EXPEDIUM 287720170Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034219523), received between Feb 24, 2020 and Apr 28, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREW DRIVER TIPS WERE STRIPPED DURING FINAL TIGHTENING. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016721 ↗
• MalfunctionApr 28, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREW DRIVER TIPS WERE STRIPPED DURING FINAL TIGHTENING. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016576 ↗
• MalfunctionMar 18, 2026Break; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE DRIVERS ARE STRIPPED/SNAPPED FROM USE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629351 ↗
• MalfunctionMar 13, 2026Break; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE DRIVERS ARE STRIPPED/SNAPPED FROM USE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593928 ↗
• MalfunctionMar 5, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE DRIVERS WERE WORN DOWN AND STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523206 ↗
• MalfunctionMar 5, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE DRIVERS WERE WORN DOWN AND STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523196 ↗
• MalfunctionAug 27, 2025Material Deformation; Illegible Information; Material Deformation; Illegible Information

  IT WAS REPORTED THAT THE END OF THE DRIVERS WERE ALL ROUNDED, MAKING FINAL TIGHTENING IMPOSSIBLE. THE PATIENT WAS OK. THERE WAS A DELAY TO THE CASE TO WAITING TIME FOR EXTRA INSTRUMENTS TO BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902743 ↗
• MalfunctionAug 27, 2025Material Deformation; Illegible Information; Material Deformation; Illegible Information

  IT WAS REPORTED THAT THE END OF THE DRIVERS WERE ALL ROUNDED, MAKING FINAL TIGHTENING IMPOSSIBLE. THE PATIENT WAS OK. THERE WAS A DELAY TO THE CASE TO WAITING TIME FOR EXTRA INSTRUMENTS TO BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902678 ↗
• MalfunctionAug 27, 2025Material Deformation; Illegible Information; Material Deformation; Illegible Information

  IT WAS REPORTED THAT THE END OF THE DRIVERS WERE ALL ROUNDED, MAKING FINAL TIGHTENING IMPOSSIBLE. THE PATIENT WAS OK. THERE WAS A DELAY TO THE CASE TO WAITING TIME FOR EXTRA INSTRUMENTS TO BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902660 ↗
• MalfunctionAug 27, 2025Material Deformation; Illegible Information; Material Deformation; Illegible Information

  IT WAS REPORTED THAT THE END OF THE DRIVERS WERE ALL ROUNDED, MAKING FINAL TIGHTENING IMPOSSIBLE. THE PATIENT WAS OK. THERE WAS A DELAY TO THE CASE TO WAITING TIME FOR EXTRA INSTRUMENTS TO BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902646 ↗
• MalfunctionJan 23, 2024Break; Break

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON AN UNKNOWN DATE, THE HEADER OF THE INSTRUMENT WAS BROKEN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. THIS REPORT IS FOR AN EXP ANT X25 TORQUE DRVR SHFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563504 ↗
• InjuryDec 12, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORTHERN IRELAND AS FOLLOWS: IT WAS REPORTED THE FINAL TIGHTENER SCREWDRIVER TIP SNAPPED OFF INSIDE THE SET SCREW. THE PROCEDURE WAS COMPLETED WITH NO DELAY AND NO INJURY TO THE PATIENT. THIS REPORT IS FOR A FINAL TIGHTENER SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959983 ↗
• MalfunctionJun 21, 2021Material Twisted/Bent; Material Twisted/Bent

  THE SURGEON WAS FINAL TIGHTENING AN ANTERIOR EXPEDIUM CONSTRUCT CONSISTING OF TWO SCREWS TWO SET SCREWS AND ONE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036846 ↗
• MalfunctionMar 23, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A LEFT THORACOLUMBAR APPROACH FOR ANTERIOR FUSION FROM T11-L3 THE TIP OF THE X25 SHAFT BECAME DISTORTED AND WOULD NOT LOCK OFF WHEN LOCKING OFF THE SET SCREW. THE DRIVER WAS REPLACED AND ALL SETS SCREWS WERE LOCKED OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) TORQUE DRIVER SHAFT X25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556577 ↗
• MalfunctionApr 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE TAPERED END OF THE EXPEDIUM ANTERIOR FINAL TIGHTENER SHAFT GOT STUCK INSIDE THE COUNTERTORQUE AND WAS IS DIFFICULT TO REMOVE.

  Patient problems: No Patient Involvement

  MAUDE report 9942909 ↗
• MalfunctionFeb 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020, THE FINAL TIGHTENER SHAFT WAS TAPERED AND BECAME STUCK IN THE COUNTER-TORQUE. THE SURGEON USED A NORMAL SHORTER TIGHTENER TO COMPLETE THE PROCEDURE. THIS REPORT IS FOR ONE (1) EXPEDIUM ANTERIOR SPINE SYSTEM TORQUE DRIVER SHAFT X25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745035 ↗