N/A 5484306Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00613994761620), received between Mar 19, 2019 and Mar 17, 2026 — classified as 67 malfunctions.

The most frequently reported specific device problem is “Break” (65 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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615177 ↗
• MalfunctionMar 5, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519175 ↗
• MalfunctionMar 5, 2026Break; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS, COUNTER TORQUES REDUCERS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE OBTURATOR WERE BROKEN AND STRIPPED. RED REDUCER, COUNTER TORQUE, DISTRACTOR, DRIVERS WAS BROKEN. INSERT HOLDERS IN THE HEX DRIVERS ARE BROKEN. ALL DRIVERS WERE BROKEN OR STRIPPED OUTER LOCKING SLEEVE AND COUNTER TORQUES WERE BENT. 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 24515676 ↗
• MalfunctionMar 2, 2026Break; Mechanical Problem; Material Deformation

  ADDITIONAL INFORMATION RECEIVED THAT BOTH THE DRIVERS ARE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480664 ↗
• MalfunctionMar 2, 2026Break; Mechanical Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR SPINAL FUSION SP INAL THERAPY TO L4-S1. IT WAS REPORTED THAT THE SCREWDRIVERS ARE STRIPPED AND DOES NOT FULLY ENGAGE IMPLANT AND INSTRUMENTS 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 24480583 ↗
• MalfunctionFeb 16, 2026Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS BROKEN DURING NORMAL USAGE. THERE IS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342181 ↗
• MalfunctionFeb 13, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332843 ↗
• MalfunctionFeb 13, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332788 ↗
• MalfunctionJan 5, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE THREADED SLEEVE BROKE OFF FROM THE MAIN SCREWDRIVER SHAFT, RESULTING IN INSTRUMENT BREAKAGE. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955333 ↗
• MalfunctionDec 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING SPINAL THERAPY FOR FIXED EXTENSION OPE. IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO FURTHER TIGHTEN THE SCREW, THE TIP OF THE SCREWDRIVER BROKE AND THE FRACTURED PART WAS BURIED IN THE SCREW HEAD. FRACTURED PART OF THE DRIVER WAS NOT EXPLANTED AND THERE IS NO PLAN TO EXPLANT IT. THIS SURGERY WAS REPEAT SURGERY FOR PATIENT AND REASON FOR REPEAT SURGERY WAS ADJACENT INTERVERTEBRAL DISORDER. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23922302 ↗
• MalfunctionNov 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT BREAK OFF HANDLE¿S BLUE RUBBER IS CRACKED, CROSSLINKS DRIVER¿S TIP IS CRACKED/CHIPPED, T-25 OBTURATOR¿S TIP IS WORN DOWN, T-20 DRIVER TIP IS WORN DOWN, RATCHET HANDLES (X2) ARE GETTING STUCK AND WON¿T RATCHET PROPERLY, LOCK SLEEVE DRIVER (X1) HAS A WORN DOWN TIP, LOCK SLEEVE DRIVER (X1) HAS A BROKEN DRIVER TIP AND 4.75 MAS SCREWDRIVER HAS A WORN DOWN TIP. 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 23473453 ↗
• MalfunctionAug 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING L 4-S1 TLIF PROCEDURE IN A PATIENT. IT WAS REPORTED THAT BOTH LOCKING SLEEVE DRIVERS TIPS BROKE OFF FROM DRIVER DUE TO HIGH TORQUE AND STRONG BONE. THE TIPS WERE REMOVED WITHOUT INCIDENT FROM THE TULIP HEAD OF SCREW. THORACIC PROBE IS BENT OUT OF ALIGNMENT AND NOT U SABLE. 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 22920447 ↗
• MalfunctionAug 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING L 4-S1 TLIF PROCEDURE IN A PATIENT. IT WAS REPORTED THAT BOTH LOCKING SLEEVE DRIVERS TIPS BROKE OFF FROM DRIVER DUE TO HIGH TORQUE AND STRONG BONE. THE TIPS WERE REMOVED WITHOUT INCIDENT FROM THE TULIP HEAD OF SCREW. THORACIC PROBE IS BENT OUT OF ALIGNMENT AND NOT U SABLE. 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 22920441 ↗
• MalfunctionAug 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM AN USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A DRIVER INTENDED TO BE USED FOR POSTERIOR LUMBAR FUSION (L4-5) IT WAS REPORTED THAT BEFORE USE FOR SURGERY THAT THE TIP OF THE SCREWDRIVER WAS MISSING. THEY HAD ANOTHER SCREWDRIVER AVAILABLE AND USED THAT ONE INSTEAD 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 22716150 ↗
• MalfunctionJun 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD VERY HARD BONE, AND THE TIP OF THE SCREWDRIVER CHIPPED OFF. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22156839 ↗
• MalfunctionMay 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A SPINAL PROCEDURE, THE HANDLE AND SCREWDRIVER EXPERIENCED INSTRUMENT BREAKAGE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE HANDLE IS STUCK AND WON¿T RATCHET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010625 ↗
• MalfunctionMar 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR FUSION WITH PEDICLE SCREW IMPLANTATION THERAPY FOR LUMBAR STENOSIS. LEVELS IMPLANTED WERE L3-S1. IT WAS REPORTED THAT THE DOCTOR WAS TRYING TO IMPLANT PEDICLE SCREWS IN TO THE PATIENT ENCOUNTERED AN ISSUE WHERE THE TIPS OF BOTH SCREWDRIVERS BROKE OFF IN THE DENSE BONE. HOWEVER, THE BROKEN TIPS WERE SUCCESSFULLY REMOVED, ALLOWING THE SURGERY TO CONTINUE WITHOUT FURTHER ISSUES. 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 21650185 ↗
• MalfunctionMar 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR FUSION AT L4-S1. IT WAS REPORTED THAT THE SCREWDRIVER SLEEVE BROKE OFF FROM THE SHAFT. 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 21512159 ↗
• MalfunctionFeb 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT TIP OF SCREWDRIVER BROKE OFF IN MAS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE TIP WAS BROKEN ON BACK TABLE WHEN WE WERE PREPPING FOR THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341859 ↗
• MalfunctionFeb 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS USED FOR SPINAL THERAPY. IT WAS RE PORTED THAT RATCHETING HANDLE BROKE AND THE PROBE EXPERIENCED AN ISSUE WHERE THE NAV LOCK FRAME WOULD NOT SLIDE IN AND SLEEVE DRIVERS WAS BROKEN. THE TIP OF THE NAV AND MAS DRIVERS 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 21320362 ↗
• MalfunctionFeb 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS USED FOR SPINAL THERAPY. IT WAS RE PORTED THAT RATCHETING HANDLE BROKE AND THE PROBE EXPERIENCED AN ISSUE WHERE THE NAV LOCK FRAME WOULD NOT SLIDE IN AND SLEEVE DRIVERS WAS BROKEN. THE TIP OF THE NAV AND MAS DRIVERS 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 21320347 ↗
• MalfunctionFeb 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN LUMBAR FUSION. IT WAS REPORTED THAT THE SCREWDRIVER WAS DISCOVERED TO BE BROKEN PRIOR TO USE. THE LEVELS IMPLANTED WERE L4-L5. THERE WAS NO PATIENT INVOLVED IN THIS EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PRODUCT WAS USED AND NOT DELIVERED DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318581 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING DEVICES USED IN LUMBAR FUSIONS. IT WAS REPORTED THAT ALL DRIVERS WERE EITHER BROKEN OR WORN SUCH THAT THEY NO LONGER WORK PROPERLY. 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 21303592 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A EVENT. IT WAS REPORTED THAT THE DRIVERS ARE WORN OR BROKEN TO THE POINT THEY CAN'T BE SAFELY USED IN PROCEDURES. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301372 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REMOVAL OF IMPL ANTED HARDWARE FOR ACUTE IMPLANT PAIN. IT WAS REPORTED THAT 3 INDIVIDUAL DRIVERS BROKE DURING THE PROCEDURE. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCTS WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS A REVISION LUMBAR FUSION WITH A HARDWARE REMOVAL. THE PRODUCT WAS BROKEN DURING THE PROCEDURE, BUT DID NOT COME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290438 ↗