EVEREST Spinal System 5101-90161Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888857279414), received between Sep 11, 2020 and Sep 11, 2020 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN EVEREST XT LOCKING SCREW INSERTER WAS "CLICKING" AND KEPT LOOSENING FROM THE SCREW INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER INSERTER AND A 20 MINUTE SURGICAL 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 10521797 ↗