N/A 8350393Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994597793), received between Oct 1, 2018 and Feb 23, 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.

• MalfunctionFeb 23, 2025Break; Mechanical Jam; Break; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MEDTRONIC REPRESENTATIVE REGARDING DRIVER USED IN POSTERIOR FUSION. IT WAS REPORTED THAT THE DRIVER WAS USED TO REMOVE PREVIOUS INSTRUMENTATION. THE DRIVER HEAD WAS STUCK INSIDE OF THE SCREW HEAD AND WHILE TURNING THE INSTRUMENT, THE HEAD OF THE SCREW DRIVER BROKE OFF INSIDE THE SCREW HEAD. INSTRUMENTATION WAS REMOVED WITH OTHER DRIVERS AND THE SURGERY WAS SUCCESSFUL. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS REMOVAL OF PREVIOUS INSTRUMENTATION. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442896 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING DEVICE MAINTENANCE. IT WAS REPORTED THAT THE DRIVERS BROKE. NO PATIENT INVOLVEMENT IS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280923 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING DEVICE MAINTENANCE. IT WAS REPORTED THAT THE DRIVERS BROKE. NO PATIENT INVOLVEMENT IS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280908 ↗
• MalfunctionMay 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREWDRIVER DOES NOT RETAIN BROKEN OFF SET SCREWS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT FOR THE DRIVERS, BOTH TIPS BROKE OFF. THE TIPS WERE RECOVERED AND THROWN AWAY. THE PROVISIONAL DRIVER WAS VERY DIRTY AND COULD NOT BE CLEANED. THE TUBE WAS OLD AND HAS SIGNIFICANT SIGNS OF WEAR FROM BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19401378 ↗
• MalfunctionMay 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREWDRIVER DOES NOT RETAIN BROKEN OFF SET SCREWS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT FOR THE DRIVERS, BOTH TIPS BROKE OFF. THE TIPS WERE RECOVERED AND THROWN AWAY. THE PROVISIONAL DRIVER WAS VERY DIRTY AND COULD NOT BE CLEANED. THE TUBE WAS OLD AND HAS SIGNIFICANT SIGNS OF WEAR FROM BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19401287 ↗
• MalfunctionOct 1, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH ADJACENT LEVEL DDD ( DEGENERATIVE DISK DISEASE) AND UNDERWENT SURGERY AT L4 LEVEL. DURING THE SURGERY, THE TIP OF THE DRIVER BROKE OFF. THE SCREWDRIVER INTERFACE WITH THE BONE BECAME SO HARD THAT IT STOPPED TURNING AND AS A RESULT THE TIP OF THE SCREW DRIVER BROKE OFF. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE DRIVER WERE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7921643 ↗