EXPEDIUM 3010-19-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034561394), received between Feb 1, 2022 and Feb 3, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT TWO (2) SCREWDRIVERS BROKE DURING S1 ILIAC SCREW INSERTION. THERE WAS MINOR DELAY AND NO PATIENT CONSEQUENCE, NO PATIENT HARM. IT WAS FURTHER REPORTED THAT THE TWO (2) SLEEVES ALSO BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249152 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT TWO (2) SCREWDRIVERS BROKE DURING S1 ILIAC SCREW INSERTION. THERE WAS MINOR DELAY AND NO PATIENT CONSEQUENCE, NO PATIENT HARM. IT WAS FURTHER REPORTED THAT THE TWO (2) SLEEVES ALSO BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249147 ↗
• MalfunctionJan 21, 2025Break; Break

  IT WAS REPORTED THAT DUE TO THE CANNULATION, THE DRIVER'S BREAK OFF AT THE END EASILY. MULTIPLE DRIVERS WERE BROKEN DURING THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196705 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING POST OP INSPECTION, IT WAS FOUND THAT INSTRUMENTS WERE BROKEN. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821521 ↗
• MalfunctionApr 17, 2024Break; Contamination /Decontamination Problem; Mechanical Jam; Break; Contamination /Decontamination Problem; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRIVER WAS STRIPPED SO WASN'T PICKING UP SCREW APPROPRIATELY AND THE TAB ON THE SLEEVE HAD DEBRIS BONE SO IT WAS PERMANENTLY PUSHED DOWN AND RELEASING SLEEVE OFF DRIVER AND BROKE MECHANISM TO RETAIN TO DRIVER. THE INCIDENT HAPPENED TWICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE 5.5 NAV DRIVER - SLEEVE THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127860 ↗
• MalfunctionApr 17, 2024Break; Contamination /Decontamination Problem; Mechanical Jam; Break; Contamination /Decontamination Problem; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRIVER WAS STRIPPED SO WASN'T PICKING UP SCREW APPROPRIATELY AND THE TAB ON THE SLEEVE HAD DEBRIS BONE SO IT WAS PERMANENTLY PUSHED DOWN AND RELEASING SLEEVE OFF DRIVER AND BROKE MECHANISM TO RETAIN TO DRIVER. THE INCIDENT HAPPENED TWICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE 5.5 NAV DRIVER - SLEEVE THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127744 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE DRIVER SLEEVE BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 5.5 NAV DRIVER - SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17836037 ↗
• MalfunctionFeb 7, 2023Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS A POSTERIOR CERVICAL SPINE FUSION USING SYMPHONY. THE SURGERY WAS NOT AFFECTED BECAUSE THERE WERE TWO DEVICES ON HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315191 ↗
• MalfunctionFeb 1, 2022Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2021, THE EXPEDIUM NAVLOCK 5.5 CANNULATED DRIVER TIP SNAPPED OFF INTO THE SCREW SHAFT. THE PATIENT WAS NOT HARMED. DUE TO THE CANNULATION OF THE DRIVER TIP, IT WAS POSSIBLE TO PULL OUT THE TIP FROM THE SCREW HEAD AND ADVANCE THE SCREW WITH A NEW DRIVER. THE SCREW WAS FINE AND THE BROKEN TIP WAS ABLE TO BE REMOVED. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE (1) NAVIGATION ENABLED INSTRUMENTS EXPEDIUM DRIVER - SLEEVE 5.5. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417648 ↗