MOUNTAINEER 188318314Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034157184), received between Aug 25, 2017 and Jul 21, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018 THE PRIMARY POSTERIOR FUSION AT C3/4 WAS PERFORMED. ON (B)(6) 2021 A REVISION PROCEDURE (DEPRESSION AND C3-C6 EXTENSION) WAS PERFORMED TO TREAT AN ADJACENT DISORDER. THE SURGEON CONFIRMED THAT ANY PRODUCT DEFECTIVENESS WAS NOT THE CAUSE OF THE REVISION PROCEDURE. THIS REPORT IS FOR ONE (1) MINI POLYAXIAL BONE SCREW 3.5 X 3.5 X 14MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12203906 ↗
• MalfunctionFeb 9, 2018Torn Material; Torn Material

  IT WAS REPORTED SURGEON COULD NOT FINAL TIGHTEN THE OUTER NUTS ON TOP OF THE CROSSLINK BECAUSE THE TALL SET SCREW THREADS HAD BEEN SHEARED AND HE COULD NOT FINAL TIGHTEN THE INNER CROSSLINK SET SCREW. APPEARS THE SCREW AND THE INNER SET SCREW WERE CROSS THREADED.

  Patient problems: Not Applicable

  MAUDE report 7260645 ↗
• MalfunctionFeb 9, 2018Torn Material; Torn Material

  IT WAS REPORTED SURGEON COULD NOT FINAL TIGHTEN THE OUTER NUTS ON TOP OF THE CROSSLINK BECAUSE THE TALL SET SCREW THREADS HAD BEEN SHEARED AND HE COULD NOT FINAL TIGHTEN THE INNER CROSSLINK SET SCREW. APPEARS THE SCREW AND THE INNER SET SCREW WERE CROSS THREADED.

  Patient problems: Not Applicable

  MAUDE report 7260622 ↗
• InjuryJan 29, 2018Break; Break

  BROKEN RIGHT POSTERIOR CERVICAL LATERAL MASS 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: Spinal Column Injury

  MAUDE report 7224566 ↗
• MalfunctionAug 25, 2017Break; Break

  ON (B)(6) 2017, SURGERY WAS PERFORMED USING THE MOUNTAINEER SYSTEM. THE FIXED AREA WAS C3 ¿ T2. DURING THE SURGERY, WHEN THE SURGEON INSERTED THE FOLLOWING SCREW TO C3 (RIGHT), HE NOTICED THAT THE COLLET WAS DROPPED OFF. - FAVORED ANGLE SCREW 3.5 X 14 (PART#: 188318314, LOT#: ARMFV7). HE DID NOT PULL OUT THE DRIVER SMOOTHLY, HE TRIED TO PULL IN AND OUT THE DRIVER A COUPLE OF TIMES. BUT HE DID NOT UNDERSTAND WHY THIS ISSUE HAPPENED. HE DEALT WITH THIS EVENT BY REPLACING THE SCREW IN QUESTION WITH A NEW ONE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY, AND HERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6821188 ↗