N/A 6640005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169492516), received between May 7, 2021 and Feb 12, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT UNDERGOING UNKNOWN SPINE SURGERY. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN WHILE ADJUSTING A SCREW. DOCTOR WAS ABLE TO RETRIEVE THE PIECE OF THE DRIVER. NO HARM TO THE PATIENT OR DELAY TO THE CASE. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED DUE TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT PROCEDURE USED IN THIS EVENT WAS TLIF AND PRE OP DIAGNOSIS OF THIS EVENT WAS SPINAL STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362105 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-1 HARDWARE R EMOVAL FOR AN INDICATION OF PSEUDOARTHROSIS. IT WAS REPORTED THAT THE TIP OF THE INTRUMENTS BROKEN OFF WHILE REMOVING THE PREVIOUS HARDWARE. 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 21289769 ↗
• MalfunctionJul 3, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING FRONT/POSTERIOR FUSION AND VERTEBRAL BODY REPLACEMENT. IT WAS REPORTED THAT THE TIP BROKE WHEN ATTEMPTING TO TIGHTEN THE SET SCREW. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. 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 19663949 ↗
• MalfunctionMay 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CASE OF REDO RIGHT L2-3, LEFT L5-S1 DECOMPRESSION AND TRANSFORAMINAL LUMBAR INTERBODY FUSION AND REMOVAL OF PREVIOUS SCREWS AT L3-4-5, RESTABILIZATION AT L2-3-4-5-1 WITH POSTEROLATERAL FUSION FROM L2-S1 IT WAS REPORTED THAT WE PULLED OUT A 6.5X45 GLOBUS SCREW FROM RIGHT L5. THE SURGEON UPSIZED TO A 7.5X45, AND WENT STRAIGHT TO A VOYAGER 4.75 ATS SCREW. HE WAS STANDING ON THE PATIENTS LEFT SIDE REACHING ACROSS AND DOING THE RIGHT SIDED SCREW. THE ANGLE HE HAD IT IN WAS QUITE LATERAL. THE SCREW BECAME DIFFICULT TO ADVANCE, AND THEN ALL AT ONCE THE DRIVER JUST SPUN INSIDE THE TULIP BECAUSE THE TIP HAD BROKEN OFF IN IT. WE TRIED SEVERAL METHODS TO GET THE BROKEN SCREWDRIVER TIP OUT OF THE TULIP, AND TRIED TO HELICOPTER THE SCREW OUT ALTOGETHER USING A SHORT ROD AND SETCAP. WHAT WE ENDED UP HAVING TO DO WAS USE A METAL CUTTING BURR TO DRILL OUT THE BROKEN OFF PART OF THE SCREWDRIVER, AND THEN WE WERE ABLE TO BACK OUT THE SCREW USING THE HELICOPTER METHOD FROM ABOVE. THIS HAPPENED WITH FIRST THE NAVIGATED DRIVER, AND THEN A SHORT NON RETAINING DRIVER AS WELL BEFORE WE GOT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789002 ↗