MOUNTAINEER 188363200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034159027), received between Jun 27, 2018 and Jun 27, 2018 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2018Break; Break

  IT WAS REPORTED THAT ,THE TWO MOUNTAINEER RODS WERE IMPLANTED 2 YEARS AGO ON FEMALE PATIENT (B)(6). DIAGNOSIS: BROKEN RODS PREVIOUS IMPLANTED 2 YEARS PRIOR FROM THE OCCIPUT TO C5 POSTERIOR FUSION. THE RODS BROKE. THE PATIENT PRESENTED WITH DIABETES AS A COMORBIDITY. THE 2 RODS WERE EXPLANTED FOR NEW RODS ON (B)(6) 2018. PATIENT EXPOSED TO ADDITIONAL 90 MINUTES OF ANESTHESIA AS A RESULT. DR (B)(6) WOULD LIKE (B)(6), PHD ENGINEER TO INSPECT THE EXPLANTED RODS.

  Patient problems: Spinal Column Injury

  MAUDE report 7641457 ↗
• InjuryJun 27, 2018Break; Break

  IT WAS REPORTED THAT ,THE TWO MOUNTAINEER RODS WERE IMPLANTED 2 YEARS AGO ON FEMALE PATIENT D.O.B (B)(6). DIAGNOSIS : BROKEN RODS PREVIOUS IMPLANTED 2 YEARS PRIOR FROM THE OCCIPUT TO C5 POSTERIOR FUSION. THE RODS BROKE. THE PATIENT PRESENTED WITH DIABETES AS A COMORBIDITY. THE 2 RODS WERE EXPLANTED FOR NEW RODS ON (B)(6) 2018. PATIENT EXPOSED TO ADDITIONAL 90 MINUTES OF ANESTHESIA AS A RESULT. DR (B)(6) WOULD LIKE (B)(6), PHD ENGINEER TO INSPECT THE EXPLANTED RODS.

  Patient problems: Spinal Column Injury

  MAUDE report 7641242 ↗