EXPEDIUM 279702140Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034198521), received between Nov 4, 2020 and Dec 19, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THE PATIENT UNDERWENT A POSTERIOR VERTEBRAL FIXATION. NO ISSUES WERE REPORTED DURING THE PROCEDURE AND IT WAS COMPLETED SUCCESSFULLY WITH NO DELAY. WHILE PUTTING THE INSTRUMENTATION AWAY, IT WAS NOTED THE SCREWDRIVER WAS TOO TIGHT AND NOT ABLE TO BE REMOVED FROM THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850061 ↗
• MalfunctionJul 25, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: THE ELLIPTICAL HANDLES BROKE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) ELLIPTICAL HANDLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390074 ↗
• MalfunctionJul 25, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: THE ELLIPTICAL HANDLES BROKE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) ELLIPTICAL HANDLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390023 ↗
• MalfunctionMar 29, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, RED RESIDUES APPEAR ON THE INSTRUMENT´S HANDLE, WHICH CANNOT BE EXPLAINED BY THE CSSD AND THE THEATRE-MANAGEMENT. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM ELLIPTICAL HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16638507 ↗
• MalfunctionJul 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, IT WAS NOTICED THAT ON THE ELLIPTICAL HANDLE, THE CONNECTION BETWEEN THE BLACK HANDLE AND THE PINK RING WAS LOOSE. THIS REPORT IS FOR AN EXPEDIUM ELLIPTICAL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188959 ↗
• MalfunctionApr 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR SPINAL FUSION. THE SCRUB NURSE PREOPERATIVELY TRIED TO CONNECT THE HEAD ADJUSTER TO A TEARDROP HANDLE (279702120), WHICH FAILED. ALSO, TRIED TO CONNECT THE HEAD ADJUSTER WITH ANOTHER COUNTERPART HANDLES SUCH AS 279702140, 286715300, AND 299704135, WHICH ALL WAS FAILED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) ELLIPTICAL HANDLE. THIS REPORT IS 3 OF 5 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11756020 ↗
• MalfunctionMar 11, 2021Calibration Problem; Calibration Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE X25 DRIVER WAS BEING USED WITH A TORQUE HANDLE TO PERFORM THE FINAL TIGHTENING OF THE SET SCREWS, WHEN THE TIP WOULDN¿T ENGAGE PROPERLY. THE THREADS ON THE TIP OF THE DRIVER WERE BENT SO A DIFFERENT X25 DRIVER WAS USED TO COMPLETE THIS STAGE OF THE SURGERY. CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) ELLIPTICAL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464296 ↗
• InjuryNov 4, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR L5-S1 TLIF PROCEDURE. IT WAS DISCOVERED THAT TPAL SET WERE DELIVERED WITHOUT THE APPLICATOR INSTRUMENTS. IT WAS UNKNOWN WHEN DISCOVERED THAT THE APPLICATOR SHAFT IS MISSING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15-20 MINUTES DELAY. THE PATIENT HAS INFECTION AND PAIN. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) ELLIPTICAL HANDLE. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Tissue Injury

  MAUDE report 10786212 ↗