Brainlab Compatible K2M Navigation Instruments 2901-N90098-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857405486), received between Jul 5, 2022 and Jan 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 30, 2023Material Deformation; Material Deformation

  THIS RECORD IS A CONSOLIDATION OF Q4 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE EVEREST LOCKING SCREW INSERTER TIP DEFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264994 ↗
• MalfunctionJul 5, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF AN EVEREST LOCKING SCREW INSERTER BECAME DEFORMED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915330 ↗