MOUNTAINEER 288303000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034221281), received between May 13, 2024 and May 13, 2024 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A POSTERIOR FUSION OF OCCIPITAL AND CERVICAL VERTEBRAE (CERVICAL VERTEBRAE) ON (B)(6) 2024, WITH SYMPHONY-OC. IN THE SURGERY, THE DEPTH GAGE IN QUESTION WAS USED FOR OC SCREW INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2024, CEREBELLAR HEMORRHAGE OCCURRED, AND REVISION SURGERY WAS PERFORMED IN THE NEUROSURGERY DEPARTMENT. NO IMPLANT WAS REMOVED. THE SURGEON'S OPINION WAS CONFIRMED WHICH AN ANTERIOR PERFORATION MAY HAVE OCCURRED BY THE DEPTH GAGE DURING THE SURGERY ON (B)(6) 2024. THE PATIENT IS CURRENTLY UNDER FOLLOW UP AND STABLE. THIS REPORT IS FOR A DEPTH GAGE W/BALLTIP PROBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19305579 ↗