MOUNTAINEER 288310045Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034221687), received between Nov 17, 2022 and Nov 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionNov 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHEN PREPARING FOR A SPINAL FUSION PROCEDURE FOR A C1 FRACTURE, IT WAS FOUND THAT A SUBSTANCE SUCH AS BONE DEBRIS WAS ADHERING TO THE SCREW IN QUESTION. THE SCREW HAD BEEN CLEANSED AND STERILIZED AT THE HOSPITAL THE DAY BEFORE THE OPERATION. THE SUBSTANCE WAS REMOVED, AND THE SCREW WAS CLEANSED AND STERILIZED. THE SCREW WAS USED FOR THE OPERATION, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THIS EVENT DID NOT AFFECT THE OPERATION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL TAP 4.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15813391 ↗