MOUNTAINEER 188320332Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034158143), received between May 3, 2019 and Mar 16, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionMar 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN ARCUS POSTERIOR ABLATION (C1) AND FUSION (C1/2) TREATING MYELOPATHY, THE SURGEON WAS UNABLE TO DETACH THE SCREWDRIVER FROM THE SCREW. THE SURGEON TURNED THE SCREWDRIVER CLOCKWISE AND COUNTERCLOCKWISE, THE SCREWDRIVER FINALLY DETACHED, BUT INNER COMPONENT OF THE SCREW CAME OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 X 3.5 X 32MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494819 ↗
• InjuryJul 20, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2020 THE PATIENT HAD A FALL AND FELL FACE FIRST RESULTING IN THE BREAKING OF MOUNTAINEER SCREWS AT C1 AND C2 MIDSHAFT. A REVISION SURGERY IS PENDING THE MRI AND CT RESULTS. CONCOMITANT DEVICES: UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN OCCIPITAL PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 X 3.5 X 32MM THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant; Injury

  MAUDE report 10296017 ↗
• InjuryJul 20, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT HAD A FALL AND FELL FACE FIRST RESULTING IN THE BREAKING OF MOUNTAINEER SCREWS AT C1 AND C2 MIDSHAFT. A REVISION SURGERY IS PENDING THE MRI AND CT RESULTS. CONCOMITANT DEVICES: UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN OCCIPITAL PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 X 3.5 X 32MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant; Injury

  MAUDE report 10295795 ↗
• InjuryMay 3, 2019Break; Break

  THE FOLLOWING WAS REPORTED: PROBLEM WITH NECK SCREWS MOUNTAINEER, PRODUCT 1883-20-332, QUANTITY - 2 PCS. OPERATION DATE - (B)(6) 2019. HOSPITAL - OPERATING ROOM OF THE NEUROSURGERY UNIT OF (B)(6) INSTITUTE OF AMBULANCE BY (B)(6). PROBLEM DESCRIPTION: NECK SCREWS WERE IMPLANTED IN 2018, AND AFTER ONE YEAR THEY WERE BROKEN IN PATIENT. ON (B)(6) 2019 BROKEN SCREWS WERE REMOVED.

  Patient problems: No Code Available

  MAUDE report 8578926 ↗
• InjuryMay 3, 2019Break; Break

  THE FOLLOWING WAS REPORTED: PROBLEM WITH NECK SCREWS MOUNTAINEER, PRODUCT 1883-20-332, QUANTITY - 2 PCS. OPERATION DATE- (B)(6) 2019. HOSPITAL - OPERATING ROOM OF THE NEUROSURGERY (B)(6) BY (B)(6). PROBLEM DESCRIPTION: NECK SCREWS WERE IMPLANTED IN 2018, AND AFTER ONE YEAR THEY WERE BROKEN IN PATIENT. ON (B)(6) 2019 BROKEN SCREWS WERE REMOVED.

  Patient problems: No Code Available

  MAUDE report 8578873 ↗