Gauthier Biomedical G900100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858325005015), received between Aug 12, 2021 and Aug 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionAug 12, 2021Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING SPINAL INSTRUMENTS DURING A L1-S1 REVISION AND FUSION. IT WAS REPORTED THAT THE DOCTOR WAS USING A MALLET TO ADVANCE THE THORACIC PROBE THROUGH THE PEDICLE AND INTO THE VERTEBRAL BODY FOR SCREW PREPARATION. AFTER MALLETING THE PROBE, THE DOCTOR REMOVED IT AND NOTICED THE TIP OF THE PROBE BROKE OFF AT THE 10MM MARK. THE DOCTOR USED THE PASSIVE PLANAR PROBE AND PLACED IT DOWN THE HOLE THE TIP WAS LOCATED IN. THE DOCTOR CONCLUDED THE TIP OF THE BROKEN PROBE WAS TOO FAR INTO THE VERTEBRAL BODY TO RETRIEVE IT WITHOUT CAUSING HARM TO THE PATIENT. IT WAS NOTED THAT AROUND 10MM OF THE TIP OF THE THORACIC PROBE WAS LEFT IN THE PATIENT AS THE PHYSICIAN CONCLUDED THEY WOULD CAUSE MORE HARM TRYING TO RETRIEVE IT THEN IF THEY LEFT IT. THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE USE OF MEDTRONIC PRODUCTS WAS UNKNOWN. THE PATIENT STATUS WAS ALIVE WITH NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12316414 ↗