MOUNTAINEER 188318312Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034157177), received between Jun 24, 2020 and Jul 21, 2021 — classified as 7 injuries.

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 7 most recent of 7 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 12MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 12203842 ↗
• InjuryJun 24, 2020Adverse 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 AN UNKNOWN DATE THAT THE PATIENT UNDERWENT THE REMOVAL OF A SPINE CONSTRUCT THAT WAS INITIALLY IMPLANTED ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT WAS PLACED IN A BRACE FOLLOWING THE PROCEDURE. THE PATIENT HAS POOR BONE QUALITY AND TERMINAL CANCER. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10191165 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 X 3.5 X 12MM.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10191073 ↗
• InjuryJun 24, 2020Adverse 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 AN UNKNOWN DATE THAT THE PATIENT UNDERWENT THE REMOVAL OF A SPINE CONSTRUCT THAT WAS INITIALLY IMPLANTED ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT WAS PLACED IN A BRACE FOLLOWING THE PROCEDURE. THE PATIENT HAS POOR BONE QUALITY AND TERMINAL CANCER. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10191034 ↗
• InjuryJun 24, 2020Adverse 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 AN UNKNOWN DATE THAT THE PATIENT UNDERWENT THE REMOVAL OF A SPINE CONSTRUCT THAT WAS INITIALLY IMPLANTED ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT WAS PLACED IN A BRACE FOLLOWING THE PROCEDURE. THE PATIENT HAS POOR BONE QUALITY AND TERMINAL CANCER. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10190997 ↗
• InjuryJun 24, 2020Adverse 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 AN UNKNOWN DATE THAT THE PATIENT UNDERWENT THE REMOVAL OF A SPINE CONSTRUCT THAT WAS INITIALLY IMPLANTED ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT WAS PLACED IN A BRACE FOLLOWING THE PROCEDURE. THE PATIENT HAS POOR BONE QUALITY AND TERMINAL CANCER. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10190933 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A REMOVAL SURGERY OF A SPINE CONSTRUCT DUE TO INFECTION ON (B)(6) 2020, THE SURGEON WAS PLACED THE PATIENT IN A BRACE DUE TO POOR BONE QUALITY AND TERMINAL CANCER. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS UNKNOWN IF THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) MNTR F/A SCREW 3.5X12. THIS IS REPORT 1 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINTS: (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10190798 ↗