N/A 5480140VRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994429780), received between Oct 27, 2022 and Apr 24, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, PRIOR TO USE AND WITH NO PROCEDURE PERFORMED AND NOTHING IMPLANTED, THE SET SCREWDRIVER DID NOT STAY LOCKED WHEN EXPANDED AND COLLAPSED BACK DOWN. THE PRODUCTS WERE REPORTED TO HAVE BEEN UTILIZED CORRECTLY ACCORDING TO THE INSTRUCTIONS FOR USE/LABELING, AND THERE WAS NO PATIENT INVOLVED IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982133 ↗
• MalfunctionDec 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING DEVICES USED IN A SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICES WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766827 ↗
• MalfunctionJan 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED IN TLIF. IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21155650 ↗
• MalfunctionMay 14, 2024Break; Break

  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 19309128 ↗
• MalfunctionFeb 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION. IT WAS REPORTED THAT DURING INTRA-OP, THE DRIVER SNAPPED IN TWO PIECES. THERE WERE NOPATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18786270 ↗
• MalfunctionOct 27, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS USED IN UNKNOWN SPINAL THERAPY FOR SPINAL INSTRUMENTATION FAILURE. IT WAS REPORTED THAT THE DRIVER TIP SNAPPED OFF WHEN REMOVING SCREW, DRIVER WAS BINDING UP, DRIVER TIP WAS STRIPPED WHILE REMOVAL, STOPPING PIN MECHANISM OF THE HANDLE WAS BROKEN, DRIVER TIP WAS STRIPPED, RATCHETING HANDLE STOPPED RATCHETING PROPERLY AND WAS BINDING UP, RATCHETING DIRECTIONAL RING SEPARATED FROM HANDLE, DRIVER TIP SNAPPED OFF WHILE REMOVING A SCREW. THERE ARE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15678261 ↗