EXPEDIUM 279712550Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM SI INTERMEDIATE TIGHTENER x25 · Class 1
All models of EXPEDIUM (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medos Expedium spine system surgical tightening instrument, a reusable driver used during spine procedures to tighten screws. The 27 reports mostly describe the tool wearing out over years of use — its shaft or tip twisting, bending, or stripping so it no longer grips, with one report of a break and one of deformation. No deaths or injuries are mentioned, and in each case the surgery continued with a replacement instrument and no delay. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705034198989), received between Aug 16, 2018 and Mar 20, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (26 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent26
- Break1
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT X25 FINAL TIGHTENER, XPDM THORACIC PEDICLE PRB, ST, XPDM SI INTERMEDIATE TIGHT X25, AND BALL TIP FEELER STRAIGHT BECAME STRIPPED OR BENT OUT OF SHAPE DUE TO YEARS OF USE AND REGULAR WEAR AND TEAR AT A HOSPITAL. THE AFFECTED INSTRUMENTS WERE SET ASIDE AFTER BEING IDENTIFIED AS DAMAGED, AND WERE IMMEDIATELY REPLACED WITH NEW INSTRUMENTS DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647704 ↗MalfunctionJan 9, 2026Mechanical Problem; Material Twisted/Bent
IT WAS REPORTED THAT THE TORQUE HANDLE NO LONGER WORKS, AND THE WRENCH IS STRIPPED. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24023793 ↗MalfunctionDec 23, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER STRIPPED ON FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878123 ↗MalfunctionDec 23, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER STRIPPED ON FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878106 ↗MalfunctionDec 23, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER STRIPPED ON FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878094 ↗MalfunctionDec 23, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER STRIPPED ON FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878091 ↗MalfunctionDec 23, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER STRIPPED ON FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878071 ↗MalfunctionDec 23, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER STRIPPED ON FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878047 ↗MalfunctionNov 6, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVER STRIPPED AND FLEX CLIP WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23486111 ↗MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PRODUCT WAS WORN DUE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285352 ↗MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PRODUCT WAS WORN DUE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285264 ↗MalfunctionSep 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2025, PRODUCT WAS DAMAGED/TWISTED UPON INSERTION OF A PEDICLE SCREW. IT IS UNKNOWN IF SURGERY WAS DELAYED DUE TO THE REPORTED EVENT AND IF PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22978119 ↗MalfunctionSep 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2025, THE PRODUCT WAS DAMAGED/TWISTED UPON INSERTION OF A PEDICLE SCREW. IT IS UNKNOWN IF SURGERY WAS DELAYED DUE TO THE REPORTED EVENT AND IF PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22978076 ↗MalfunctionSep 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT FINAL TIGHTENER AND DRIVERS STRIPPED ON TIGHTENING. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965312 ↗MalfunctionSep 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT FINAL TIGHTENER AND DRIVERS STRIPPED ON TIGHTENING. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965301 ↗MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DRIVER AND TORQUE SHAFT WERE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22464281 ↗MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DRIVER AND TORQUE SHAFT WERE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22464276 ↗MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DRIVER AND TORQUE SHAFT WERE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22464275 ↗MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DRIVER AND TORQUE SHAFT WERE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22464271 ↗MalfunctionFeb 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED DURING CASE SETUP WE NOTICED WEAR AND TEAR OF INSTRUMENTS. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312109 ↗MalfunctionSep 13, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LONG HANDLE SCREW DRIVER WAS STRIPPED. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) XPDM SI INTERMEDIATE TIGHT X25.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20216496 ↗MalfunctionJul 15, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2024, THE DRIVER STRIPPED UPON FINAL TIGHTENING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM SI INTERMEDIATE TIGHTENER X25. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19742732 ↗MalfunctionJul 15, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2024, THE DRIVER STRIPPED UPON FINAL TIGHTENING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM SI INTERMEDIATE TIGHTENER X25. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19742705 ↗MalfunctionJul 11, 2023Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE TIGHTENER IN QUESTION MALFUNCTIONED. THERE WAS NO ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY USING ANOTHER ITEM OF THE SAME TYPE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI INTERMEDIATE TIGHTENER X25. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17297517 ↗MalfunctionDec 28, 2022Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MDRD NOTICED THAT THE INTERMEDIATE TIGHTENER X25 FROM THE EXPEDIUM SET WAS STRIPPED ON THE DISTAL END. IT WAS REMOVED FROM CIRCULATION. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI INTERMEDIATE TIGHTENER X25. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16060080 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page