N/A 5584002Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169064133), received between Nov 6, 2024 and Nov 18, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR SPINAL FUSION THERAPY. LEVELS IMPLANTED L4-5. IT WAS REPORTED THAT A PART OF THE SHAFT IN THE MIDDLE OF THE DRIVER WAS BROKE OFF BEFORE THE SURGERY STARTED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581036 ↗
• MalfunctionJan 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING TWO DRIVERS USED FOR SPINAL FUSION WITH TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT BOTH DRIVERS BROKE. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE DRIVERS BROKE WHILE TRYING TO SNAP OFF SET SCREW DURING PROCEDURE. PRE-OP DIAGNOSIS UNKNOWN. PATIENT WAS INVOLVED IN THE EVENT. PRODUCT CAME IN CONTACT WITH THE PATIENT. BUT THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21236335 ↗
• MalfunctionJan 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED IN TLIF. IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED. THE ITEMS BECAME DAMAGED AND WORN OUT OVER TIME IN SPD. 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 21155662 ↗
• MalfunctionJan 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED IN TLIF. IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED. THE ITEMS BECAME DAMAGED AND WORN OUT OVER TIME IN SPD. 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 21155432 ↗
• MalfunctionNov 6, 2024Break; Naturally Worn; Break; Naturally Worn

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (QUALITY INSPECTOR) REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP WAS BROKEN AND INSTRUMENT WAS WORN. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619834 ↗