL. THE SURGEON WAS ABLE TO GET THE REDUCER OFF OF THE SCREW WITH AGGRESSIVE FORCE. AFTER TLIF, THE SURGEON TRIED TO REDUCE THE SAME LEFT L5 SCREW WHILE ATTEMPTING TO PLACE THE FINAL RODS. BOTH BASECAMP ROD REDUCERS POPPED OFF OF THE SCREW ONCE THEY WERE FULLY REDUCED. THE SURGEON THEN TRIED TO USE A DENALI AND AN EVEREST MI OFFSET ROD REDUCER, BUT THEY ALSO POPPED OFF. IT WAS DETERMINED THAT THE SCREW WAS BENT AND IT WAS REMOVED AND REPLACED WITH A NEW ONE. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER REDUCER AND AN HOUR AND A HALF DELAY. THIS REPORT REPRESENTS EVEREST MI OFFSET ROD REDUCER.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10200164 ↗