MOUNTAINEER 288305300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034221380), received between Jul 7, 2015 and Nov 19, 2021 — classified as 2 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 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.

• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE MNTR ROD CLAMP WAS DISCOVERED BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MOUNTAINEER ROD CLAMP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843779 ↗
• MalfunctionJul 7, 2015Break

  PER SYNTHES (B)(4): A VOICEMAIL WAS RECEIVED FROM (B)(6) THIS AFTERNOON. HE WAS CALLING TO REPORT A COMPLAINT REGARDING A CASE OF (B)(6) 2015 INVOLVING PART # (B)(4)/ LOT# 0305K (ROD CLAMP). HE WOULD LIKE TO BE CONTACTED REGARDING HIS RETURN AND REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. PLEASE CONTACT. PER COMPLAINT FORM: SURGEON WAS USING MOUNTAINEER ROD HOLDER IN ITS NON-INTENDED WAY BY TORQUING/BENDING A ROD. ROD HOLDER WAS GRIPPED ONTO AN OFFSET CONNECTOR AND IN SITU BENDER ON OTHER SIDE OF OFFSET CONNECTOR WITH AN AGGRESSIVE OPPOSITE DIRECTION MANEUVER BETWEEN INSTRUMENTS THE ROD HOLDER FAILED AND TIP FRACTURED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 4896430 ↗