N/A 5584009Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00643169064157), received between Feb 12, 2020 and Sep 2, 2026 — classified as 4 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Break” (39 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50557953 ↗
• MalfunctionApr 28, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR FI XATION. IT WAS REPORTED THAT THE DRIVER END WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS THE PRODUCT WAS USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010838 ↗
• MalfunctionFeb 27, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT BROKE OFF AT THE BASE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT THE PROCEDURE INVOLVED WAS POSTERIOR FIXATION FOR ADULT SPINAL CURVATURE. THE BASE BROKE DURING SET SCREW THREADING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468822 ↗
• MalfunctionFeb 19, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS ADOLESCENT IDIOPATHIC SCOLIOSIS. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN WHILE TIGHTENING INTRA-OPERATIVELY. PROCEDURE PERFORMED WAS COMPRESSION/DISTRACTION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386120 ↗
• MalfunctionFeb 3, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS USED FOR DEFORMITY CASE. IT WAS RE PORTED THAT THE INSTRUMENTS WERE STRIPPED AND PRODUCT WAS USED PREVIOUSLY WITHOUT MALFUNCTION. 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 24245359 ↗
• MalfunctionFeb 3, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS USED FOR DEFORMITY CASE. IT WAS RE PORTED THAT THE INSTRUMENTS WERE STRIPPED AND PRODUCT WAS USED PREVIOUSLY WITHOUT MALFUNCTION. 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 24245338 ↗
• MalfunctionDec 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777215 ↗
• MalfunctionJun 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE TIP OF A "BREAK OFF DRIVER" INSTRUMENT BROKE OFF DURING PROPER USE. NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. THE BROKEN TIP WAS DISCARDED IN A SHARPS CONTAINER BY THE SCRUB NURSE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184856 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A DRIVER TO BE USED ON A PATIENT IN AN L3-L5 POSTERIOR LUMBAR FUSION WITH REDUCTION SCREWS FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT WHEN PREPARING FOR SURGERY, THE REP NOTICED THAT THE RMAS BREAK OFF DRIVER TIP WAS BROKEN. THEY REMOVED THE DRIVER OFF THE FIELD BEFORE SURGERY BEGAN AND INSPECTED THE DRIVER POST-OP TO DETERMINE THAT THE TIP OF THE DRIVER WAS BROKEN. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PRODUCT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289839 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237075 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237073 ↗
• 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 21236334 ↗
• MalfunctionJan 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING REDUCTION BREAK OFF DRIVER USED FOR BREAKING OFF REDUCTION MAS SET SCREWS. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN PRE OP. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE BROKEN INSTRUMENT HAS BEEN IN USE FOR SOME TIME. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215836 ↗
• MalfunctionJan 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING DEVICES USED FOR TLIF. IT WAS REPORTED THAT THE DEVICES 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 21193192 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST-OP. 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 21187802 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST-OP. 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 21187801 ↗
• MalfunctionJan 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT THAT WAS USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN, TORQUE LIMITING HANDLE WILL NOT TORQUE OUT AND SCREW FALLS OUT FROM DRIVER. THERE WAS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCTS WERE ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186260 ↗
• MalfunctionJan 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED IN TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE INSTRUMENT BROKE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE ISSUE HAPPENED AT THE BACK TABLE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21155326 ↗
• MalfunctionJan 9, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR AIS THERAPY. IT WAS REPORTED THAT THE TIP OF THE DRIVER DOESN¿T TIGHTLY FIGHT THE SCREWS. 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 21109694 ↗
• MalfunctionNov 28, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING SPINAL THERAPY FOR T3-L1 SCOLIOSIS. IT WAS REPORTED THAT THE END OF THE TORQUE WRENCH BROKE AND NO LONGER WORKED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE ERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808413 ↗
• MalfunctionOct 28, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTE RBODY FUSION (TLIF). IT WAS REPORTED THAT THE DRIVER 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 20542355 ↗
• MalfunctionJun 21, 2024Naturally Worn; Naturally Worn

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT INSTRUMENT HEAD OF DRIVER IS WORN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581209 ↗
• MalfunctionApr 12, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PSF ADOLESCENT IDIOPATHIC SCOLIOSIS. IT WAS REPORTED THAT THE SCREWDRIVER TIP FRACTURED. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS RE MAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096309 ↗
• MalfunctionFeb 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF L2-S1 FOR SPINAL STENOSIS. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. 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 18786255 ↗
• MalfunctionAug 18, 2023Break; Use of Device Problem; Break; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY FOR SYMPTOMATIC SCOLIOSIS. IT WAS REPORTED THAT BREAK-OFF SCREWDRIVER WAS USED INCORRECTLY TO THREAD THE BREAK-OFF SET SCREW, AND THE TIP WAS BROKEN. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17570083 ↗