Spine Instruments 03.75.10.0069Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971208940), received between Aug 10, 2023 and Aug 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionAug 10, 2023Fracture; Fracture

  DURING THE PRIMARY SPINE SURGERY, WHEN THE SURGEON WAS CUTTING THE COCR ROD WITH A ROD CUTTER, A PIECE OF THE ROD CUTTER FLEW INTO THE AIR AND HIT THE OR LIGHT WHICH SHATTERED AND RESULTED IN PIECES OF GLASS FALLING INTO THE STERILE FIELD. THE OR LIGHT WAS REMOVED AND THE SURGEON BACKED OUT OF THE OR AND SCRUBBED IN AGAIN, IRRIGATED THE PATIENT EXTENSIVELY AND APPLIED AN ANTIMICROBIAL WOUND LAVAGE TO THE OPEN INCISION. THE SURGEON HAD TO USE COMPETITOR ROD CUTTER TO COMPLETE THE CASE. THERE WAS 30-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498529 ↗