EVEREST Spinal System 2901-90110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857040663), received between Jun 25, 2020 and Aug 1, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE EVEREST DEFORMITY ROD REDUCER BASE CAMP WOULD NOT GRAB THE SCREW HEAD INTRA-OPERATIVELY AND AFTER THE CASE IT WAS NOTICED THAT THE PORTIONS THAT GRAB THE SCREW HEAD WERE SPLAYED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138361 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 THE SECOND OF TWO BASCAMP ROD REDUCERS.

  Patient problems: Injury

  MAUDE report 10197655 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 THE FIRST OF TWO BASECAMP ROD REDUCERS.

  Patient problems: Injury

  MAUDE report 10197653 ↗