N/A 7480109Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885074136905), received between Apr 24, 2023 and Feb 13, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333029 ↗
• MalfunctionFeb 13, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332927 ↗
• MalfunctionMar 17, 2025Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY AT LEVELS T10-S1 FOR LUMBAR REVISION. IT WAS REPORTED THAT THE DRIVERS WERE STRIPPED/BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21616860 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT  THE DRIVER BROKE AND HAD COME APART WHEN IT WAS GETTING READY TO STERILIZE. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366825 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR CENTRAL STENOSIS THORACIC SPINE. IT WAS REPORTED THAT THE TIP FELL OFF. WHATEVER PIECE LOCKS IT IN PLACE WAS MISSING. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354366 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR POSTERIOR FIXATION. IT WAS REPORTED THAT THE SCREWDRIVER SHAFT WAS BROKEN. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354034 ↗
• MalfunctionJan 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A DRIVER TO BE SUED IN A POSTERIOR FIXATION. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTI CIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272305 ↗
• MalfunctionApr 24, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING LUMBAR ARTHRODESIS. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. NO PATIENT SYMPTOMS. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED BECAUSE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795074 ↗