EVEREST® Spinal System 2911-06545Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857042339), received between Apr 5, 2017 and Jun 25, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2020Material Deformation; Material Deformation

  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 AN EVEREST MI OFFSET ROD REDUCER, BUT IT 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 SCREW.

  Patient problems: Injury

  MAUDE report 10197603 ↗
• InjuryApr 5, 2017Break; Break

  ON (B)(6) 2017, IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A POSSIBLE SCREW BREAK. THE PATIENT REPORTEDLY HAD POSSIBLE SCREW BREAK APPROXIMATELY 5 MONTHS POST-OP. THERE ARE NO PLANS TO REVISE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 6460280 ↗