MOUNTAINEER 188341100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034158662), received between Nov 10, 2017 and Nov 24, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE POSTERIOR CERVICAL FUSION (C1) WITH THE OUTER NUT IN QUESTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2021, IT WAS CONFIRMED BY X-RAY, THAT THE OUTER NUT CAME OFF AT FOLLOW-UP JUST BEFORE DISCHARGE. ACCORDING TO THE VIDEO TAKEN DURING THE SURGERY, THE OUTER NUT WAS PROPERLY TIGHTENED WITH THE TORQUE DRIVER FOR THE FINAL TIGHTENING. AFTER THE SURGERY, THE PATIENT HAS BEEN UNDERGOING REHABILITATION. THIS REPORT IS FOR ONE (1) MNTR H/H X-CONN OUTER NUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869016 ↗
• MalfunctionDec 11, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  (B)(6). ON (B)(6) 2017, SURGERY WAS PERFORMED USING THE MOUNTAINEER SYSTEM. EXPEDIUM HEAD-TO-HEAD CROSS CONNECTOR WAS PLACED TO FIX C2-C3. IN (B)(6) 2017 AFTER THE PATIENT LEFT THE HOSPITAL, NO LOOSENING OF THE OUTER NUT WAS CONFIRMED THROUGH AN X-RAY. IN (B)(6) 2017, HOWEVER, IT WAS CONFIRMED THAT THE OUTER NUT (PART#: 188341100, LOT#: UNKNOWN) COMPLETELY COME OFF ON ITS RIGHT SIDE. SURGICAL RE-OPERATION IS NOT SCHEDULED SO FAR.

  Patient problems: Spinal Column Injury

  MAUDE report 7105798 ↗
• MalfunctionDec 11, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  (B)(6). ON (B)(6) 2017, SURGERY WAS PERFORMED USING THE MOUNTAINEER SYSTEM. EXPEDIUM HEAD-TO-HEAD CROSS CONNECTOR WAS PLACED TO FIX C2-C3. IN (B)(6) 2017 AFTER THE PATIENT LEFT THE HOSPITAL, NO LOOSENING OF THE OUTER NUT WAS CONFIRMED THROUGH AN X-RAY. IN (B)(6) 2017, HOWEVER, IT WAS CONFIRMED THAT THE OUTER NUT (PART#: 188341100, LOT#: UNKNOWN) COMPLETELY COME OFF ON ITS RIGHT SIDE. SURGICAL RE-OPERATION IS NOT SCHEDULED SO FAR.

  Patient problems: Spinal Column Injury

  MAUDE report 7105687 ↗
• MalfunctionNov 10, 2017Torn Material; Torn Material

  WHEN TORQUING DOWN THE OUTER NUT ON THE H/H CONN PLATE, THE DRIVER AND NUT KEPT SHEARING OFF THE TOP OF THE INNER SCREW. THE SURGEON WAS NOT ABLE TO USE THE H/H CONN PLATE IN HIS CONSTRUCT BECAUSE OF THIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7017543 ↗