N/A 7480144Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00721902853586), received between Jul 8, 2021 and Nov 5, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 23473390 ↗
• MalfunctionFeb 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED FOR POSTERIOR LUMBAR FUSION. IT WAS REPORTED THAT PROBE, GRIPPER AND BREAK OFF DRIVER BROKE, AND PROVISIONAL DRIVER WOULD NOT RETAIN SET SCREWS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21352043 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY(UF) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE BOTH OF BREAK-OFF DRIVERS HAVE THE SAME FAILURE. OVER THE COURSE OF USE OVER MULTIPLE YEARS THE INTERNAL TABS THAT RETAIN THE SET SCREWS INSIDE THE DRIVER SHAFT HAVE BROKEN OFF. THEREFORE, THE DRIVERS DO NOT RETAIN THE BREAK-OFFS APPROPRIATELY. IF THE DRIVER IS TURNED UPSIDE DOWN, THEY WOULD FALL OUT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT SO, NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289697 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY(UF) VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE METAL TAB ON TOP OF THE DRIVER WAS BROKEN AND THE INSTRUMENT WAS BROKEN AND WOULD NOT RETAIN BROKEN SET SCREW PIECES. THERE WAS NO PATIENT INVOLVED IN THIS EVENT SO, NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280888 ↗
• MalfunctionMay 15, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN DURING ROUTINE INSPECTION. NO PATIENT OR SURGERY WAS AFFECTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19318663 ↗
• MalfunctionJul 8, 2021Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT SPINAL THERAPY FOR THORA CIC COMPRESSION FRACTURE. IT WAS REPORTED THAT THE SET SCREW STRIPPED THREE TIMES AT THE TIME OF FINAL TIGHTENING FOR ONE TH11 SCREW. THE DRIVER WAS CHANGED, AND IT WAS ABLE TO TIGHTEN WHILE PUSHING THE ROD. THE DRIVER WAS BROKEN AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. THE PROCEDURE INVOLVED IN THE EVENT WAS TH11-L1 ANTERIOR FUSION. LEVELS IMPLANTED WAS TH11-L1. ON (B)(6) 2021 (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE LOT NUMBERS ARE UNKNOWN. THERE IS A POSSIBILITY OF THE DRIVER BEING STRIPPED AND REPORTED PRODUCTS WERE USED IN THE SURGICAL FIELD. ON 2021-JUN-24 (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ALL THE THREE SCREWS WERE USED AND STRIPPED IN THIS EVENT. HENCE, THE PLI 30 AND PLI 40 ARE ADDED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134037 ↗