MOUNTAINEER 188318328Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034157252), received between May 15, 2018 and Oct 25, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionOct 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE INNER SCREW OF THE SCREW BACKED OUT - COULD NOT INSERTER THE SCREW. PATIENT CONSEQUENCE? : NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006344 ↗
• MalfunctionMay 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, THE SURGERY FOR THE CERVICAL OPLL WAS PERFORMED BY USING THE MOUNTAINEER SYSTEM. THE FIXED AREA WAS C2 ¿ 5. THE REPORTED FAVORED ANGLE SCREW WAS USED WHEN THE SURGEON WAS INSERTING THE C2 LAMINA SCREW. WHEN THE SURGEON INSTALLED THE SCREW TO THE DRIVER, THERE WAS NO PROBLEM. WHEN THE SURGEON REMOVED THE SCREW FROM THE SCREW DRIVER, SINCE THE SURGEON PUSHED THE BUTTON ON THE DRIVER INNER PORTION, THE SCREW COULD NOT BE DETACHED FROM THE SCREW DRIVER. THE SURGEON INSTALLED THE SCREW TO THE SCREW DRIVER AGAIN. HOWEVER, THE SURGEON PUSHED THE BUTTON ON THE DRIVER INNER PORTION THREE TIMES AND REPEATED THE SCREW INSTALLATION, THE INNER PART OF THE SCREW HEAD WAS COME UP; THUS, THE SURGEON COULD NOT PLACE THE CORE DRIVER OR THE ROD ANYMORE. THE SURGERY WAS COMPLETED WITH A 30-MINUTE-DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7515767 ↗