Spine Instruments 03.22.10.7041Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971235847), received between Feb 26, 2020 and Feb 26, 2020 — classified as 1 injury.

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 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.

• InjuryFeb 26, 2020Break

  DURING THE PRIMARY SPINE SURGERY, WHILE THE SURGEON WAS PERFORMING L4/5 POSTERIOR LUMBER FUSION, AND WHEN PLACING BOTH THE L4/5 GUIDES, THE SURGEON HAD PLANNED TO PLACE 45MM SCREWS IN L4 AND 40 MM SCREWS IN L5 DUE TO THE TRAJECTORY FROM THE DRILLS HE WAS ONLY ABLE TO PLACE 35 MM SCREWS. IN ADDITION, WHEN THE SURGEON WENT TO CHECK AP FLUOROSCOPY PLACEMENT OF THE L4 RIGHT SIDED PEDICLE HE NOTICED A MEDIAL BREAK OF THE PEDICLE. THE SURGEON HAD DRILLED AND PLACED PEDICLE MARKERS, WHEN THIS WAS FOUND. AFTER PERFORMING HIS DECOMPRESSION, HE WENT BACK AND REVISED THE L4 SCREW TRAJECTORY WITH A FREE HAND APPROACH. THE TOTAL DELAY WITH THE GUIDES AND REPLACEMENT OF THE L4 SCREW WAS 20 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9755013 ↗