N/A 6630904Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169363496), received between Jan 9, 2019 and Mar 4, 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.

• MalfunctionMar 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT TIP OF DRIVER BROKE WHILE LOCKING A SCREW. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512261 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT DRIVERS WERE STRIPPED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. (B)(6) 2023 E1 (REP): PRODUCT CAME IN CONTACT WITH PATIENT, PROCEDURE WAS C3-5 ACDF CORPECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362288 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE PART OF THE TIP OF ONE OF THE REPORTED DRIVERS BROKE OFF WHILE THE SURGEON WAS TRYING TO LOCK THE PLATE. THE PIECE WAS RECOVERED AND DISCARDED. NO PART OF THE INSTRUMENT REMAINS IN THE PATIENT. THE OTHER TWO DRIVERS WERE STRIPPED. THE PROCEDURE WAS COMPLETED WITH NEW DRIVERS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301338 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING THE DRIVERS USED IN THE C5-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY FOR DEGENERATIVE DISC DISEASE AT C5-7. IT WAS REPORTED THAT THE TIP OF THE T8 DRIVER WAS BROKEN OFF DURING AN ATTEMPT TO LOCK THE ZEVO LOCK PLATE. THE TIP WAS NOT RECOVERED BUT MOST LIKELY WAS SUCKED UP INTO THE SUCTION. NO PIECE OF THE DRIVER WAS FOUND IN THE PATIENT. THE ZEVO DRIVERS WAS STRIPPED AND NO LONGER USABLE WHILE IMPLANTING ZEVO SCREWS. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293491 ↗
• MalfunctionJan 9, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE. DURING SURGERY, THE TIP OF THE DRIVER BROKE. THE TIP OF THE DRIVER IS STILL IN THE PLATE, LOCATED IN THE PATIENT. THE SURGEON WAS NOT ABLE TO REMOVE THE BROKEN TIP DURING THE PROCEDURE. THERE WILL NOT BE ANY SUBSEQUENT SURGERY TO RECOVER THE BROKEN TIP AS IT IS LODGED DIRECTLY INTO THE IMPLANT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8230136 ↗