EVEREST Spinal System 2901-N90006Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888857041059), received between Sep 9, 2019 and Sep 9, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 9, 2019Device-Device Incompatibility; Device-Device Incompatibility

  K2M WAS COPIED ON A LETTER FROM A COMPETITOR TO THE FDA THAT ALLEGED THAT, DURING A SPINE FUSION PROCEDURE, A K2M DRIVER WAS BEING USED WITH THE COMPETITORS NAVIGATION SYSTEM, MALFUNCTIONED DURING SURGERY (COMPETTITOR LETTER). ACCORDING TO THE COMPETTITOR LETTER, NO PATIENT HARM OCCURED. THE LETTER DID ALLEGE, THOUGH THAT DURING THE SURGERY THERE WAS INACCURATE SCREW PLACEMENT AND FURTHER ALLEGED THAT SUCH PLACEMENT RESULTED FROM A K2M DRIVER BEING USED WITH THE COMPETTITOR NAVIGATION SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8977605 ↗