n/a 6550006Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169754539), received between May 5, 2021 and Dec 31, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS 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 23931712 ↗
• MalfunctionOct 17, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING CASE SETUP, THE DRIVER AND REDUCER WAS IDENTIFIED AS BROKEN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323592 ↗
• MalfunctionSep 8, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR SPINAL THERA PY. IT WAS REPORTED THAT SET SCREW WILL NOT STAY ON THE DRIVER. SMALL METAL PIECE AT TIP HAS BROKEN OFF. 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 22992180 ↗
• MalfunctionMay 4, 2025Break; Mechanical Problem; Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE NUT ON THE DRIVER WAS SEIZED, PREVENTING IT FROM BEING TAKEN APART AND CLEANED PROPERLY. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT DEVICE IS BROKEN. THE THREADED NUT PIECE IS SEIZED ON THE HANDLE PREVENTING THE DEVICE FROM COMING APART AND BEING CLEANED PROPERLY CAUSING THE REST OF THE INSTRUMENT TO SEIZE WHILE PUTTING THE SET SCREW ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21956793 ↗
• MalfunctionMar 6, 2025Break; Break

  INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING A SPINAL THERAPY. IT WAS REPORTED THAT, THE INSTRUMENT WAS BROKEN. THERE WERE NO PATIENT INVOLVED, NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536845 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF A DRIVER BROKE OFF COMING OUT OF THE WASH IN DECONTAMINATION. NO ADVERSE EVENT OCCURRED TO THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362759 ↗
• MalfunctionFeb 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING DRIVERS, ROD INSERTER, REDUCER, PEDICLE MARKER, AND A PROBE HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS 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 21320676 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING A DRIVER AND CLAMP PRIOR TO USE. IT WAS REPORTED THAT THE CLAMP WAS NOT WORKING AND THE TIP OF THE DRIVER WAS BROKEN OFF. 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 21301057 ↗
• MalfunctionFeb 3, 2025Break; Component Missing; Break; Component Missing

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WAS BROKEN AND INSTRUMENT WAS FOUND TO BE MISSING THE CRITICAL NUT THAT HOLDS ITS 3 PIECE DESIGN TOGETHER. INSTRUMENT WAS FOUND IN ROUTINE DEVICE SERVICING CHECK. NO PATIENT OR DOCTOR WAS INVOLVED. PRODUCT WILL BE RETURNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290139 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT FOR THE INSERTER THE WELD THAT HOLDS THE HANDLE TO THE INSERTER SHAFT HAS COME LOOSE AND PRODUCT IS IN 2 SEPARATE PIECES. FOR A DRIVER, THE INNER DEVICE THAT GOES INSIDE THE INSERTER IS NO LONGER EXTENDING TO ALLOW THE PRODUCT TO GRASP A SET SCREW. FOR A DRIVER, A PORTION OF THE TIP OF THE INSERTER HAS BROKEN OFF AND THE INSERTER WILL NO LONGER GRASP A SET SCREW. NONE OF THE PROBLEMS WITH THE INSTRUMENTS OCCURRED DURING SURGERY AND THERE WAS NOT PATIENT INVOLVED WITH ANY OF THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280647 ↗
• MalfunctionJan 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING SERVICING. IT WAS REPORTED THAT THE DRIVER BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263991 ↗
• MalfunctionJan 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR TLIF SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE IS 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 21195294 ↗
• MalfunctionJan 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHILE INSPECTING VOYAGER INSTRUMENTS NOTICED THAT THE SET SCREW DRIVER WAS 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 21188988 ↗
• MalfunctionDec 10, 2024Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SCREW POSTERIOR FIXATION, POSTERIOR LUMBAR FUSION SPINAL THERAPY. IT WAS REPORTED THAT AFTER THE FINAL TIGHTENING OF THE SET SCREW, THE SET SCREW DEBRIS WAS REMOVED FROM THE DRIVER, BUT IT WAS STUCK AND DID NOT COME OFF. INITIAL SURGERY PROCEDURE WAS OBLIQUE LATERAL INTERBODY FUSION SPINAL THERAPY FOR ADJACENT INTERVERTEBRAL DISORDER. LEVELS IMPLANTED WERE L4/5. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SET SCREW SEEMS IT IS STILL STUCK TO THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890090 ↗
• MalfunctionMay 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING DEVICES USED FOR SPINAL THERAP Y. IT WAS REPORTED THAT THE DRIVER BROKE INTO 4 PIECES AND THE INSERTER BROKE. 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 19399907 ↗
• MalfunctionMay 20, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS, THORACIC PROBE, ROD HOLDER AND RE TRACTOR USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS 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 19349277 ↗
• MalfunctionMar 27, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING TLIF FOR LUMBAR SPINE CENTRAL STENOSIS. IT WAS REPORTED THAT THE SCREWDRIVER WAS BROKEN. NO SPECIFIED PROCEDURE DELAY HAPPENED DUE TO THIS EVENT. NO PATIENT SYMPTOMS AND THRERE WERE NO COMPLICATIONS REPORTED/ANTICIPATED BECAUSE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16617249 ↗
• MalfunctionDec 14, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING INSTRUMENTS IN A LUMBAR FUSION FOR ADULT DEGENERATIVE SCOLIOSIS AT T9-PELVIS. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PRODUCTS WERE USED ON THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15975159 ↗
• MalfunctionMay 5, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR OLIF/PSF L5-S1. IT WAS REPORTED THAT WHEN USING THE SLAP HAMMER ON THE BACK OF THE HANDLE, THE SMALL PIECE THAT HOLDS THE SLAP HAMMER TO THE HANDLE BROKE OFF DURING THE CASE. THERE IS A SMALL INNER PIECE AT THE TIP OF THE SET SCREW DRIVER WHICH BROKE DURING THE CASE. THE SCREW DRIVER WILL NOT RETAIN A SET SCREW. OTHER SET SCREWDRIVER WAS USED FOR THE REST OF THE CASE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775689 ↗