Gauthier Biomedical G170059Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858325005091), received between Jun 30, 2022 and Jun 30, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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

• MalfunctionJun 30, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INSTRUMENT COULD NOT BE ENGAGED TO OTHER INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14874288 ↗